Clinical trials: Ablation of Atrial Fibrillation
Atrial Fibrillation
A Study of VARIPULSE Pulsed Field Ablation (PFA) Catheter and FARAWAVE PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation
The purpose of this study is to assess how safe VARIPULSE pulsed field ablation (PFA) catheter is and how well it works compared to food and drug administration (FDA) approved FARAWAVE PFA catheter in participants with…
- Trial name
- PERSIGMA RCT (NCT07523750)
- Testing
- VARIPULSE Catheter, FARAWAVE Catheter
- Where
- 10 sites in United States
- Volunteers
- 566 people
- 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
Atrial Fibrillation
nContactSurgical Numeris-AF Tethered Coagulation System for Treatment of Persistent & LSP AF
This is a multi center, non-randomized, prospective, open label, clinical trial evaluating the safety and efficacy of the nContact Surgical Numeris-AF Tethered Coagulation System when used to treat patients with persistent and…
- Trial name
- NCT00950092
- Testing
- Numeris-AF Tethered Coagulation System with VisiTrax
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- nContact Surgical Inc.
Atrial Fibrillation (Paroxysmal)
Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant PFA Balloon for the Treatment of AF
This is a prospective, single-arm First-in-Human study to demonstrate the safety and effectiveness of the CardioFocus OptiShot Pulsed Field Ablation System for catheter ablation of atrial fibrillation (AF).
- Trial name
- VISION AF (NCT06828939)
- Testing
- pulsed field ablation
- Where
- Czechia
- Volunteers
- 100 people
- Sponsor
- CardioFocus
Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation
Dual Epicardial Endocardial Persistent Atrial Fibrillation (AF) Study
The purpose of this clinical investigation is to evaluate how safe a less invasive cardiac surgery is using the AtriCure Bipolar System combined with a catheter ablation procedure in treating AF, and how effective this combined…
- Trial name
- DEEP (NCT01246466)
- Testing
- Hybrid: AtriCure Bipolar System & EP ablation procedure
- Where
- 5 sites in United States
- Volunteers
- 24 people
- Sponsor
- AtriCure, Inc.
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.
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
Dual Epicardial Endocardial Persistent Atrial Fibrillation(AF) Study (Staged DEEP)
The purpose of this study is to assess the safety and technical feasibility of treating subjects with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation in a minimally invasive thoracoscopic ablation…
- Trial name
- Staged DEEP (NCT01661205)
- Testing
- Ablation procedure staged catheter ablation
- Where
- 6 sites in United States, Belgium and 1 more
- Volunteers
- 30 people
- Sponsor
- AtriCure, Inc.
Paroxysmal Atrial Fibrillation
Pilot Study Evaluating the Toray Satake Balloon Thermal Ablation System for Treatment of Paroxysmal Atrial Fibrillation
The purpose of this study is to collect preliminary safety and effectiveness data evaluating the Toray Satake Balloon Thermal Ablation System (TSB)to treat subjects with symptomatic paroxysmal atrial fibrillation that is…
- Trial name
- NCT01997736
- Testing
- Ablation
- Where
- 4 sites in United States
- Volunteers
- 41 people
- Sponsor
- Toray Industries (America), Inc.
Paroxysmal Atrial Fibrillation
Prospective Evaluation of Open Irrigated Ablation Catheters With High Resolution Mapping to Treat Paroxysmal Atrial Fibrillation
To obtain data for the Rhythmia™ Mapping System in conjunction with Boston Scientific Open-Irrigated (OI) Catheters for ablation of Paroxysmal Atrial Fibrillation (PAF) according to current international and local guidelines.
- Trial name
- INTERRUPT AF (NCT03729830)
- Testing
- Boston Scientific Open Irrigated Ablation Catheters
- Where
- 26 sites in United States, Germany and 4 more
- Volunteers
- 415 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
Efficacy, Safety and Efficiency Study of CARTO® 3 System Guided THERMOCOOL® Catheter Ablation Versus Fluoroscopy Guided Ablation With the Pulmonary Vein Ablation Catheter® (PVAC®)
The purpose of this study is to compare the efficacy, safety and efficiency of CARTO® 3 system guided THERMOCOOL® catheter ablation and fluoroscopy guided Pulmonary Vein Ablation Catheter® (PVAC®) guided ablation for the…
- Trial name
- CLARITY-AF (NCT01116557)
- Testing
- Radiofrequency Ablation procedure
- Volunteers
- 79 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
Safety and Effectiveness of STSF Catheter Evaluated for Treating Symptomatic Persistent Atrial Fibrillation (PsAF)
This is a prospective, multicenter, non-randomized clinical evaluation utilizing the THERMOCOOL SMARTTOUCH® SF catheter compared to a predetermined performance goal.
- Trial name
- PRECEPT (NCT02817776)
- Testing
- THERMOCOOL SMARTTOUCH® SF catheter
- Volunteers
- 381 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
Edoxaban Treatment Versus Vitamin K Antagonist (VKA) in Patients With Atrial Fibrillation (AF) Undergoing Catheter Ablation
There are insufficient data on the safety and efficacy of edoxaban therapy in subjects with AF following catheter ablation. This phase 3b study is designed to evaluate the safety and to explore the efficacy of an edoxaban-based…
- Trial name
- ELIMINATE-AF (NCT02942576)
- Testing
- Edoxaban, VKA-Based Regimen
- Where
- 75 sites in Belgium, Canada and 9 more
- Volunteers
- 632 people
- Sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Atrial Fibrillation
PRECISION GOLD Post Market Study in Europe of Pulmonary Vein Ablation Catheter (PVAC GOLD)
PRECISION GOLD is a prospective, multi-center, single arm, unblinded interventional post market clinical study conducted in Europe.
- Trial name
- NCT01767558
- Testing
- Ablation / MRI
- Where
- 11 sites in Belgium, France and 4 more
- Volunteers
- 56 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Rapid Arrhythmia, Atrial Fibrillation (AF)
Safety and Efficacy Study of the First Domestically Produced FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter Therapy for Rapid Arrhythmia With Tissue Temperature Measurement Function
This project aims to evaluate the safety, efficacy, and cost-effectiveness of using FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter to treat rapid arrhythmias.
- Conditions
- Rapid Arrhythmia, Atrial Fibrillation (AF), Paroxysmal Supraventricular Tachycardia (PSVT)
- Trial name
- NCT07032948
- Testing
- FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter、EasyStars™ High Density Mapping Catheter、Columbus™ 3D EP Navigation System
- Volunteers
- 300 people
- Sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.
Paroxysmal AF
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
The study is a prospective, single-arm, pre-market clinical study and will enroll up to 300 subjects at up to 26 sites in the United States (US) for analysis of primary objectives.
- Trial name
- Horizon 360 (NCT07308847)
- Testing
- Sphere-360 Pulsed Field Ablation Catheter with the Affera Mapping and Ablation System
- Where
- 24 sites in United States
- Volunteers
- 300 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Persistent Atrial Fibrillation
Evaluation of the Phased Radio Frequency Ablation System
VICTORY AF is an IDE, prospective global, multi-center, single arm, controlled, unblinded, investigational clinical study. The purpose of this clinical study is to evaluate the risk of procedure and/or device related strokes in…
- Trial name
- VICTORY-AF (NCT01693120)
- Testing
- Medtronic Phased RF Ablation System
- Where
- 40 sites in United States, Canada and 3 more
- Volunteers
- 199 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation
Use of Volta Medical AI-software During Atrial Fibrillation Ablation to Identify Patients Who May Need More Than Pulmonary Vein Isolation.
DISPLAY-AF is a prospective, multicenter, single-arm post-market clinical follow-up investigation designed to evaluate whether spatiotemporal dispersion areas identified by the Volta AF-Xplorer II artificial intelligence (AI)…
- Trial name
- DISPLAY-AF (NCT07807423)
- Testing
- Complete biatrial mapping
- Where
- 5 sites in France
- Volunteers
- 125 people
- Sponsor
- Volta Medical
Atrial Fibrillation
Post-Market Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (CF-EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation
The purpose of this study is to confirm the safety and effectiveness of the CardioFocus Endoscopic Ablation System with Adaptive Contact in the treatment of atrial fibrillation.
- Trial name
- NCT01196923
- Testing
- Endoscopically Guided Ablation
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- CardioFocus
Atrial Fibrillation
AtriCure Minimally Invasive Surgical Ablation for Atrial Fibrillation/RESTORE IIB
Feasibility study arm to evaluate the safety of adding the left atrial linear connecting lesions of the Cox-Maze lesion set to the current RESTORE SR II IDE study procedure of performing pulmonary vein isolation, selected left…
- Trial name
- RESTORE SR IIB (NCT00571779)
- Testing
- AtriCure Bipolar System
- Sponsor
- AtriCure, Inc.