Clinical Research Directory

Safety and Effectiveness of Short-Term Single AntiPlatelet Therapy After Left Atrial Appendage Closure With the LAmbre Device in Patients With Nonvalvular Atrial Fibrillation: A Multinational Real-world Registry

Brief Summary: A prospective, multicenter, single-arm, non-randomized study including consecutive patients with nonvalvular AF(Atrial Fibrillation), with a CHA2DS2-VASc score ≥2 (men) or ≥3 (women), and contraindication for long-term anticoagulant treatment, with successful LAAC (Left Atrial Appendage Closure)procedure with the LAmbre device, who at discharge are eligible for short-term (3-months-only) SAPT. We want to assess if a short-term single antiplatelet therapeutic regime of Acetylsalicylic acid (ASA) 100 mg (or clopidogrel 75 mg if ASA contraindication), once daily, for 3 months is safe and effective at 12 months follow-up.

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.

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.

Clinical Implication of Atrial Fibrillation Detection Using Wearable Device in Patients With Cryptogenic Stroke

Atrial fibrillation (AF) detected after ischemic stroke has immediate therapeutic implications, because it prompts a switch from antiplatelet to anticoagulant therapy. The conventional method used to screen for AF in patients whose stroke has no identified cause (cryptogenic stroke) is 24-hour Holter monitoring. CANDLE-AF is a multicenter, open-label, randomized trial comparing three noninvasive monitoring strategies over 12 months in patients with cryptogenic ischemic stroke or transient ischemic attack and no known AF: physician-directed standard care (at least one 24- to 72-hour Holter recording), scheduled 72-hour single-lead patch ECG monitoring repeated at 1, 3, 6, and 12 months, and twice-daily 30-second handheld single-lead ECG recording with a smartphone-based device for 12 months. The primary outcome is detection of AF lasting 30 seconds or longer within 12 months.

SIMPLAAFY Clinical Trial

The primary objective is to demonstrate the safety and effectiveness of two monotherapy regimens versus dual antiplatelet (DAPT) therapy following post-implant with the WATCHMAN FLX Pro device in a commercial clinical setting.

Realtime Diagnosis From Electrocardiogram Artificial Intelligence-Guided Screening for Atrial Fibrillation With Long Follow-Up (REGAL)

The purpose of this research is to test whether Apple Watch, used as a long-term monitoring device, can enable early detection of atrial fibrillation.

Renal Denervation + PVI vs PVI Alone for Persistent AF

Pulmonary vein isolation (PVI) is the cornerstone of ablation for atrial fibrillation (AF). Increased cardiac sympathetic stimulation can facilitate AF and reduction can be accomplished by renal artery denervation (RDN). The recently completed randomized trial, ERADICATE-AF, convincingly demonstrated that RDN plus PVI resulted in a reduction in recurrent incident AF for uncontrolled hypertensives. This is a randomized controlled pilot trial, "To Evaluate Renal Artery Denervation in Addition to Catheter Ablation to Eliminate Atrial Fibrillation" (ERADICATE-AF II) to test if RDN plus PVI enhances long-term efficacy vs PVI for persistent AF patients with controlled or without hypertension using implantable loop recordings.

To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access.

The purpose of this study is to compare and assess efficacy and safety between the study device "TS-RF system consisting of a electrosurgical system, general-purpose (TS-RF Generator) and a electrosurgical system electrode, hand-controlled, general-purpose, single-use (TS-RF Needle)" and the control device "needle, puncture, single-use (BRK Transseptal needle)", both of which are used for the transseptal puncture performed to enable left atrial access for the treatment of symptomatic arrhythmia and mitral stenosis and then to demonstrate that the study device is non-inferior to the control device.

Affera Global Registry

The Affera Global Registry is a prospective, global, multi-center, observational post-market registry (PMR). The purpose of this study is to describe clinical performance and safety data in a broad patient population treated with the Affera Platform.

ReVeRA-301: Etripamil in Atrial Fibrillation Phase 3

This is a multi-national, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of etripamil NS in patients with atrial fibrillation (AF). This study includes Screening Visit, Randomization Visit, a Treatment Period with scheduled Follow-up Visits (Monthly Follow-up and Post-treatment Follow-up Visits), a Final Study Visit, and an End of Study Telephone Follow up Visit. Each patient will be randomized 1:1 to receive placebo or 70 mg Etripamil NS regimens. Patients will self-administer study drug for a perceived episode of AF with RVR with an initial dose of placebo or 70 mg etripamil NS, followed by an optional second dose of the same study drug 10 minutes after the first dose if the patient continues to experience symptoms. Patients may treat up to a maximum of 4 episodes in the study. Informed consent will be obtained prior to any study procedures.

A Village Doctor-led Telehealth Supported Trial of Heart Failure Prevention in AF Patients: MIRACLE-AF 2 (Heart Failure Prevention)

This cluster randomized study aims to compare village doctor-led integrated care versus usual care to improve cardiovascular health, atrial fibrillation management, self-management adherence, and heart failure prevention among older rural patients with atrial fibrillation in China.The primary outcome at 12 months is the change in Life's Essential 8 cardiovascular health score from baseline (phase 1). The primary outcome at 36 months is a composite cardiovascular endpoint including cardiovascular death, ischemic or hemorrhagic stroke, hospitalization for worsening HF or acute coronary syndrome, and emergency department visits due to AF (phase 2) . The primary outcome at 48 months is new-incident heart-failure diagnosis (phase 3) .An extended observational follow-up, the new-incident heart-failure diagnosis observational follow-up study, will be conducted at Year 7 to evaluate long-term effects.

A Village Doctor-led Telehealth Supported Improvement of Outcomes of AF Patients With Heart Failure Due to Reduced or Preserved Ejection Fraction: The MIRACLE-AF 2 Heart Failure Management Trial (MIRACLE AF-HF)

The primary objective is to determine whether a telemedicine-supported, village doctor-led integrated management model, AF-HF comorbidity ABC pathway and enhanced patient education, improves clinical outcomes compared with usual care among rural residents aged 65-80 years with AF and HF. The trial will evaluate whether integrated management reduces the MAGGIC HF risk score at 12 months (phase 1) and whether it reduces a composite cardiovascular endpoint, including cardiovascular death, ischemic or hemorrhagic stroke, hospitalization for worsening heart failure or acute coronary syndrome, and emergency visits due to atrial fibrillation over 36 months (phase 2). An extended observational follow-up, the composite cardiovascular endpoint observational follow-up study, will be conducted at Year 6 to evaluate long-term effects.

PaTH Clinical Data Research Network (CDRN) Atrial Fibrillation (AF) Clinician-Patient Partnership Cohort

The purpose of the PaTH Network AF Clinician-Patient Partnership Cohort is to use clinical data from electronic health records (EHR) and patient reported outcomes (PRO) to answer questions of clinical importance to patients, providers, and other stakeholders.

A Study to Test How Well BAY 3670549 Works and How Safe it is in Patients With Atrial Fibrillation

The main goal of this study is to find out how well BAY 3670549 works, how safe it is, how well people can tolerate it, and how the body handles the medicine. The study will compare BAY 3670549 to a placebo (a dummy treatment with no active medicine) in people with AF who need a treatment called electrical cardioversion. Electrical cardioversion is a procedure that helps the heart return to a normal rhythm. In this study, each participant will get a single intravenous (IV) infusion of either BAY 3670549 or a placebo. Participants will then be observed to see whether the heart rhythm returns to a normal rhythm. If it does not, electrical cardioversion can still be performed as planned. The study will look at how many participants return from AF to a normal rhythm, without needing electrical cardioversion and how long it takes. It will also show how many participants experience medical problems after treatment and how BAY 3670549 move into, through and out of the participants' body. The total duration of the study for an individual participant may be up two months. The findings from this study may contribute to the development of a new treatment option for people with AF.

PULSed Field Ablation for Atrial Fibrillation Using a Balloon for Early Intervention - Study

This study is a prospective, multicenter, randomized, open-label, blinded end-point, controlled clinical trial to investigate the impact of first line pulsed field ablation during 12 months follow-up in patients with early-stage paroxysmal or persistent atrial fibrillation (\<3 years) compared to usual care, defined as OMT.

Surgical Ablation of AF Efficacy Trial

SAFE is an international multicentre RCT of concomitant surgical atrial fibrillation (AF) ablation in patients with paroxysmal or persistent AF undergoing cardiac surgery.

Left-atrial Fibrosis in Persistent Atrial Fibrillation and Its Comorbidities

Pulmonary vein isolation is an established intervention for atrial fibrillation. Patients with a paroxysmal atrial fibrillation have no or only few comorbidities and a good prognosis in respect to their atrial fibrillation. In contrast, patients with persistent atrial fibrillation often suffer from relevant comorbidities and recurrence of atrial fibrillation is common. Left-atrial fibrosis and its electrophysiological consequences are involved in the recurrence rate, but pathophysiological mechanisms are yet to be better characterized. The study investigates relevant comorbidities to elucidated their effect on atrial fibrosis and recurrence rates of atrial fibrillation. Furthermore, the investigators evaluate the prevalence of these comorbidities.

Volunteers to Investigate Best Results for Ablation and Novel Therapies for Atrial Fibrillation

VIBRANT-AF seeks to: * Identify clinically relevant predictors of effectiveness and complications of AF ablation procedures in a prospective, US-based, multi-center, real-world longitudinal study * Assess changes in modifiable lifestyle-related exposures influence the effectiveness of AF ablation * Determine incidence and predictors of complications of AF ablation procedures Participants will connect with the Eureka Research Platform and answer a series of surveys and activities over a one-year period. They will be asked about lifestyle habits, recurrence of AFib, hospitalizations, and general feelings and emotions.

Hypertension and Arrhythmias in CLL Patients Treated With BTK Inhibitors

Acalabrutinib and Zanabrutinib are highly effective drugs used to treat Chronic Lymphocytic Leukemia, but they are associated with high blood pressure and abnormal heart rhythms. SENTINEL is an observational study that will use wearable technology to monitor heart rhythm and blood pressures at home to better understand how frequently patients are experiencing high blood pressure and/or abnormal heart rhythms.

Future Innovations in Novel Detection for Atrial Fibrillation (FIND-AF): Pilot Study

The purpose of this study is to trial a new intervention - risk-guided AF screening using an EHR-based risk score and remote ECG monitoring process - and to characterise individuals at elevated predicted AF risk.

COmparison of Bleeding Risk Between Rivaroxaban and Apixaban in Patients With Atrial Fibrillation

Atrial Fibrillation (AF) affects 200,000 Canadians and increases risk of stroke, morbidity and mortality. Having a stroke can affect a patient's ability to speak, eat, walk, work, care for themselves, and interact with others. Not only can it ruin one's life, but it can also be fatal. A stroke occurs when blood flow to the brain is blocked by a clot, depriving brain cells of oxygen. In people with atrial fibrillation, blood flow is sluggish in the top chambers of the heart, and blood clots can form there. When a piece of a clot breaks off, it can travel to the brain and cause a stroke. That's where blood thinners come in. Blood thinners, or anticoagulants, decrease the chances of blood clots forming in the heart, reducing the risk of stroke. Studies show that blood thinners are highly effective at reducing the risk of stroke by up to 95%. The conventional blood thinner is warfarin, taken by mouth. Warfarin requires regular blood tests to make sure a patient getting the correct dose. The patient also may have to avoid certain foods since the medication can interact with them. Newer blood thinners, known as direct-oral anticoagulants (DOACs) are available, which do not require regular blood tests and do not interact with foods. Two of the new blood thinners are called rivaroxaban and apixaban. Like warfarin, they can be taken by mouth, and studies have shown them to be as effective as warfarin. Both rivaroxaban and apixaban have been approved for stroke prevention in AF by Health Canada. However, there have been no direct head-to-head comparisons of these two anticoagulants, meaning comparative safety data is not available. Increasing use of DOACs for stroke prevention in AF and patient values around bleeding highlight the need for a comparison trial to ensure patients receive the anticoagulant with the greatest balance of benefit to potential harm. The trial is to assess bleeding rates and superiority of using apixaban versus rivaroxaban in patients with non-valvular atrial fibrillation.

pCAD-POAF 3 Year Follow-up

This study will include the subjects who enrolled in pCAD-POAF trial (NCT05009914) to observe clinical outcomes 3 years after surgery. The primary outcome is the time to first occurrence of a composite of all-cause death, stroke, systemic embolism, myocardial infarction, unplanned cardiac rehospitalization, or post-discharge atrial fibrillation from randomization through 3 years after surgery. The secondary outcomes are：the individual components of the primary composite outcome; unplanned all-cause rehospitalization; arrhythmias other than atrial fibrillation; premature atrial contraction and premature ventricular contraction burdens; heart rate variability parameters; quality-of-life scores; and other Holter-derived parameters.

DUTCH Weight Control in Atrial Fibrillation Study

Quantify the effect of an innovative weight loss management on rhythm control.

CASTLE-HFpEF (Catheter Ablation for Atrial Fibrillation Patients With Heart Failure With Mildly Reduced and Preserved Ejection Fraction)

The clinical equipoise in the treatment of Atrial Fibrillation (AF) in patients with Heart Failure with mildly reduced Ejection Fraction/Heart Failure with Preserved Ejection Fraction (HFmrEF/HFpEF) reflects the scarcity of randomized trials on different treatment modalities. By generating high-quality, evidence-based, randomized data on the impact of treatment on hard outcomes, Catheter Ablation Versus Standard Conventional Treatment in Atrial Fibrillation Patients with Heart Failure with Preserved Ejection Fraction (CASTLE-HFpEF) will provide clinical decision-making guidance and help physicians in the management of patients with HFmrEF/HFpEF and AF. The main hypothesis is that Catheter Ablation (CA) for AF is associated with improved clinical outcomes in patients with HFmrEF/HFpEF and AF compared to medical AF treatment strategies on top of optimal medical HF treatment. CASTLE-HFpEF aims to study these hard clinical outcomes in a randomized cohort of patients with AF and HFmrEF/HFpEF.