TRIAD Clinical Research Studies

Health Electronic Assessment of Risks and Trends Using Biometric Equipment and Technology (HEARTBEAT)

Start Date: October 8, 2024
NCT Number: NCT06753045

Summary:

A prospective, single-arm, non-interventional longitudinal study that plans to enroll up to 10,000 adults with and without established cardiovascular disease. Participants wear a Samsung Galaxy smartwatch for at least 18 hours per day for one year. The study collects daily single-lead ECGs and passive data including photoplethysmography, heart rate, heart-rate variability, oxygen saturation, sleep, physical activity, body composition, smartwatch compliance, and participant-reported surveys. These data are linked with electronic health records to evaluate cardiovascular outcomes. The study aims to use these large amounts of smartwatch data to develop algorithms that could identify warning patterns before or during major cardiovascular events, such as a stroke, heart attack, worsening heart failure, or abnormal heart rhythm, potentially allowing patients to seek medical care earlier.

Aim:

• To study The Association Between Smartwatch-Derived Biometrics and Cardiovascular Events
• Establish Biometric “Fingerprints” for Disease Identification and Labeling

Primary endpoint:

• Association between smartwatch biometrics and major adverse cardiovascular events, including cardiovascular death, acute myocardial infarction, stroke.

NCT Number: Not Submitted

Summary:

TRIAD is a retrospective, randomized, database for chart review of patients having different types of arrhythmia and those patients who have been identified as being at risk for the development of arrhythmia. The target population will include the patients at the Tulane University Medical Centre who are experiencing or are at risk of arrhythmia. The patients will be included in TRIAD database if they are 18 years of age and above, have risk factors including but not limited to having either paroxysmal or persistent atrial fibrillation (AFib), or symptoms of AFib like irregular heartbeat, shortness of breath and fatigue. The medical records of the patients including but not limited to diagnostics, disease history, ECG data, MRI scans, medications used, procedures undergone and data from the follow-up visits will need to be accessed.

Summary:

This is a prospective observational pilot study. Fifteen mild to severe OSA patients and fiveage-and BMI-matched controls will undergo a DE-MRI. Demographics, medical history and polysomnography results will be collected. Patients will be followed over a period of 6 months with a wearable device (WATCHPAT 300) that will record a home sleep apnea study biweekly, including OSA metrics like AHI and nocturnal oxygen variations. Patients will also use an ECG Check device for arrhythmia detection. The primary study outcome is percent of fibrosis at baseline and its progression. Other outcomes include arrhythmia occurrence. These 20 patients will then be included in the PROOF study if they wish to continue

Aim:

• To prove the presence and progression of atrial fibrosis on DE-MRI in OSA patients without atrial fibrillation.
• To investigate the correlation between OSA metrics (nocturnal oxygen saturation and Apnea Hypopnea Index (AHI))and degree of fibrosis at baseline and its progression.
• This study will be base for PROOF study (PROgression Of Fibrosis in OSApatients), a prospective observational study aiming to investigate the relation between OSA and its therapy and atrial fibrosis progression

Summary:

Cross sectional cohort study.
To create, train, and potentially validate a deep neural network using PPG signals from commercially available wristbands to predict left ventricular ejection fraction on echography.

Outcomes:

The primary outcome of interest will be the association between obtained PPG waveforms and recorded ejection fractions.
Secondary analyses will focus on additional echocardiographic characteristics for other potential associations with PPG waveform.
The association between blood pressure and PPG will also be investigated.
We hypothesize that differences in EF should correlate to the same differences seen on PPG waveforms. Therefore, to test this hypothesis, we aim to create and train a predictive neural network using PPG signals to predict ejection fraction.

Aim:

• To investigate the association between ejection fraction determined by echocardiography and signals obtained from PPG in the general population.
• To investigate the association between blood pressure and signals obtained from PPG in the general population.
• To investigate the association between signals obtained from PPG in the general population to cardioechographic findings such as, valvular heart disease, structural heart diseases, cardiomyopathies, pericardial disease etc.

Summary:

A retrospective cohort study including all AF patients diagnosed in the last 10 years.

Aim:

• Analyze the demographics and clinical characteristics of AF patients in Louisiana
• Evaluate the anticoagulant and management strategy of AF patients in Louisiana
• Investigate the effect of demographics and medical history on clinical outcomes in AF population.

NCT Number: Not Submitted

Summary:

A prospective, observational pilot study evaluating whether left atrial fibrosis measured by cardiac MRI before surgery can predict post-operative atrial fibrillation and other atrial arrhythmias in patients undergoing cardiac surgery without a previous history of AF. Participants undergo preoperative cardiac MRI followed by standard-of-care surgery and in-hospital heart-rhythm monitoring. By identifying patients at higher risk before surgery, the study may support earlier preventive measures, reduce complications and hospital stays, and improve recovery after cardiac surgery.

Aim:

• Evaluate and compare the incidence of POAF for up to 2 months post-surgery stratified by baseline Utah fibrosis stages and overall fibrosis (%) of the left atrial wall area. We hypothesize that patients with a higher baseline Utah fibrosis staging will experience a higher incidence of POAF.
• Evaluate and compare the in-hospital mortality, length-of-stay (LOS), complication rates (strokes, pneumonia, respiratory failure etc.) of the different Utah fibrosis stage cohorts. Perform cost analysis and compare between patients with POAF and patients without POAF. We hypothesize that patients experiencing POAF will have a higher mortality rate, longer LOS, greater complications, and therefore, additional hospital costs.

Start date: February 6, 2025
NCT Number: Not assigned.

Summary:

An active cardiovascular research biobank approved to enroll 200 adults with cardiovascular disease and healthy individuals serving as controls. The biobank collects and stores blood and cardiac tissue samples. These samples support DNA and RNA analyses, gene and protein studies, biomarker discovery, cell-line development, and other cardiovascular research. No procedure is performed solely to collect samples: additional blood is obtained during clinically indicated blood draws, and tissue is collected only when it would otherwise be discarded during surgery. By connecting biological samples with clinical information, the biobank helps researchers understand why cardiovascular diseases develop differently among individuals and accelerates the discovery of personalized approaches for prevention, earlier diagnosis, and more effective treatment.

Aim:

• To assess high-quality biological samples and associated clinical information for cardiovascular research.

Senescence and Atrial Fibrosis

Start date: 
NCT Number: 

Summary:

A pilot, single-center preclinical study using 55 Yucatan models to investigate whether cellular senescence drives the development of atrial fibrosis, and to build a translational model of atrial fibrosis. Models are divided into an Induced Fibrosis group (40 models; four subgroups of 10 undergoing atrial tachypacing, ethanol or bleomycin Vein of Marshall injection, or low-power catheter ablation), a Control group (6 models: 3 young, 3 old, receiving no intervention to characterize normal aging), and a Sham group (9 models undergoing sham procedures matched to each induction method). All models undergo baseline cardiac MRI and blood draws; Induced Fibrosis and Sham models then undergo their assigned procedure, with serial MRI at track fibrosis burden, followed by terminal blood draw and tissue collection at endpoint. Histopathology, multi-omics (ATAC-seq/RNA-seq, spatial transcriptomics, mass spectrometry), and imaging data are compared across groups to distinguish senescence- and aging-related fibrosis signatures from those of procedurally induced fibrosis.

Aim:

• To test whether senescent atrial cells significantly contribute to the development of atrial fibrosis
• To develop and characterize an atrial fibrosis model across multiple induction methods (ATP, ethanol/bleomycin VOM injection, low-power catheter ablation)
• To compare histologic, omics, and imaging signatures between fibrotic and non-fibrotic tissue, and between naturally aging-related fibrosis and induced fibrosis, in order to define the molecular signature of senescence-driven atrial fibrosis

Primary endpoint:

Per-model experimental endpoint of achieving ≥20% atrial fibrosis on cardiac MRI, or reaching 2 months post-enrollment without reaching that threshold, at which point the model undergoes final MRI, blood draw, and tissue collection for histologic and omics analysis.

Multicenter Registry of Atrial Fibrillation Ablation for Machine Learning Based Prediction of Ablation Outcomes and Favorable Lesion Sets

Start date: 
NCT Number: 

Summary:

A prospective, multicenter registry following adults with paroxysmal or persistent atrial fibrillation (AF) undergoing their first or a repeat catheter ablation. The registry targets 1,800 participants with 12 months of follow-up. An MRI substudy will include 100 participants undergoing cardiac MRI 28–42 days after ablation to assess ablation lesions and support machine learning analyses.

Aim:

• To identify patient and procedural factors associated with safe and successful AF ablation.
• To use machine learning, including MRI findings from the substudy, to predict ablation outcomes and identify patterns of ablation lesions associated with better results.

Primary endpoint:

• AF Recurrence post ablation.

A randomized, multicenter trial comparing two pulsed field ablation systems – VARIPULSE PRO™ and FARAWAVE™ – in patients with symptomatic persistent atrial fibrillation (AF) undergoing their first catheter ablation. The study plans to enroll 416 randomized participants, with follow-up for 12 months after the procedure.

Aim:

To compare the safety and effectiveness of the two ablation systems in treating persistent AF.

Primary endpoints:

• Safety: To compare the safety of the two ablation systems.
• Effectiveness: To compare AF Recurrence after ablation.
• Secondary: To Evaluate Improvement in quality of life following ablation

Summary:

A prospective, randomized, international, multicenter trial focused on detecting previously undiagnosed atrial fibrillation (AF) and evaluating early catheter ablation in patients with heart failure and mildly reduced or preserved ejection fraction (HFmrEF/HFpEF; LVEF >40%). The study compares pulsed field catheter ablation with medical AF therapy, alongside optimal heart failure treatment, with continuous AF monitoring and three years of follow-up.

Aim:

• To screen for previously undiagnosed AF in patients with HFmrEF/HFpEF.
• To evaluate whether early catheter ablation improves clinical outcomes compared with medical therapy in patients with newly diagnosed AF and HFmrEF/HFpEF.

Primary endpoint:

• To assess whether early catheter ablation leads to better outcomes by comparing deaths, strokes, hospital admissions and outpatient episodes of worsening heart failure, and reductions in NT-proBNP – a blood marker of heart function.

Safety and Lesion Characterization of High-Flow Varipulse Pulsed Field Ablation in Atrial Fibrillation

NCT Number: Not submitted.

Summary:

A retrospective, observational, single-center study of approximately 150 patients with atrial fibrillation (AF) treated with VARIPULSE™ catheter for pulsed field ablation. The study examines procedural safety, ablation lesion formation and durability using late gadolinium enhancement cardiac MRI (LGE-MRI), and clinical outcomes.

Aim:

• To evaluate safety during and shortly after ablation.
• To assess the formation and durability of ablation lesions using cardiac MRI and evaluate clinical outcomes.

Primary endpoint:

• Safety: Major complications within seven days of ablation, assessed as a combined measure such as stroke, major bleeding, cardiac tamponade or death.
• Effectiveness: AF recurrence within 6 months

NCT Number: To be confirmed.

Summary:

A prospective, multicenter, single-arm pilot study enrolling 60 patients with paroxysmal atrial fibrillation (AF) in the United States and Germany. The study evaluates an individual electrogram-guided ablation strategy using VARIPULSE™, where electrical signals guide energy delivery and additional ablation is performed only when needed. Echocardiography and cardiac MRI before and after ablation assess changes in heart tissue and function.

Aim:

• To evaluate whether an ablation strategy guided by electrical signals can limit unnecessary energy delivery while maintaining effective AF treatment.
• To assess procedural safety and preservation of left atrial function.

Study endpoints:

• Procedural success: Successful AF ablation and freedom from AF within 12 months
• Left atrial function: Changes in the structure, scar tissue, and pumping function
• Safety: Occurrence of stroke, cardiac tamponade or stenosis of the pulmonary veins.

Cardiac Myopathy in Relation to Age: The MiRAGE Pilot Study

NCT Number: Not Assessed

Summary:

A cross-sectional, observational study enrolling 500 adults of varying ages to examine age-related changes in atrial and ventricular structure, function, and fibrosis. Participants will undergo late gadolinium enhancement cardiac MRI (LGE-CMR). In a subset of patients with atrial fibrillation undergoing catheter ablation, MRI findings will also be compared with electroanatomical mapping obtained during the procedure. By showing how aging and other health conditions contribute to scarring and remodeling throughout the heart, this study may improve early detection and risk assessment for a broad range of cardiovascular diseases and complications using MRI.

Aim:

• To evaluate the relationship between age, comorbidities, and atrial and ventricular myopathy.
• To characterize age-related cardiac fibrosis and structural remodeling using LGE-CMR.

Endpoint:

• Primary: Association of age and comorbidities with atrial and ventricular myopathy, including atrial function, atrial fibrosis, atrial volume, ventricular extracellular volume, ventricular volumes, and ventricular late gadolinium enhancement.
• Secondary: Agreement and relationship between left atrial findings on LGE-CMR and electroanatomical mapping obtained during atrial fibrillation ablation.

Detection of Atrial Fibrillation and Normal Sinus Rhythm Segments Using Photoplethysmography from Smartphone Cameras

NCT Number: Not Assessed

Summary:

A prospective, non-randomized, multicenter diagnostic study enrolling at least 554 adults across at least three clinical sites. Participants will complete a photoplethysmography recording using Happitech’s Heart Rhythm Software on a smartphone while simultaneously undergoing a 12-lead ECG. The smartphone algorithm’s rhythm classification will be compared with ECG interpretations. If proven accurate, this technology could make AF screening more accessible by allowing people to check their heart rhythm using a smartphone camera.

Aim:

• To evaluate the ability of a smartphone camera-based PPG algorithm to detect atrial fibrillation and normal sinus rhythm.
• To assess whether algorithm performance differs according to skin tone, ethnicity, race, sex, body mass index, age, or smartphone type.

Primary endpoint:

• Accuracy of the Heart Rhythm Software for detecting atrial fibrillation compared with the simultaneously recorded and independently adjudicated 12-lead ECG.

Prospective Observational Study of Left Atrial Appendage Measurements Using NuVision 4D Intracardiac Echocardiography From Right-Sided Versus Left-Sided Imaging Windows During Watchman Implantation

NCT Number: To Be Determined

Summary:

A prospective, multisite observational pilot study enrolling 50 adults with atrial fibrillation undergoing Watchman implantation, either as a standalone procedure or together with atrila fibrillation (AF) ablation. The study compares left atrial appendage and post-implant device measurements obtained using NuVision 4D intracardiac echocardiography from right-sided and left-sided imaging windows. By identifying an accurate and potentially simpler ways to guide AF/Watchman procedures, this study may help improve procedural safety and strengthen stroke prevention for patients with atrial fibrillation.

Aim:

• To determine whether right-sided NuVision 4D intracardiac echocardiography provides left atrial appendage measurements comparable to those obtained from left-sided imaging.
• To evaluate the relationship between these measurements, Watchman device-size selection, procedural performance, and post-implant outcomes.

Primary endpoint:

• Agreement between right-sided and left-sided measurements of left atrial appendage anatomy.

Summary:
Using digital health technology to evaluate COVID19 patients’ risk of developing respiratory, cardiovascular, and behavioral events shortly as well as months after improvement of respiratory symptoms is vital. This would help identify patients who may need discharge reconsideration, re-admission or close cardiovascular and/or behavioral follow up initiatives driven by remote monitoring using wearable/mobile health technologies.
Aim:

• Use continuous digital health monitoring to investigate the incidence and predictive factors of early cardiovascular complications related to COVID-19 in all COVID-19 diagnosed patients.
• Determine the long-term impact of COVID-19 on cardiovascular outcomes in in patients diagnosed with COVID-19, including hospitalized and non-hospitalized patients, using continuous digital health monitoring.
• Utilize behavioral health surveys in conjunction with continuous digital health monitoring to screen for common behavioral and mental health disorders in post-COVID19 patients and determine its association with cardiovascular events.
• To evaluate and assess any long-term CV sequelae (cardiac tissue damage/disease) through optional MRI imaging.

Summary:
EDORA is a Phase IV, prospective, investigator-initiated, randomized clinical trial.

This 1-year trial will take place across 14 US sites, enrolling a total of 330 patients (24 patients per site).
All patients will undergo cardiac ablation as part of their treatment plan for atrial fibrillation. Atrial fibrillation (AF) is an irregular rhythm in the heart caused by chaotic electrical pulses affecting the upper chambers (atria) that results in the heart beating rapidly but not efficiently. Thus, it does not allow enough time for the heart to pump blood to the brain or the rest of the body.
When medications alone do not suffice and other complications arise, cardiac ablation is advised. This is a procedure where a scar is made in the area that is allowing the erratic electrical signals to occur and by destroying this piece of tissue it stops the abnormal heart rhythm.

In the EDORA trial, patients who have undergone cardiac ablation will be randomized and blinded to one of two groups; one group will receive dronedarone 400mg twice a day (treatment group) while the other group will receive placebo (sugar pill, control group). Dronedarone (Multaq®) is an FDA approved drug given to treat patients with atrial fibrillation.

The EDORA trial would like to investigate another use for dronedarone. Through imaging (CMR scans) and a wearable ECG monitoring device (BodyGuardian MINI© Plus by Preventice)

Aim:

• Patients on dronedarone will have fewer AF recurrences after cardiac ablation vs patients on placebo. (Evaluated by ECG readings from BodyGuardian MINI© Plus, ECG monitoring device).
• Dronedarone is effective in reducing atrial fibrosis (scarring) after ablation compared to standard of care (drug therapy alone) vs placebo. (Evaluated by 3 CMR imaging scans).

Patients will also be followed up during the trial via monthly telehealth visits, 2 phone calls and 2 online questionnaires to assess their progress, changes in quality of life, AF burden, to monitor for adverse events, and to provide technical assistance for troubleshooting devices.

Summary:

This research hopes to better define the variability of LAA anatomy and orifice geometry in an AF population. Capturing the details of its anatomy would help optimize mechanical antithrombotic therapy in patients with contraindication to anticoagulants.

Aim:

• Evaluate the LAA anatomy and orifice geometry using 3D images generated by CMR in an AF population. LAA orifice geometry metrics will be defined by the shape, surface area, depth, long axis, short axis and eccentricity of the orifice. Its relationship to adjacent structures including the left superior pulmonary vein, will also be assessed.

Summary:

Study will identify individuals with high-risk of embolic stroke using imaging criteria that reflect the underlying pathophysiology of embolic stroke of cardiac origin. LAA has a major contributor to stroke risk and highlight its role in the proposal. Additionally, single non-invasive cardiac imaging modality will be used that can comprehensively assess the LA and LAA in their structure, function, and shape. Study targets non-AF individuals with or without stroke history, paving the way for reforming both primary and secondary stroke prevention strategies. Imaging-defined embolic-appearing stroke outcome will be used , including both covert and symptomatic strokes. Given that covert strokes have been strongly associated with a decline in cognitive function study indirectly provide a path for novel approaches to prevent vascular cognitive impairment.

Aim:

• Investigate the association between imaging markers of LA and LAA pathology and imaging-defined embolic-appearing strokes in individuals with no history of AF and develop an imaging stroke risk assessment score capable of predicting embolic strokes in this population.
• Evaluate the prevalence of high-risk LA and LAA imaging features in patients with no history of AF.

Summary:

Study Objective(s): To establish the safety and effectiveness of the Boston Scientific Cardiac Cryoablation System for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial fibrillation (AF). Multi-center, open label, prospective, single arm study to document the safety and performance of Boston Scientific’s Cryoablation System. All subjects fitting the enrollment criteria, signing the consent and undergoing the index procedure with the study devices will be followed up for twelve (12) months after the index procedure

Summary:

The clinical study is a prospective, single-arm, multi-center, open-label, controlled, pre-market, study designed to provide safety and efficacy data regarding the use of the Adagio System in the treatment of persistent atrial fibrillation. For the purposes of this study, PsAF is defined as continuous AF that is sustained beyond seven (7)days but no more than12-months.

PRIMARY OBJECTIVE:

To determine whether there is valid scientific evidence that endocardial ablation using the FARAPULSE Pulsed Field Ablation System is both safe and effective for treating drug resistant symptomatic PAF

PRIMARY CLINICAL HYPOTHESIS:

Pulmonary vein isolation (PVI) created by the FARAPULSE Pulsed Field Ablation System is not inferior in safety and effectiveness to treatment with approved catheter ablation technologies – force-sensing radiofrequency ablation (RFA) or cryoballoon ablation (CBA) – in the treatment of drug-resistant symptomatic PAF

Summary:

A prospective, randomized, multi-center trial of patients with persistent AF and the prescence of atrial fibrosis.

Aim:

• To examine the efficacy of targeting atrial fibrosis tissue during an ablation procedure in treating persistent AF.

Primary endpoint:

• The recurrence of atrial arrhythmia post-ablation.

Summary:

COAG-AF is a 3-month prospective observational study in patients diagnosed with atrial fibrillation and undergoing a first-time ablation procedure. It will be a pilot study consisting of approximately twenty patients.

The aim of the COAG-AF study is to prove that an increase in pro-thrombotic biomarkers in AF is associated with an increase in AF burden.

Secondary objectives of the study are the following:

• To investigate the impact of catheter ablation on serum pro-thrombotic biomarkers in patients with AF.
• To correlate coagulation biomarkers with imaging features such as, the degree of fibrosis found on Late Gadolinium Enhancement MRI (LGE-MRI) scans, which is a part of standard of care.
• To determine baseline values of coagulation and pro-thrombotic biomarkers in the AF population and compare those baseline values with the general population values.
• To compare central and peripheral thrombotic biomarkers in patients with atrial fibrillation.

Aim:

• The first aim of this project is to determine how admissions for heart failure, atrial fibrillation, and myocardial infarction have been impacted by the pandemic.
• The second is to determine whether demographics, such as race, ethnicity, and age, are associated with disproportionate changes in admissions for these conditions.
• The final aim is to assess whether management and outcomes for these conditions has been impacted since the onset of the pandemic.