Clinical trials: Atrial Fibrillation, Paroxysmal
Atrial Fibrillation
SMART-SF Radiofrequency Ablation Safety Study
This is a prospective safety assessment of the study device during radiofrequency (RF) ablation treatment of patients with drug refractory symptomatic atrial fibrillation (SMART-SF).
- Trial name
- NCT02359890
- Testing
- THERMOCOOL® SMARTTOUCH® (RF ablation treatment)
- Volunteers
- 165 people
- Sponsor
- Biosense Webster, Inc.
Heart Diseases, Arrhythmia
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
The purpose of this study is to demonstrate the safety and effectiveness of the THERMOCOOL® SMARTTOUCH™ Catheters with Contact Force Sensing Capability in the treatment of drug refractory symptomatic paroxysmal Atrial…
- Conditions
- Heart Diseases, Arrhythmia, Atrial Fibrillation
- Trial name
- NCT01385202
- Testing
- THERMOCOOL® SMARTTOUCH™ Catheter
- Volunteers
- 172 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation, Paroxysmal AF
CARTO® 3 System and Real Time Intracardiac Ultrasound
This is a prospective, multicenter, non-randomized observational study of subjects 18 years and older undergoing RF ablation with drug refractory recurrent symptomatic paroxysmal Atrial Fibrillation (AF).
- Trial name
- IUAF (NCT01716663)
- Testing
- Catheter Ablation
- Where
- 26 sites in United States
- Volunteers
- 234 people, healthy volunteers welcome
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation
IMPULSE: A Safety and Feasibility Study of the IOWA Approach Endocardial Ablation System to Treat Atrial Fibrillation
IMPULSE is a prospective, single-arm, multi-center, safety and feasibility study evaluating the IOWA Approach Endocardial Ablation System (FARAPULSE, Inc.) for the treatment of paroxysmal atrial fibrillation.
- Trial name
- NCT03700385
- Testing
- IOWA Approach Endocardial Ablation System
- Where
- 2 sites in Czechia, France
- Volunteers
- 40 people
- Sponsor
- Boston Scientific Corporation
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
Paroxysmal Atrial Fibrillation
Study of HD Mesh Ablation System for Treatment of Paroxysmal Atrial Fibrillation
This is a randomized controlled study of the Bard High Density Mesh Ablation System for treatment of paroxysmal atrial fibrillation.
- Trial name
- MAGELLAN (NCT00741611)
- Testing
- HD Mesh Ablation System, Anti-arrhythmic drugs
- Where
- 13 sites in United States
- Volunteers
- 44 people
- Sponsor
- C. R. Bard
Paroxysmal Atrial Fibrillation
TactiFlex Paroxysmal Atrial Fibrillation IDE Trial
Prospective non-randomized parallel-assignment multi-center clinical investigation. The study design includes two subject cohorts: 1) Paroxysmal Atrial Fibrillation Main Study, and 2) Paroxysmal Atrial Fibrillation High Standard…
- Trial name
- NCT04356040
- Testing
- TactiFlex SE, TactiFlex SE - High Standard Power
- Where
- 45 sites in United States, Australia and 8 more
- Volunteers
- 355 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Atrial Fibrillation
Ectopy Triggering Ganglionated Plexus Ablation to Prevent Atrial Fibrillation
Atrial fibrillation (AF) is a common heart rhythm disorder which can significantly affect a patient's quality of life and cause strokes.
- Trial name
- GANGLIA-AF (NCT02487654)
- Testing
- Pulmonary vein isolation, Ganglionated plexus ablation
- Where
- 3 sites in United Kingdom
- Volunteers
- 116 people
- Sponsor
- Imperial College London
Refractory Paroxysmal Atrial Fibrillation
A Study of Multi-electrode Circular Irreversible Electroporation (IRE) Catheter and Multi-Channel IRE Generator in Paroxysmal Atrial Fibrillation (AF)
The purpose of this study is to evaluate the long term off-Antiarrhythmic Drug (AAD) effectiveness of Biosense Webster, Inc. Irreversible Electroporation (BWI IRE) system in treatment of participants with symptomatic drug…
- Trial name
- AFIRE (NCT05552963)
- Testing
- Multi-Channel Irreversible Electroporation (IRE) Generator, Multi-Channel Circular IRE Catheter
- Where
- 6 sites in China
- Volunteers
- 142 people
- Sponsor
- Biosense Webster, Inc.
Arrhythmia
Qubic Stim Cardiac Stimulator in China
106 subjects selected from 3 study sites in China are with indications for intracardiac electrophysiological examination. The trial is to prove the clinical effectiveness and safety of Qubic Stim Cardiac Stimulator in Chinese…
- Trial name
- NCT04390841
- Testing
- Cardiac Stimulator
- Where
- 3 sites in China
- Volunteers
- 106 people
- Sponsor
- Biotronik (Beijing) Medical Device Ltd.
Atrial Fibrillation Paroxysmal
Efficacy of Personalized Exercise Program and Trimetazidine in Rehabilitation of Patients After RFA of AF
Atrial fibrillation (AF) is one of the most common forms of heart rhythm disorder in patients with cardiovascular diseases. The choice of treatment for AF is a complex problem, depending on the form (paroxysmal, persistent…
- Trial name
- NCT04511520
- Testing
- Physical training program, Trimetazidine
- Volunteers
- 72 people
- Sponsor
- National Research Center for Preventive Medicine
Atrial Fibrillation
Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System
To demonstrate the safety and 12-month effectiveness of the VARIPULSE™ Catheter when used in conjunction with the TRUPULSE™ Generator for pulmonary vein isolation (PVI) in the treatment of subjects with symptomatic paroxysmal…
- Trial name
- AdmIRE (NCT05293639)
- Testing
- Pulse Field Ablation
- Where
- 30 sites in United States
- Volunteers
- 362 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation
Electrical Coupling Information From The Rhythmia HDx System And DirectSense Technology In Subjects With Paroxysmal Atrial Fibrillation
The objective of the study is to collect data on the use of the Rhythmia HDx mapping system running commercially available Software Version 2.0 or any future commercially available Software Version with DirectSense technology and…
- Trial name
- LOCALIZE (NCT03232645)
- Testing
- Ablation procedure
- Where
- 6 sites in France, Germany and 2 more
- Volunteers
- 62 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
Selective Complex Fractionated Atrial Electrograms (CFAE) Targeting for Atrial Fibrillation
This study will be a multicenter, open, prospective, randomized trial. Patients with either paroxysmal or persistent atrial fibrillation will be considered for the study.
- Trial name
- SELECT-AF (NCT00926783)
- Testing
- CFAE ablation
- Where
- 7 sites in United States, Australia and 1 more
- Volunteers
- 86 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation, Paroxysmal Arrhythmia
NAVISTAR® THERMOCOOL® SF Catheter: Observational Study
This is a prospective, interventional, observational, unblinded, single-arm, multicenter registry of younger and older subjects with drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation.
- Trial name
- SFAF (NCT01585961)
- Testing
- Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter)
- Where
- 45 sites in United States
- Volunteers
- 511 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation
Clinical Study of the CardioFocus Endoscopic Ablation System for the Treatment of Symptomatic AF
The purpose of this study is to determine the safety and effectiveness of the endoscopic ablation system - adaptive contact (EAS-AC) in treated paroxysmal atrial fibrillation (PAF) with pulmonary vein isolation (PVI).
- Trial name
- NCT00958165
- Testing
- CardioFocus EAS-AC
- Where
- 3 sites in Germany
- Volunteers
- 81 people
- Sponsor
- CardioFocus
Paroxysmal Atrial Fibrillation
A Blinded Study to Evaluate Effect on Atrial Fibrillation Burden in Patients With Paroxysmal Atrial Fibrillation
The purpose of this study is to evaluate the effect of BMS-919373 on atrial fibrillation (AF) through its effect on AF burden (AFB), or the percent of time in AF, in subjects with paroxysmal AF (pAF) when administered orally at a…
- Trial name
- NCT02156076
- Testing
- BMS-919373
- Where
- 35 sites in United States, Canada
- Volunteers
- 158 people
- Sponsor
- Bristol-Myers Squibb
Atrial Fibrillation
Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
The primary objective of this clinical investigation is to demonstrate safety and effectiveness of the Multi-Electrode RF Balloon catheter for the treatment of drug refractory symptomatic paroxysmal atrial fibrillation.
- Trial name
- STELLAR (NCT03683030)
- Testing
- Multi-Electrode RF Balloon Catheter
- Where
- 41 sites in United States, China and 1 more
- Volunteers
- 397 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
Adenosine to Assess Complete Conduction Block During Catheter Ablation of Paroxysmal Atrial Fibrillation
The purpose of this study is to determine if additional ablation during the first procedure as the result of the ability to medically induce quiet atrial arrhythmias will improve clinical outcome in patients with atrial…
- Trial name
- NCT03032965
- Testing
- Adenosine, Isoproterenol
- Where
- United States
- Volunteers
- 131 people
- Sponsor
- University of Michigan
Paroxysmal Atrial Fibrillation
FIRM Ablation Versus Pulmonary Vein Isolation for the Treatment of Paroxysmal Atrial Fibrillation (PAF)
The study is designed as a prospective, multicenter, single-blind, randomized study to assess the safety and effectiveness of FIRM-guided radiofrequency (RF) ablation procedures for the treatment of symptomatic paroxysmal atrial…
- Trial name
- FIRMAP-AF (NCT02703454)
- Testing
- FIRM-guided RF ablation, Conventional RF ablation
- Where
- Germany
- Volunteers
- 51 people
- Sponsor
- Abbott Medical Devices