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553 active trials for Atrial Fibrillation

Minocycline Plus Amiodarone Versus Amiodarone Alone for the Prevention of Atrial Fibrillation After Cardiac Surgery

. New- onset postoperative atrial fibrillation (POAF) is a common complication after cardiac surgery and its occurrence increases with age. POAF can result in clinically significant morbidity and mortality. The national trend in the US is that the population older than 65 years is increasing, making healthcare expenditure related to POAF to be a major burden on health care system. Effective treatment of POAF is imperative in ensuring quality of care and reduction of costs. In 2021 there is a projected total of 377,763 cardiovascular surgeries in the US alone with approximately half of which will have POAF with longer postoperative length of stay (+3.9 days) and higher discharge costs (+$13,993) than no-POAF patients (Reference: Ann Thorac Surg. 2015 Jan;99(1):109-14). Amiodarone, the currently used therapy, is often insufficient to prevent POAF and has multiple side-effects. In this study, we expect to improve the incidence of POAF by using a common acne drug (Minocycline) that is safe and that could be incorporated in clinical care of this disease.

Start: February 2023

Cardiovascular Risk Reduction in Atrial Fibrillation Trial

Atrial fibrillation (AF) is a serious public health problem because of its increasing incidence and prevalence in the aging population. AF is associated with elevated risks of death, stroke, coronary event, heart failure, cognitive decline, and chronic kidney disease. To identify preventive interventions for major cardiovascular events beyond effective anticoagulation should be a major priority in the treatment of AF patients. The CRAFT study is a 2-arm, multicenter, randomized clinical trial designed to test whether intensive blood pressure control will reduce the risk of major cardiovascular events in AF patients.

Start: August 2020

STrategies for Catheter Ablation of peRsistent Atrial Fibrlllation

The objective of this study is to compare the efficacy of three different ablation strategies in patients with persistent AF: PV antral isolation alone (PVAI) PV antral isolation plus ablation of drivers (PVAI+drivers) PV antral isolation plus isolation of posterior wall (PVAI+box) All three strategies will employ contemporary catheter ablation technology using more efficient open irrigated tip cooling and contact force sensing.

Start: June 2021

A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE)

The primary objective is to demonstrate safety and long-term effectiveness of the irreversible electroporation (IRE) system (Circular IRE Catheter and IRE Generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF).

Start: August 2020

Catheter Ablation vs. AADs and Risk Factor Modification.

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia with a prevalence of 2% in general population. Incidence and prevalence of AF has been slightly increasing due to increasing age, improved ability to treat cardiac diseases, and higher incidence of obesity and other risk factors associated with AF. AF is associated with higher morbidity and mortality mainly caused by heart failure and stroke. Catheter ablation (with pulmonary vein isolation as a cornerstone) presents the most effective treatment method of AF. Recent observational studies have shown that intensive risk factor and lifestyle modifications, such as weight loss, reduced alcohol intake, and increased physical activity, are also associated with improved rhythm outocome. Head-to-head comparison of this very different methods has not been done yet. The aim of the project is to compare the effect of catheter ablation with lifestyle modification (risk factor modification) in a prospective, randomized, multicenter study on the maintenance of sinus rhythm (monitored using implantable ECG reveal), and on the progression of the fibrosis of the left ventricle.

Start: May 2021

Cryo Global Registry

Cryo Global Registry a prospective, global, multi-center, observational Post-Market Registry

Start: May 2016

ReAHEAD: A Study to Find Out Whether Education Improves Adherence to Dabigatran in People With Atrial Fibrillation Who Are Younger Than 75 Years

Lifelong oral anticoagulant (OAC) therapy is the preferred treatment for the prevention of thromboembolic events in the majority of patients with Atrial Fibrillation (AF). Adherence to medication is essential for valid treatment for OAC therapy. The study aims to explore whether the advanced educational intervention would improve the adherence to dabigatran.

Start: August 2020

MultiPulse Therapy (MPT) for AF

Assess the clinical safety and feasibility of MultiPulse Therapy (MPT) electrical stimulation waveform sequence in terminating paroxysmal and persistent atrial fibrillation.

Start: March 2020

Study to Gather Information About the Safety of Oral Anticoagulation Drugs and How Well These Drugs Work in Real World for Patients With Non-valvular Atrial Fibrillation (Irregularly Heart Beats Which is Not Caused by a Heart Valve Problem)

Oral anticoagulant (OAC) treatment with either vitamin K antagonists (VKAs) or non-vitamin K antagonist oral anticoagulants (NOACs) is essential in patients with atrial fibrillation for the prevention of stroke or systemic embolism (SE) a condition that happens when a blood clot forms elsewhere in the body and travels through the blood stream to plug another vessel. While there are significant number of real-world publications on the use and outcomes of NOACs for stroke prevention, evidence from routine clinical practice on the use and outcomes of reduced doses of NOACs is scarce. By evaluating routine clinical practice data from national registers in Denmark, Finland, Norway and Sweden, researchers want to gather information about the safety and how well reduced doses of NOACs work in patients with irregularly heartbeats which are not caused by a heart valve problem (non-valvular atrial fibrillation, NVAF). As a primary aim of this study, treatment with low doses of NOACs (Xarelto [generic name rivaroxaban], Eliquis [generic name apixaban] or Pradaxa [generic name dabigatran]) will be compared with VKAs (warfarin) in Nordic patients with NVAF to assess the occurrence of stroke and systemic embolism [effectiveness]) and intracranial hemorrhage a type of bleeding that occurs inside the skull [safety]).

Start: March 2020

CHAMPION-AF Clinical Trial

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

Start: October 2020

Epigenetic Analysis of Regulation of the Inflammasome-activating NLRP3 Gene in Monocytes From Atrial Fibrillation Patients and Controls

The study will analyze blood from volunteers to determine whether there is an underlying epigenetic cause of the inflammation of the heart associated with atrial fibrillation (AF) and its progression with age. Confirming the regions of epigenetic elements associated with upregulation of the inflammatory genes will help the investigators in identifying target sites for developing future therapeutic interventions. The investigators propose to confirm the monocyte-cell type specific DNA methylation profile of NOD-, LRR- and pyrin domain-containing protein 3 (NLRP3) and determine the age-related and AF-related changes in DNA methylation and expression of NLRP3 in monocytes. This study will provide insights into the epigenetic regulation of NLRP3 in young and elderly patients, as well as in AF patients vs. controls which will help in devising methods of modulating NLRP3 expression and decreasing cardiac fibrosis progression.

Start: July 2021

Effect of Dronedarone on Atrial Fibrosis Progression and Atrial Fibrillation Recurrence

Patients who have undergone cardiac ablation will be randomized and blinded to one of two groups; one group will receive dronedarone while the other group will receive a placebo. The incidence of atrial fibrillation recurrence, as well as atrial fibrosis progression, will be analyzed between the two trial groups.

Start: May 2021

AMPLATZER™ LAA Occluder Post Approval Study (PAS)

The AMPLATZER LAA Occluder is a transcatheter, self-expanding nitinol device intended for use in preventing thrombus embolization from the LAA. The purpose of this study is to compile real world outcome data on the use of AMPLATZER LAA Occluder in subjects with non-valvular atrial fibrillation (NVAF)

Start: October 2016

Rotational Angiography in Cryoballoon Ablation

There is still unresolved question weather preprocedural imaging of left atrium and pulmonary veins is needed before the pulmonary vein isolation procedure for the treatment of atrial fibrillation. The investigators are conducting a randomized study to determine if 3D rotational angiography (as a mode of preprocedural imaging) performed before the cryoballoon ablation, facilitates the procedure and has positive impact on procedure characteristics and outcomes.

Start: September 2019

Early Aggressive Invasive Intervention for Atrial Fibrillation

The EARLY-AF study is centered on an evaluation of the impact of the early invasive management of Atrial Fibrillation. The primary goal of the study is to evaluate the clinical effectiveness of an early invasive approach. Specifically, the investigators are aiming to evaluate if PVI performed with the Arctic Front cryoballoon is superior to AAD as first-line therapy in preventing atrial arrhythmia recurrences (arrhythmia related symptoms, hospitalisations, and health care utilization).

Start: January 2017

LUX-Dx Insertable Cardiac Monitor Remote Programming and Performance Study

The LUX-Dx PERFORM Study will characterize, in a general patient population, the utilization of the remote programming feature of the Boston Scientific (BSC) Insertable Cardiac Monitor (ICM) device. The study will also collect data to characterize the performance of arrhythmia detection algorithms. Finally, data collected will be used to analyze and characterize the ICM system-related safety events.

Start: March 2021

Pulmonary Vein Isolation With Versus Without Continued Antiarrhythmic Drugs in Persistent Atrial Fibrillation

In the POWDER 1 study, paroxysmal atrial fibrillation (AF) patients undergoing conventional contact force (CF)-guided PVI were investigated. Patients were randomized between continuing previously ineffective antiarrhythmic drug therapy (ADT) or stopping ADT at the end of the blanking period. This trial, showed an added value of ADT after ablation (in support of 'hybrid rhythm control' as an alternative treatment strategy for AF in some patients). In the POWDER 2 trial, an analogue study in persistent AF patients will be performed. All patients will undergo ablation index (AI)- and IL distance (ILD)-guided PVI (just like in VISTAX trial) and continue previously ineffective ADT during the blanking period. 'PVI only' was chosen as the ablation strategy according to the STAR AF trial findings.

Start: February 2018

Amplatzer Amulet LAAO vs. NOAC

The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy. The clinical investigation is a prospective, randomized, multicenter active control worldwide trial. Subjects will be randomized in a 1:1 ratio between the Amulet LAA occlusion device ("Device Group") and a commercially available NOAC medication ("Control Group"). The choice of NOAC in the Control Group will be left to study physician discretion.

Start: July 2020

Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG

The primary objective of this study is to evaluate the effectiveness (prevention of thromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC) to background antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery. All patients with a qualifying POAF event, who decline randomization, will be offered the option of enrollment in a parallel registry that captures their baseline risk profile and their treatment strategy in terms of anticoagulants or antiplatelets received. These patients will also be asked to fill out a brief decliner survey.

Start: December 2019

Substrate Versus Trigger Ablation for Paroxysmal Atrial Fibrillation

This is a prospective randomized study to assess the safety and efficacy of FIRM (Focal Impulse and Rotor Modulation)-guided ablation for the treatment of symptomatic atrial fibrillation (AF). The study hypothesis is that the efficacy of AF elimination at 1 year will be higher by ablating patient-specific AF-sustaining rotors and focal sources by Focal Impulse and Rotor Modulation (FIRM) compared to conventional ablation alone (wide-area PV isolation).

Start: February 2016