Clinical trials: Atrial Fibrillation, Paroxysmal
Atrial Fibrillation
Predictive Factors for Successful Outcome After Pulmonary Veins Ablation to Treat Paroxysmal Atrial Fibrillation
Atrial fibrillation is the most common serious abnormal heart rhythm affecting about 2% to 3% of the population, being associated with a 1.5- to 1.9-fold higher risk of death.
- Trial name
- NCT02614521
- Testing
- pulmonary veins ablation's successful outcome
- Where
- Greece
- Sponsor
- Elpen Pharmaceutical Co. Inc.
Atrial Fibrillation
Clinical Study for Workflow and Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System for Treating Symptomatic Paroxysmal AF (QDOT-Micro)
The QDOT-Micro study is a prospective, multi-center, non-randomized, interventional clinical study.
- Trial name
- NCT02944968
- Testing
- THERMOCOOL SMARTTOUCH® SF-5D catheter
- Volunteers
- 51 people
- Sponsor
- Biosense Webster, Inc.
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
The purpose of this study is to assess the safety and feasibility of the investigational catheter for mapping the atrial and ventricular regions of the heart.
- Conditions
- Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Ventricular Tachycardia
- Trial name
- FEATHER (NCT07116525)
- Testing
- Paddle-Shaped, High-Density, Multi-Electrode Mapping Catheter
- Where
- 5 sites in Belgium, France and 1 more
- Volunteers
- 90 people
- Sponsor
- Biosense Webster, Inc.
Symptomatic Paroxysmal Atrial Fibrillation (PAF)
FIRE AND ICE: Comparative Study of Two Ablation Procedures in Patients With Atrial Fibrillation
Comparing efficacy and safety of isolation of the pulmonary veins (PV) using a Cryoballoon catheter versus a radiofrequency ablation with a ThermoCool catheter in patients with paroxysmal atrial fibrillation.
- Trial name
- NCT01490814
- Testing
- Electrical isolation of the pulmonary veins, Electrical isolation of pulmonary veins
- Where
- 19 sites in Czechia, France and 6 more
- Volunteers
- 769 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation
ABLATE Post Approval Study - Synergy Ablation Lesions for Non-Paroxysmal Atrial Fibrillation
The primary objective of this post-approval study is to evaluate the clinical outcomes in a cohort of patients with non-paroxysmal forms of atrial fibrillation (persistent or long-standing persistent) treated during commercial…
- Trial name
- ABLATE-PAS (NCT01694563)
- Testing
- Synergy Ablation System
- Where
- 49 sites in United States
- Volunteers
- 365 people
- Sponsor
- AtriCure, Inc.
Paroxysmal Atrial Fibrillation
POLARx Post Approval Study (POLARx PAS)
To collect clinical data on safety, effectiveness and procedural success of Boston Scientific's Cardiac Cryoablation System (includes all BSC commercially available POLARx/POLARx Fit catheters) when used to perform pulmonary vein…
- Trial name
- NCT06170606
- Testing
- Boston Scientific Cardiac Cryoablation System
- Where
- 11 sites in United States
- Volunteers
- 200 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
A Study For Treatment of Paroxysmal Atrial Fibrillation (PAF) With the OMNYPULSE Catheter and the TRUPULSE Generator
The purpose of this study is to demonstrate safety and effectiveness of the ablation system (OMNYPULSE Bi-directional catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of…
- Trial name
- Omny-IRE (NCT05971693)
- Testing
- OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator
- Where
- 13 sites in Belgium, Canada and 6 more
- Volunteers
- 188 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation
Flecainide Acetate Inhalation Solution for Cardioversion of Recent-Onset, Symptomatic Atrial Fibrillation
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical study designed to evaluate the efficacy and safety of FlecIH-103 (flecainide acetate inhalation solution) compared with placebo in patients…
- Trial name
- RESTORE-1 (NCT05039359)
- Testing
- FlecIH-103
- Where
- 40 sites in United States, Czechia and 4 more
- Volunteers
- 54 people
- Sponsor
- InCarda Therapeutics, Inc.
Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation
Medtronic Terminate AF Study
The purpose of this study is to demonstrate the safety and effectiveness of the Cardioblate iRF and CryoFlex hand held devices for the treatment of non-paroxysmal atrial fibrillation (AF).
- Trial name
- NCT03546374
- Testing
- Surgical Ablation, Cardioblate and Cryoflex hand held devices
- Where
- 15 sites in United States
- Volunteers
- 160 people
- Sponsor
- Medtronic Cardiac Surgery
Atrial Fibrillation
A Study For Treatment Of Paroxysmal Atrial Fibrillation (PAF) With The THERMOCOOL SMARTTOUCH SF Catheter and TRUPULSE Generator
The purpose of this study is to demonstrate safety and effectiveness of the ablation system (THERMOCOOL SMARTTOUCH SF [STSF] catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in…
- Trial name
- SmartfIRE (NCT05752487)
- Testing
- Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation
- Where
- 9 sites in Austria, Belgium and 2 more
- Volunteers
- 149 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation
Clinical Investigation of the VytronUS Ablation System for Treatment of Symptomatic Drug-refractory Paroxysmal Atrial Fibrillation
VITAL is a prospective, single arm, multicenter, interventional study to evaluate the safety and effectiveness of the VytronUS Ablation System (VAS) for the treatment of symptomatic paroxysmal atrial fibrillation (PAF) using low…
- Trial name
- VITAL (NCT03513029)
- Testing
- VytronUS Ablation System
- Where
- Czechia
- Volunteers
- 100 people
- Sponsor
- VytronUS, Inc.
Paroxysmal Atrial Fibrillation
TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation
The TOCCASTAR Study will assess the safety and effectiveness of a contact force sensing catheter used for ablation in patients with paroxysmal atrial fibrillation.
- Trial name
- TOCCASTAR (NCT01278953)
- Testing
- Catheter ablation to treat paroxysmal atrial fibrillation
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
Pivotal Clinical Study of Endoscopic Ablation for Atrial Fibrillation (AF) in Patients That Have Failed Drugs
The purpose of the study is to compare two types of treatment for atrial fibrillation (AF) that are designed to treat the symptoms of atrial fibrillation.
- Trial name
- ENABLE (NCT00477230)
- Testing
- Endoscopic Ablation System, Standard Anti-arrhythmic Drug (AAD) Therapy
- Where
- 18 sites in United States
- Volunteers
- 64 people
- Sponsor
- CardioFocus
Atrial Fibrillation
Safety and Performance of the Affera SpherePVI™ Multi-Ablation System to Treat Paroxysmal Atrial Fibrillation
A prospective, single-arm, multi-center study to evaluate the safety, performance, and effectiveness of the Affera SpherePVI™ Multi-Ablation System for treating paroxysmal atrial fibrillation.
- Trial name
- SpherePVI (NCT05115214)
- Testing
- SpherePVI™ Catheter
- Where
- 2 sites in Czechia
- Volunteers
- 150 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Paroxysmal Atrial Fibrillation
Catheter Ablation Using a Novel Navigation and Imaging System
The objective of the ENVIsIoN study is to collect data on the use of the VERAFEYE navigation and imaging system in patients indicated to undergo a catheter ablation procedure for the treatment of Paroxysmal Atrial Fibrillation…
- Trial name
- ENVIsIoN (NCT06895187)
- Testing
- VERAFEYE System
- Volunteers
- 100 people
- Sponsor
- LUMA Vision Ltd.
Paroxysmal Atrial Fibrillation
A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation
This study (STOP AF) is a prospective, randomized, controlled, multicenter, pivotal clinical investigation conducted at 26 investigational sites in the United States and Canada.
- Trial name
- Stop-AF (NCT00523978)
- Testing
- Arctic Front® Cryoablation Catheter, Flecainide or Sotalol or Propafenone
- Where
- 26 sites in United States, Canada
- Volunteers
- 245 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation CONTINUED ACCESS
This is a prospective, multicenter, non-randomized continued access clinical evaluation utilizing the THERMOCOOL® SMARTTOUCH™ catheter.
- Trial name
- NCT01639495
- Testing
- THERMOCOOL® SMARTTOUCH™ Catheter
- Where
- 20 sites in United States
- Volunteers
- 148 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation
STOP AF First Post-Approval Study
The STOP AF First PAS is a prospective, global, multi-center, observational trial.
- Trial name
- NCT05227053
- Testing
- Arctic Front™ Cardiac Cryoablation Catheter
- Where
- 11 sites in United States
- Volunteers
- 142 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Arrhythmia, Atrial Fibrillation
VOLT-AF IDE Clinical Study
This clinical investigation is intended to demonstrate safety and effectiveness of the Volt™ Pulsed Field Ablation (PFA) Catheter Sensor Enabled™, the Volt™ PFA Generator, Agilis™ NxT Steerable Introducer Dual-Reach™, and EnSite™…
- Conditions
- Atrial Arrhythmia, Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
- Trial name
- NCT06223789
- Testing
- Pulsed Field Ablation
- Where
- 40 sites in United States, Australia and 9 more
- Volunteers
- 392 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Evaluation of Novel Waveforms Delivered Using the FARAPULSE™ PFA System
This is a multicenter, prospective, single-arm, feasibility study to evaluate the safety and effectiveness of the waveforms being delivered using the FARAPULSE PFA System in patients with Paroxysmal Atrial Fibrillation (PAF) and…
- Trial name
- IMPULSE-EVO (NCT07444320)
- Testing
- FARAPULSE™ Pulsed Field Ablation (PFA) System
- Where
- 4 sites in Croatia, Czechia and 2 more
- Volunteers
- 200 people
- Sponsor
- Boston Scientific Corporation