Clinical trials: Atrial Fibrillation and Flutter
Paroxysmal Atrial Fibrillation
The FARAPULSE FARA-Freedom Trial
The Post-Market Clinical Follow-Up trial is a prospective, multi-center, open-label, single-arm clinical follow-up study designed to provide long-term safety feasibility, effectiveness and performance of the FARAPULSE Pulsed…
- Trial name
- FARA-Freedom (NCT05072964)
- Testing
- FARAPULSE Pulsed Field Ablation System
- Where
- 13 sites in Belgium, Czechia and 4 more
- Volunteers
- 180 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, Atrial Flutter
Comparison of Intracardiac Echocardiography and Transesophageal Echocardiography
The presence of intracardiac thrombi and their propensity for systemic embolism is a major concern in patients with atrial fibrillation (AF) and atrial flutter (AFL) undergoing cardioversion and ablation procedures.
- Trial name
- ICE-TEE (NCT02213666)
- Testing
- Intracardiac Imaging
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- Elad Anter
Symptomatic Atrial Fibrillation, Atrial Flutter
Safety and Efficacy of Vanoxerine for Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm
Evaluate the safety and efficacy of a single oral dose of vanoxerine compared to placebo, in a dose modification manner, on the conversion of symptomatic atrial fibrillation (a-fib) or flutter of recent onset to normal sinus…
- Trial name
- COR-ART (NCT01691313)
- Testing
- Vanoxerine
- Where
- 6 sites in Israel, Russia
- Volunteers
- 104 people
- Sponsor
- Laguna Pharmaceuticals, Inc.
Atrial Fibrillation, Atrial Flutter
Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk
The IMPACT Study will investigate the potential clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) technology and a predefined anticoagulation plan compared to conventional device evaluation and…
- Conditions
- Atrial Fibrillation, Atrial Flutter, Stroke, Embolism, Systemic Arterial
- Trial name
- IMPACT (NCT00559988)
- Testing
- Home Monitoring Guided OAC, Physician-Directed OAC
- Where
- 80 sites in United States, Australia and 4 more
- Volunteers
- 2,718 people
- Sponsor
- Biotronik, Inc.
Atrial Fibrillation, Atrial Flutter
Evaluate the Pharmacokinetics and Safety of MK-4448 in Participants With Nonvalvular Atrial Fibrillation or Atrial Flutter
The primary purpose of this study is to optimize drug exposure in the target population.
- Trial name
- NCT01229254
- Testing
- Amiodarone, Betrixaban 60 mg, Betrixaban 90 mg
- Volunteers
- 189 people
- Sponsor
- Portola Pharmaceuticals
Atrial Fibrillation, Atrial Flutter
Prophylaxis to Reduce Postoperative Atrial Fibrillation in Cardiac Surgery
Atrial Fibrillation (AF) is a common postoperative complication of cardiac surgery, occuring in approximately 25-30% of coronary artery bypass graft (CABG) patients and 35-40% of heart valve repair/replacement patients.
- Trial name
- NCT00953212
- Testing
- beta blockers, amiodarone, ascorbic acid
- Where
- United States
- Volunteers
- 304 people
- Sponsor
- MaineHealth
Atrial Fibrillation, Atrial Flutter
A Trial With Dronedarone to Prevent Hospitalization or Death in Patients With Atrial Fibrillation
To assess the efficacy of dronedarone in preventing cardiovascular hospitalization or death from any cause in a population of high-risk patients with atrial fibrillation/atrial flutter (AF/AFL).
- Trial name
- ATHENA (NCT00174785)
- Testing
- dronedarone (SR33589)
- Where
- 37 sites in United States, Argentina and 35 more
- Volunteers
- 4,628 people
- Sponsor
- Sanofi
Atrial Fibrillation Fluttering
Ankle - Brachial Index Measurement in Atrial Fibrillation
Consecutive patients with atrial fibrillation will be admitted to the hospital for electrical cardioversion. Ankle brachial index will be measured three times with oscillometric method and three times with doppler method.
- Trial name
- AFABI (NCT02986282)
- Testing
- ABI measurement using both doppler and oscillometric method
- Volunteers
- 115 people
- Sponsor
- Medical University of Warsaw
Atrial Fibrillation, Atrial Flutter
Evaluation of the Amigo Robotic System for Ablation of the Cavo-Tricuspid Isthmus
The purpose of this study is to compare standard manual and robotically controlled catheter ablation of the cavo-tricuspid isthmus (CTI) as a treatment for atrial flutter.
- Trial name
- Amigo-AFL (NCT02467179)
- Testing
- Amigo™ Robotic Catheter Manipulation, Manual Catheter Manipulation
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of California, San Diego
Cardiac Arrhythmia
EnSite Precision Observational Study
This document is a clinical investigation plan (CIP) for the EnSite Precision Observational Study. This clinical study is intended to quantify and characterize the usage of the EnSite Precision™ Cardiac Mapping System (Software…
- Trial name
- NCT03260244
- Testing
- cardiac mapping and radiofrequency ablation procedure
- Where
- 7 sites in United States
- Volunteers
- 1,065 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Atrial Flutter
An Initial Assessment of the Sphere-9™ Catheter and Affera Mapping and Ablation System
A prospective, single-arm, multi-center, safety and performance assessment of the Sphere-9™ Catheter and the Affera Mapping and Ablation System to treat Atrial Arrhythmias
- Trial name
- NCT04210622
- Testing
- Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System
- Where
- Lithuania
- Volunteers
- 16 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Arrhythmia, Atrial Fibrillation
Concentrations of Amiodarone in Fat Tissue During Chronic Treatment
The objective of this study is to determine if concentrations of amiodarone in fat tissue increases constantly over time during chronic treatment with this drug, and if blood concentrations reflect accurately the concentrations…
- Conditions
- Arrhythmia, Atrial Fibrillation, Atrial Flutter
- Trial name
- ATACA (NCT00313443)
- Testing
- Fat tissue needle aspiration
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Hopital Lariboisière
Death, Sudden, Cardiac, Ventricular Fibrillation
DISCOVERY: Diagnostic Data and Genetic Polymorphisms in ICD Patients.
To prospectively evaluate if the analysis of genetic polymorphisms can be used to identify patients at risk of ventricular tachycardia.
- Conditions
- Death, Sudden, Cardiac, Ventricular Fibrillation, Tachycardia, Atrial Fibrillation
- Trial name
- DISCOVERY (NCT00478933)
- Testing
- Defibrillator, Dual Chamber ; Implantable, Blood sampling
- Volunteers
- 1,223 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation, Atrial Flutter
Wire Instrumentation Using Radiofrequency Energy to Impact Transseptal Efficiency
This is a randomized controlled trial examining whether Baylis's Versacross RF wire versus the conventional Baylis RF needle is better at puncturing through a thin wall in the heart (called "transseptal puncture") as measured by…
- Trial name
- WIRE-IT (NCT04645342)
- Testing
- Baylis Versacross RF wire, Baylis RF needle
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- University of California, San Francisco
Atrial Fibrillation, Atrial Flutter
Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism
The purpose of this study is to evaluate major adverse bleeding risks, and thromboembolic event rates post radiofrequency (RF) ablation.
- Trial name
- NCT01976507
- Testing
- dabigatran etexilate mesylate
- Where
- United States
- Volunteers
- 101 people
- Sponsor
- Vanderbilt University Medical Center