Clinical trials: Ablation of Atrial Fibrillation
Atrial Fibrillation
Repeatable Evaluation of Functional Intra-procedural Signals for Effect in Pulsed Field Ablation REFINE-PFA
The study is a prospective, exploratory observational study with the ECGenius® System and the PFAnalyzer software module in PFA cases using the FaraPulse PFA system.
- Trial name
- REFINE-PFA (NCT07275151)
- Testing
- Pulmonary vein isolation ablation
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- CathVision ApS
Atrial Fibrillation (AF), Atrial Arrhythmia
A Study of the TactiFlex SE Catheter and Volt PFA Generator in Subjects With PAF:
The objective of this clinical study is to demonstrate that ablation with the TactiFlex SE Ablation catheter, in conjunction with a compatible pulsed field ablation (PFA) and/or radio frequency (RF) generator, is safe and…
- Conditions
- Atrial Fibrillation (AF), Atrial Arrhythmia, Paroxysmal AF, Drug Refractory Paroxysmal Atrial Fibrillation
- Trial name
- FlexPulse IDE (NCT06676072)
- Testing
- PFA Ablation catheter
- Where
- 32 sites in United States, Austria and 2 more
- Volunteers
- 188 people
- Sponsor
- Abbott Medical Devices
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
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
Safety and Efficacy Study of The Combined Ablation Procedure To Treat Longstanding Persistent Atrial Fibrillation
This is a multi-center, prospective open label, feasibility study evaluating the safety and efficacy of the combined ablation procedure for the treatment of longstanding persistent atrial fibrillation.
- Trial name
- CAPstopsLSPAF (NCT01103661)
- Testing
- Numeris®-AF Guided Coagulation System with VisiTrax®
- Where
- 4 sites in United States
- Volunteers
- 7 people
- Sponsor
- nContact Surgical Inc.
Paroxysmal Atrial Fibrillation
NAVISTAR® THERMOCOOL® Catheter Post Approval Registry
The purpose of this registry is to provide additional corroborative short-term safety and long-term safety data for the NAVISTAR THERMOCOOL and NAVISTAR EZ STEER THERMOCOOL catheters in the treatment of symptomatic Paroxysmal…
- Trial name
- AF Registry (NCT00964392)
- Testing
- Atrial fibrillation ablation
- Volunteers
- 437 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation (AF)
Comparison of Different Pulsed Field Ablation Catheters in Atrial Fibrillation
Pulsed field energy ablation, a non-thermal ablation modality, can potentially reduce post-ablation tissue edema. Previous studies have confirmed the feasibility and safety of combined pulsed field ablation (PFA) and left atrial…
- Trial name
- COMBINATION 2P (NCT07036965)
- Testing
- CardiPulse, FaraPulse
- Where
- China
- Volunteers
- 292 people
- Sponsor
- Hangzhou Dinova EP Technology Co., Ltd
Atrial Fibrillation (AF), Persistant Atrial Fibrillation
A Global Study Comparing Pulsed Field Ablation With Electrographic Flow Mapping Versus Posterior Wall Ablation for Persistent Atrial Fibrillation
The purpose of this study is to establish the safety of the pulsed field ablation (PFA) therapy of Pulmonary Veins and Electrographic Flow (EGF) identified extra-PV sources of atrial fibrillation (PVI + EGF ablation of sources)…
- Trial name
- OPTIMIZE (NCT07187115)
- Testing
- FARAPOINT Pulsed Field Ablation System, OptiMap System (non-ablative), FARAPULSE Pulsed Field Ablation (PFA) System and Opal HDx Mapping System
- Where
- 15 sites in United States, Belgium and 2 more
- Volunteers
- 699 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
High Intensity Focused Ultrasound (HIFU) Ablation System Study
The purpose of this study is to determine if the HIFU Pulmonary Vein Ablation System is effective in the treatment of paroxysmal Atrial Fibrillation compared to the control of best medical therapy with FDA approved antiarrhythmic…
- Trial name
- NCT00392106
- Testing
- propafenone, flecainide, dofetilide
- Where
- 21 sites in United States, Czechia
- Volunteers
- 240 people
- Sponsor
- ProRhythm, Inc.
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
Atrial Fibrillation Paroxysmal, Cardiac Ablation
CellFX® Nanosecond Pulsed Field Ablation (PFA) 360 Catheter Ablation System for Treatment of Atrial Fibrillation
The objective of this study is to demonstrate initial safety and effectiveness of the CellFX nano-second Pulsed Field Ablation (nsPFA or nano-PFA) 360 Catheter Endocardial Ablation System in treating subjects with atrial…
- Conditions
- Atrial Fibrillation Paroxysmal, Cardiac Ablation, Cardiac Arrhythmia
- Trial name
- NCT06696170
- Testing
- CellFX nano-pFA 360 Endocardial Ablation Catheter System
- Where
- 3 sites in Belgium, Czechia and 1 more
- Volunteers
- 60 people
- Sponsor
- Pulse Biosciences, Inc.
Paroxysmal Atrial Fibrillation, Atrial Fibrillation
DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation
The purpose of the DIAMOND-AF study is to establish the safety and effectiveness of the DiamondTemp System for the treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation in patients.
- Trial name
- DIAMOND-AF (NCT03334630)
- Testing
- DiamondTemp Ablation catheter, TactiCath Quartz Ablation catheter
- Where
- 23 sites in United States, Canada and 3 more
- Volunteers
- 482 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Paroxysmal Atrial Fibrillation
Use of the Hansen Medical System in Patients With Paroxysmal Atrial Fibrillation
The purpose of this study is to assess the safety and performance of the Hansen Medical Sensei Robotic System and Artisan Catheter when used to robotically manipulate RF ablation catheters for the treatment of paroxysmal atrial…
- Trial name
- NCT01122173
- Testing
- Ablation
- Where
- 13 sites in United States, Czechia and 3 more
- Volunteers
- 150 people
- Sponsor
- Hansen Medical
Atrial Fibrillation
AtriCure Bipolar Radiofrequency Ablation of Persistent Atrial Fibrillation
ABLATE Persistent is a prospective, non-randomized multi-center clinical trial to demonstrate the safety and effectiveness of the AtriCure Bipolar System for treating persistent atrial fibrillation during concomitant on-pump…
- Trial name
- A (NCT00785902)
- Testing
- AtriCure Bipolar System
- Sponsor
- AtriCure, Inc.
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
- 20 sites in United States
- Volunteers
- 566 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
SOLAR & ATRILAZE Atrial Fibrillation Trial
The purpose of study is to conduct a pivotal evaluation of the EndoPhotonix™ SOLAR™ System and ATRILAZE™ System in order to obtain a labeling claim on the devices for the treatment of atrial fibrillation.
- Trial name
- SAAF-T (NCT00734058)
- Testing
- Laser MAZE by Ablation of Cardiac Tissue
- Volunteers
- 90 people
- Sponsor
- EndoPhotonix, Inc.
Persistent Atrial Fibrillation
A Dual Energy Catheter (PFA and RFA) and a PFA Catheter for the Treatment of PeAF
The goal of this clinical trial is to treatment of patients with persistent atrial fibrillation with PFA/RFA. 10 patients will be treated by PFA/RFA catheter or PFA catheter only.
- Trial name
- PFA，RFA，PeAF (NCT06232798)
- Testing
- a dual energy catheter (RF and PFA) or PFA catheter only will be to treat PeAF,Cardiac Pulsed Electric Field Ablation Catheter, catheter ablation
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.
Atrial Fibrillation
Medtronic Concomitant Utilization of Radio Frequency for Atrial Fibrillation CURE-AF/Persistent
This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the outcome of patients with atrial fibrillation (AF) requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System…
- Trial name
- CURE-AF/Perst (NCT00506493)
- Testing
- Cardioblate Surgical Ablation System, Surgical RF Ablation
- Where
- 15 sites in United States
- Volunteers
- 75 people
- Sponsor
- Medtronic Cardiac Surgery
Atrial Fibrillation
Spanish Registry of Cryoballoon Ablation
The purpose of this registry is to reflect on standard clinical practice in pulmonary vein cryoablation in Spanish hospitals, the different procedure protocols, details of intervention, complications, long-term follow-up strategy…
- Trial name
- RECABA (NCT02785991)
- Testing
- Balloon cryoablation
- Where
- 28 sites in Spain
- Volunteers
- 1,742 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Chronic Atrial Fibrillation
CONVERGE Post-Approval Study (PAS)
The primary objective of CONVERGE PAS is to evaluate clinical outcomes (peri-procedural and long-term) in a cohort of patients treated during commercial use of the EPi-Sense® Guided Coagulation System or EPi-Sense ST™ Coagulation…
- Trial name
- NCT05393180
- Testing
- Epicardial And Endocardial RF Ablation For The Treatment Of Symptomatic Long-standing Persistent AF
- Where
- 13 sites in United States, United Kingdom
- Volunteers
- 53 people
- Sponsor
- AtriCure, Inc.