Clinical Research Studies

NCT Number: NCT04605965

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.

NCT Number: NCT4704050

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.

NCT Number: NCT04703166

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

TiPP is a prospective, investigator-lead cohort study.
This 1-year study will take place across 5 US sites, enrolling a total of 300 participants (60 participants per site). Enrolled participants will either have been diagnosed with atrial fibrillation (AF) or have moderate-high risk factors for developing AF.

Atrial myopathy is a newly termed disease that describes dysfunction in the muscle of the upper chambers of your heart (atria). It is generally caused by aging, inflammation, oxidative stress and stretching of the atria. Atrial myopathy can act as a precursor to various heart conditions, including AF.

The objective of this study is to evaluate the progression of atrial myopathy in participants by using wearable devices (Samsung© Galaxy Watch Active 2 and Preventice© BodyGuardian MINI Plus, ECG monitoring device) and through cardiac magnetic resonance imaging (CMR).

Aim:

• Investigate the association between daily biometric data and the extent of atrial myopathy, its progression and cardiovascular outcomes using CMR and Samsung’s Galaxy Watch Active 2.
  Through Samsung’s wearable device we can collect an array of data; photoplethysmography (PPG) waveforms that measure fluid volume changes in blood vessels, heart rate, heart rate variability, step counts, oxygen saturation levels and sleep patterns and quality.
  Participants will upload their daily watch data onto a smartphone application provided by Samsung (Galaxy S9 phone).
• Perform CMR scans to visualize atrial fibrosis (scarring) at the beginning of the study and compare it to any changes seen over a 1-year period. We will be analyzing the extent of fibrosis and changes in the shape and function of the atria.
• Collect and analyze ECG readings recorded by BodyGuardian MINI Plus in order to compare and contrast it to recorded PPG waveforms. This data will be used to train a machine learning concept (via continuous tachogram) to predict atrial myopathy and major cardiovascular outcomes, leading to earlier preventive interventions.

Participants will also be followed up during the study via phone calls to assess their progress, to monitor for AF events and to provide technical assistance for troubleshooting devices.

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.

NCT Number: NCT04814420

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

NCT Number: Not Submitted

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.

NCT Number: NCT04769310

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.

NCT Number: NCT04133168

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

NCT Number: NCT04061603

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.

NCT Number: Pending

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

NCT Number: NCT02529319

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.

NCT Number: Not Submitted

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: Pending

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.

NCT Number: Not Submitted

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.

NCT Number: Not Submitted

Summary:

Prospective, observational cohort, pilot study.

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.

NCT Number: Not Submitted

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.