Clinical Research Directory

CHAMPION-AF Clinical Trial

The primary objective of this study is to determine if left atrial appendage closure (LAAC) with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation.

Comparing the Safety and Efficacy of Apixaban and Rivaroxaban

* The trial will compare two anticoagulants ("blood thinners") that are currently used in the VA and are considered standard care to prevent strokes in patients with atrial fibrillation. The two most commonly-used anticoagulants will be compared: apixaban (Eliquis) and rivaroxaban (Xarelto). They are considered by many doctors to have similar benefits and risks, but no one knows for sure. * The trial only enrolls patients with a diagnosis of atrial fibrillation ("A Fib") or atrial flutter. Most participants will be age 65 or older, and should already be taking apixaban or rivaroxaban. * The investigators will measure, in about 10,000 VA patients nationally, whether the rates of stroke, major bleeding, or death differ between these two drugs. * The trial will last about 7 years, but after the first prescription, all information will be collected from electronic medical records.

Pharmacological Intervention to Prevent NOAF After TAVR

The goal of this clinical trial is to learn if amiodarone or metoprolol works to prevent new-onset atrial fibrillation (AF) in patients who develop certain atrial arrhythmias after transcatheter aortic valve replacement (TAVR). It will also learn about the safety of these drugs. The main questions it aims to answer are: * Do amiodarone or metoprolol reduce the incidence of new-onset AF within 90 days after TAVR? * What medical problems do participants have when taking amiodarone or metoprolol? Researchers will compare amiodarone and metoprolol to observation (no antiarrhythmic drug) to see if either drug reduces the development of new-onset AF. Participants who meet the post-TAVR arrhythmia criteria will: * Be randomly assigned to receive amiodarone, metoprolol, or observation * Take the assigned drug (if applicable) according to a specified dosing regimen * Be monitored continuously during hospitalization and undergo follow-up assessments at 30, 60, and 90 days, including ECGs, Holter monitors, and laboratory tests

Carotid Implants for PreveNtion of STrokE ReCurrEnce From Large Vessel Occlusion in Atrial Fibrillation Patients Treated With Oral Anticoagulation

Patients with atrial fibrillation (AF) who have had a prior stroke are at very high risk of recurrent ischemic stroke. About 40% of these strokes are due to large emboli which result in large cerebral vessel occlusion (LVO). This randomized control trial aims to address this unmet need by testing whether use of bilateral carotid filter implants in addition to OAC will reduce the risk of stroke in AF patients with recent (e.g. within 12 months) ischemic stroke vs. only OAC.

The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation

REACT-AF is a multicenter prospective, randomized, open-label, blinded endpoint (PROBE design), controlled trial comparing the current Standard Of Care (SOC) of continuous Direct Oral Anticoagulation (DOAC) use versus time-delimited (1 month) DOAC guided by an AF-sensing Smart Watch (AFSW) in participants with a history of paroxysmal or persistent Atrial Fibrillation (AF) and low-to-moderate stroke risk.

A Study to Select the Dose and Evaluate the Effectiveness and Safety of the Drug Refralon®, Tablets, 1 mg for Long-term Use to Prevent Recurrence of Atrial Fibrillation/Flutter After Terminating Its Persistent Form

Refralon® tablets in two different doses (1 or 2 tablets per day) will be evaluated vs. placebo in patients with persistent atrial fibrillation/flutter after synus rhythm restoration in order to prevent recurrence of arrhythmia. Efficacy and safety of Refralon® tablets will be studied, its optimal dose will be selected and its pharmacokinetics will be evaluated in 14 days, 1, 3 and 6 months.

BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF

This study is designed to obtain real-world clinical evidence on the safety and effectiveness of the Volt PFA System in various use cases, with a sub study designed to address additional clinical evidence needs in electrophysiology.

Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy

Atrial fibrillation (AF) is one of the most common cardiac arrhythmias and cardioembolic stroke due to AF is its major complication. Direct oral anticoagulants (DOAC) reduce the risk of cardioembolism in patients with AF. Despite DOAC therapy, there is a significant residual stroke risk of 1-2%/year. Recent data from the Swiss Stroke Registry found 38% of patients with AF and ischemic stroke were on prior anticoagulant therapy (approximately 400 patients per year in Switzerland). The investigators found in a prior observational study, that patients with AF who have ischemic stroke despite anticoagulation are at increased risk of having another ischemic stroke (HR 1.6; 95% confidence interval, CI 1.1-2.1). Combining observational data from 11 international stroke centres, the investigators found that the majority of ischemic strokes despite anticoagulation in patients with AF is "breakthrough" cardioembolism (76% of patients) and only a minority of 24% is related to other causes unrelated to AF. Optimal secondary prevention strategy is unknown. The investigators have conducted two independent observational studies including together \>4000 patients but did not identify any strategy (e.g. switch to different DOAC, additional antiplatelet therapy) that seems superior. A recent randomized controlled trial on surgical occlusion of the left atrial appendage (LAAO) found that LAAO may provide additional protection from ischaemic stroke in addition to oral anticoagulation. Triggered by this finding, the investigators performed a matched retrospective observational study and found that patients with AF and stroke despite anticoagulation who received a combined mechanical-pharmacological therapy (DOAC therapy + LAAO) had lower rates of adverse outcomes compared to those with DOAC therapy alone. Therefore, the investigators hypothesize that in patients with AF and ischemic stroke despite anticoagulant therapy, LAAO in addition to anticoagulation with a DOAC is superior to DOAC therapy alone. The investigators propose an international, multi-center randomized controlled two-arm trial to assess the effect of LAAO in patients with AF suffering from strokes despite anticoagulation therapy and without competing stroke etiology. The investigators will use the PROBE design with blinded endpoint assessment. The investigators will enrol patients with non-valvular AF and a recent ischemic stroke despite anticoagulation therapy at stroke onset. Patients will be randomized 1:1 to receive LAAO + DOAC therapy (experimental arm) or DOAC therapy alone (standard treatment arm). The primary endpoint is the first occurrence of a composite outcome of recurrent ischemic stroke, systemic embolism and cardiovascular death during follow-up. Secondary outcomes include individual components of the primary composite outcome, safety outcomes (i.e. symptomatic intracranial haemorrhage, major extracranial bleeding, serious device- or procedure-related complication), functional outcome (modified Rankin Scale) and patient-oriented outcomes. The minimum follow-up is 6 months and all patients will receive follow-ups every 6 months until end of study, the maximal follow-up will be 48 months. Based on prior observational data from the investigators' group and others (5 observational studies, \>5000 patients), the investigators estimate the proportion of patients with the primary outcome in the standard treatment arm to be 18% in the first year and 9% in the second year (=cumulative 27% after 2 years). A relative risk reduction of 40% at 2 years would be clinically relevant. Based on these assumptions and a log-rank test, the investigators would need 98 events for a power of 80% at an alpha-level of 5%. Assuming a recruitment rate of 52, 118, 156 and 156 patients in years 1 to 4, an additional 6 months of follow-up (mean follow-up time of 2.1 years) and a uniform drop-out rate of 7.5% per year, 482 patients would need to be enrolled. How to treat patients with an ischemic stroke despite anticoagulation is a major yet unresolved clinical dilemma. This trial has the potential to answer the question whether LAAO plus DOAC therapy is superior to current standard of care for patients with AF who have ischemic stroke despite anticoagulation.

PROSPective Evaluation of Outcome After CatheTer Ablation in Atrial Fibrillation

Atrial fibrillation ablation is the most common intervention performed worldwide. Up to 20 to 45% of patients show recurrence of AF within 12 month after catheter ablation, however its determinant are incompletely understood. The aim of the PROSPECT-AF study is to assess the predictors of AF recurrence within the 3 years following ablation using clinical variables and innovative biomarkers in a prospective cohort of 750 patients undergoing atrial fibrillation catheter ablation. The secondary aims are to assess the incidence of major adverse cardiovascular outcomes (MACE) and the incidence of major bleeding within the 3 years Wolfing catheter ablation.

Avoiding Anticoagulation After IntraCerebral Haemorrhage

Randomised controlled trials (RCTs) demonstrate a substantial benefit from oral anticoagulant drugs for the prevention of stroke and systemic embolism in non-valvular atrial fibrillation (AF). However, these RCTs excluded patients with prior intracerebral haemorrhage (ICH). Therefore, guidelines are unable to recommend whether oral anticoagulant drugs, in particular non-vitamin K antagonist (called direct OAC) - can be used for patients with AF after an intracerebral haemorrhage. Roughly 30% of adults with ICH have AF but in 2017 it remains unclear whether they should start oral anticoagulant drugs, be treated with left atrial appendage closure (LAAC) or avoid anticoagulation and LAAC.

Lesion Formation With Pulsed Field Versus Cryobaloon Ablation as Assessed by Cardiac Magnetic Resoncance

This randomised study will compare pulsed field ablation and cryoballoon ablation with respect to ablation lesion quality as assessed by late gadolinium enhancement (LGE) cardiac magnetic resonance (CMR) at 3 months post-ablation. Patients scheduled for first-time AF ablation will be randomised in a 2:1 fashion to receive PVI-only, either by pulsed field ablation (Farapulse Pulsed Field Ablation System, Boston Scientific) or cryoballoon ablation (Medtronic Cryoballoon Ablation System).

A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation

The main purpose of the study is to assess how well the standard ablation procedure (Varipulse Catheter) works over long term when used with different types of anesthesia in participants with symptomatic paroxysmal atrial fibrillation (PAF, irregular heartbeat that comes and goes on its own, causing noticeable symptoms like a racing heart, or shortness of breath).

A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF

The main purpose of this study is to investigate the workflow of the clinical use of the pulsed field (PF) ablation system (VARIPULSE catheter and TRUPULSE generator) when used for cardiac ablation with the new VARIPULSE Pro software in participants with paroxysmal atrial fibrillation (PAF; irregular heartbeat where episodes start and stop on their own, usually within seven days, often resolving within 24-48 hours, though sometimes lasting up to a week) and persistent atrial fibrillation (PsAF; irregular, rapid heartbeat that lasts over 7 days and doesn't stop on its own).

Realistic Computational Electrophysiology Simulations for the Targetted Treatment of Atrial Fibrillation

The aim of this research is to classify patients by the dominant mechanism of continuous atrial electrical activation during atrial fibrillation. This approach seeks to improve on existing classifications which are based solely on the duration of the arrhythmia (\<7 days, \>7 days and \>1 year). This is a cohort study. Patients undergoing clinically indicated electrophysiology study or AF ablation will have invasive assessment of cardiac electrophysiological profile at the time of their planned procedure, undergo 2-week ambulatory monitoring before and after the procedure, complete symptom questionnaires before and after their procedure and undergo atrial cardiac magnetic resonance imaging before their procedure.

Peer-Mentor Support for Vulnerable Patients With Atrial Fibrillation

The goal of this randomized clinical trial is to evaluate whether a peer-mentor intervention can improve mental well-being among vulnerable patients with atrial fibrillation (AF). Patients with AF often experience anxiety, uncertainty, and reduced quality of life. These challenges are particularly pronounced among individuals with low socioeconomic position, who may face additional barriers to accessing supportive care. The main question the study aims to answer is: Does a 16-week peer-mentor intervention reduce anxiety symptoms among patients with AF compared with usual care? Researchers will compare peer-mentor support plus usual care with usual care alone. Participants will: Complete questionnaires about anxiety, depressive symptoms, quality of life, and self-efficacy at baseline and after 16 weeks. Be randomized either to receive peer-mentor support for 16 weeks or to receive usual care only. If allocated to the intervention group, be matched with a trained peer mentor with lived experience of atrial fibrillation who provides emotional support and practical guidance through approximately eight contacts over the 16-week period. The study will also include follow-up using national health registers and a mixed-methods process evaluation exploring participants' and mentors' experiences with the intervention.

A Behavioural Weight Loss Intervention Delivered in Cardiac Rehabilitation for Patients With Atrial Fibrillation and Obesity

One-in-four Canadians will be diagnosed with an abnormal heart rhythm called atrial fibrillation (AF) in their lifetime. This is expected to double by 2050, owing to an aging population and increased age- and health behaviour-associated AF risk factors (e.g., poor cardiorespiratory fitness, Type II diabetes, hypertension, and obesity). AF is associated with an increased risk of severe health outcomes including stroke, heart failure, dementia, and death. Nearly three-quarters of people with AF also have obesity (excess body weight). According to research, people with obesity that lose approximately 10% of their body weight can experience relief from uncomfortable AF symptoms. Losing weight may even help people return to a normal heart rhythm. Cardiac rehabilitation (CR) is a proven way to help people with heart disease live longer, healthier lives. So far, research has not shown whether CR helps improve the abnormal heart rhythms seen in AF. This may be because CR programs usually do not offer specific help with weight management. Therefore, adding behavioural weight-loss treatment (BWLT; group classes to change thoughts and behaviours to encourage weight loss) to CR programs may help people with AF and obesity experience relief from their symptoms. This randomized controlled trial will assess whether the combination of an AF-specific 'small changes' BWLT and traditional CR results in a greater proportion of patients with AF and obesity achieving ≥ 10% body weight loss compared to patients who receive standard care (traditional CR alone). Traditional CR consists of participating in exercise sessions, supervised by health professionals, twice per week for 12 weeks. In addition to traditional CR, patients that are randomized to receive BWLT will attend 12 weekly online group therapy classes to learn strategies from psychology to help encourage weight loss. The investigators will collect data pertaining to weight, AF burden, physical activity, and disease-specific and generic patient-reported outcomes. This information will determine if taking CR+BWLT helps patients with weight loss and AF symptoms. Further, it will help efforts to provide effective treatment to patients with AF to help participants lose weight and reduce or eliminate AF symptoms.

Dapagliflozin in Patients With Atrial Fibrillation (DAPA-AF)

The study will investigate the effect of Dapagliflozin on atrial fibrillation (AF) burden. AF burden will be defined as the percent of time spent in AF over a 2-week period, assessed by noninvasive continuous heart rhythm monitoring at baseline and at 3 months, quality of life (QOL) and validated echocardiographic indices of atrial myopathy. This knowledge will enable us to study the therapeutic potential of SGLT2i as a novel adjunct treatment for patients with DM and AF. Patients with paroxysmal AF (AF that terminates spontaneously or with intervention within seven days of onset) and DM and randomize them to Dapagliflozin or placebo. Continuous heart rhythm monitoring patch for AF burden will be used, measure of QOL with the help of AF Effect on Quality-of-life survey and perform an echocardiogram with measurement of left atrial volume index, left atrial strain and atrial tissue dopplers. All measurements will be performed at baseline and at study completion. The central hypothesis is that SGLT2i will lead to reduced AF burden that will translate into improvement in QOL, and the underlying mechanism is improvement in atrial myopathy.

Feasibility Study of the FARAFLEX Mapping and PFA System

The objective of this feasibility study is to evaluate the safety and effectiveness of the FARAFLEX mapping and pulsed field ablation (PFA) catheter, a novel catheter in treating persistent atrial fibrillation (PersAF) or symptomatic Paroxysmal Atrial Fibrillation (PAF).

HeartBeam ECG Registry

The HeartBeam ECG Registry will collect ECG recordings acquired with the HeartBeam System with relevant clinical information in clinical settings.

Supporting Use of AC Through Provider Profiling of Oral AC Therapy for AF IV

Six million Americans live with atrial fibrillation (AF), a heart rhythm abnormality that is a major risk factor for stroke and only half of those AF patients receive oral anticoagulation (AC). Within the context of an ongoing collaboration between two large learning health systems, the investigators propose to study the impact of a shared clinical decision support tool embedded within the electronic health record designed to enhance guideline-based AC prescription. The hypothesis the investigators are testing is that the number of AC starts in patients seen by intervention providers will be higher than in patients seen by control providers. Additionally, the investigators are testing the hypothesis that the risk of not persisting on AC will be higher in the patients of control providers compared with patients of intervention providers.

cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia

Subjects enrolled in the OPTION-A study will be clinically indicated for atrial fibrillation (AF) ablation procedure with the FARAPULSE™ PFA system and treatment with WATCHMAN LAAC Device, per physician's medical judgement and according to hospitals' standard of care during the same procedure.

PULSED AF Post-Approval Study

PULSED AF PAS is a prospective, global, multi-center, non-randomized, observational trial. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months.

The Vanderbilt Atrial Fibrillation Ablation Registry

The Vanderbilt Atrial Fibrillation Ablation registry (VAFAR) is a prospective clinical and genetic biorepository that systematically enrolls patients undergoing atrial fibrillation (AF) ablation. The registry was started in 2011 and has greater than 1000 AF ablation records with stored blood and DNA samples. The goals of VAFAR are to: 1) identify clinical, genetic, and serological predictors of response to AF ablation in order to improve patient selection, and 2) to provide a resource for translational research investigating the electrophysiologic mechanisms of AF pathogenesis.

Telemedicine-based Integrated Management of Atrial Fibrillation and Heart Failure in Older Patients in Village Clinics

The goal of this cluster-randomized clinical trial is to evaluate a telemedicine-based, village doctor-led integrated management program for older adults (aged 65-80 years) who have both atrial fibrillation (AF) and heart failure (HF) in rural clinics in China. It aims to answer whether the digitally-supported program improves heart failure prognosis, assessed by the MAGGIC score, at 12 months , and reduces the risk of composite endpoint events, such as cardiovascular death, stroke, or heart failure hospitalization, over 36 months compared to conventional routine care. In this study, village clinics will be randomly assigned to either the intervention group or the control group. Participants in the control group will receive conventional routine care and basic public health services , while participants in the intervention group will receive a comprehensive management program led by village doctors. This intervention includes optimized medication treatment guided by a digital health platform with remote expert support , as well as a structured multidimensional lifestyle intervention featuring peer-support group exercises, smart wearable device monitoring, and personalized health education.