Clinical trials: Ablation of Atrial Fibrillation
Atrial Fibrillation
A Study to Predict Atrial Fibrillation (AF) Burden in Participants With PAF and PsAF Treated With the VARIPULSE™ PFA Catheter
The purpose of this study is to evaluate how safe VARIPULSE™ Catheter is and how well it works in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF; irregular heartbeat where episodes start and…
- Trial name
- SPECTRA-AF (NCT07788989)
- Testing
- VARIPULSE Catheter System (PVI), VARIPULSE Catheter System (PVI and PWI)
- Volunteers
- 2,300 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation (PAF)
First in Man Study of Pulsed Field Ablation System for the Treatment of Paroxysmal Atrial Fibrillation in 1 Patient
This is the first in man study of CadioPulseTM ( pulsed field ablation system) developed and manufactured by Hangzhou Dinova EP Technology Co., Ltd, which can be used for Pulmonary vein isolation for the treatment of paroxysmal…
- Trial name
- NCT07452211
- Testing
- CardioPulsesTM pulsed field ablation system
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Hangzhou Dinova EP Technology Co., Ltd
Atrial Fibrillation, Surgery
CellFX® nsPFA™ Cardiac Surgery System to Treat Atrial Fibrillation
This feasibility study will be conducted to demonstrate the initial safety and effectiveness of the CellFX® nsPFA™ Cardiac Clamp in performing a box lesion around the 4 pulmonary veins as an isolated procedure or as a part of a…
- Conditions
- Atrial Fibrillation, Surgery, Ablation of Atrial Fibrillation, Clamp Study
- Trial name
- NCT06355063
- Testing
- CellFX® nsPFA™ Cardiac Surgery System
- Where
- 6 sites in Austria, Netherlands and 1 more
- Volunteers
- 30 people
- Sponsor
- Pulse Biosciences, Inc.
Paroxysmal Atrial Fibrillation
IMPACT: A Safety and Feasibility Study of the IOWA Approach Cardiac Ablation System
IMPACT is a prospective, single-arm, multi-center, safety and feasibility study evaluating the IOWA Approach Cardiac Ablation System (FARAPULSE, Inc.) for the treatment of paroxysmal atrial fibrillation.
- Trial name
- IMPACT (NCT03700372)
- Testing
- IOWA Approach Cardiac Ablation System
- Where
- France
- Volunteers
- 7 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
Safety & Performance of the Centauri System for Patients With Atrial Fibrillation
This is a prospective, single-arm, open-label clinical study following patients to 1 year, to evaluate the safety and performance of the Centauri system for catheter ablation of atrial fibrillation (AF).
- Trial name
- SPACE AF (NCT04652778)
- Testing
- Pulsed Field Ablation (PFA) using the Centauri System
- Where
- Canada
- Volunteers
- 15 people
- Sponsor
- Galaxy Medical, Inc.
Paroxysmal Atrial Fibrillation
Clinical Investigation of the VytronUS Ablation System for Treatment of Paroxysmal Atrial Fibrillation
The study is a single center, open-label, single arm, prospective pre-market study designed to assess the safety and efficacy of the VytronUS Ablation System (VAS) for the treatment of atrial fibrillation in patients with drug…
- Trial name
- VALUE (NCT03639597)
- Testing
- VytronUS Ablation System
- Where
- Czechia
- Volunteers
- 53 people
- Sponsor
- VytronUS, Inc.
Atrial Fibrillation (AF)
Measuring Local Potentials in PFA. MULTI PFA (EU)
The study is a prospective, multi-center, exploratory, observational study with the ECGenius® System and the PFAnalyzer software module in PFA cases using the Affera Sphere 9, FaraWave, PulseSelect, Volt or VariPulse PFA systems.
- Trial name
- MULTI PFA (NCT07379697)
- Volunteers
- 30 people
- Sponsor
- CathVision ApS
Atrial Fibrillation
Postmarket Evaluation of the Phased Radio Frequency Ablation System (GOLD AF Registry)
Prospective, multi-center, single-arm, non-interventional and open-label registry. The purpose of the registry is to document use of Phased Radio Frequency Ablation (RFA) (hereafter "Phased RFA") System in a real world patient…
- Trial name
- NCT02433613
- Where
- 41 sites in France, Georgia and 12 more
- Volunteers
- 1,071 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
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
Longstanding Persistent Atrial Fibrillation
Evaluation of the Cardioblate CryoFlex Surgical Ablation System in Longstanding Persistent Atrial Fibrillation
Studies have shown that taking drugs to stay out of AF has limited success. This research is designed to study heart rhythm after surgical therapy, namely by measuring if there are benefits to having surgery to treat Atrial…
- Trial name
- CRYO-AF (NCT01558635)
- Testing
- Cardioblate CryoFlex Surgical Ablation, Mitral Valve surgery, Medtronic Reveal XT Insertable Cardiac Monitor
- Where
- 4 sites in Germany, Israel and 2 more
- Volunteers
- 17 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
ADVENT Post Approval Study
The ADVENT Post Approval Study (PAS) is a prospective, global, multicenter, observational study.
- Trial name
- ADVENTPAS (NCT06431815)
- Testing
- FARAPULSE™ Pulsed Field Ablation System
- Where
- 30 sites in United States, Brazil and 2 more
- Volunteers
- 228 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
Prospective Clinical Study of the Guidant Microwave Ablation System for the Treatment of PAF in the MIS Procedure
The purpose of this prospective, single-arm, un-blinded, multi-site clinical study is to assess the safety and efficacy of the Microwave Ablation System for the treatment of symptomatic paroxysmal atrial fibrillation (PAF) in the…
- Trial name
- NCT00415558
- Testing
- Microwave Ablation System
- Where
- 5 sites in United States
- Sponsor
- Maquet Cardiovascular
Atrial Fibrillation
Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation
The purpose of this study is to provide clinical data pertaining to the safety and performance of the Globe Mapping and Pulsed Field Ablation System for treating subjects with atrial fibrillation (AF).
- Trial name
- PULSE-EU (NCT05164107)
- Testing
- Globe Mapping and Pulsed Field Ablation System (Globe PF System)
- Where
- Czechia
- Volunteers
- 175 people
- Sponsor
- Kardium Inc.
Atrial Fibrillation
Evaluation of the Incidence of Cerebral Lesions Post Pulmonary Vein Ablation Catheter (PVAC)
The purpose of the study is to determine the rate of diffusion weighted (DW)-MRI cerebral lesions following a Pulmonary Vein Ablation Catheter (PVAC) ablation procedure performed using best practices, including optimized…
- Trial name
- ERACE (NCT01520532)
- Testing
- Magnetic Resonance Imaging (MRI)
- Where
- 7 sites in Belgium, Canada and 3 more
- Volunteers
- 60 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Persistent Atrial Fibrillation
A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects With Persistent Atrial Fibrillation
The objective of the ADVANTAGE AF Study is to establish the safety and effectiveness of the FARAPULSE Pulsed Field Ablation System (FARAPULSE PFA System) for treatment of drug resistant, symptomatic persistent atrial fibrillation…
- Trial name
- ADVANTAGE AF (NCT05443594)
- Testing
- Phase 1: FARAPULSE Ablation System, Phase 2: FARAPULSE Ablation System
- Where
- 44 sites in United States, Belgium and 2 more
- Volunteers
- 669 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
Is Endothelial Function a Predictor of Successful Ablation Therapy Provided to Patients With Atrial Fibrillation?
The purpose of this study is to assess whether normal endothelial function in patients with Atrial Fibrillation undergoing ablation procedure increases the chances of a favorable clinical outcome and maintaining sinus rhythm…
- Trial name
- NCT02129842
- Where
- 6 sites in United States, Germany and 2 more
- Volunteers
- 150 people
- Sponsor
- Itamar-Medical, Israel
Atrial Fibrillation, Persistent Atrial Fibrillation
Feasibility Study of the FARAFLEX Mapping and PFA System
The objective of this feasibility study is to evaluate the safety and effectiveness of the FARAFLEX mapping and pulsed field ablation (PFA) catheter, a novel catheter in treating persistent atrial fibrillation (PersAF) or…
- Conditions
- Atrial Fibrillation, Persistent Atrial Fibrillation, Paroxysmal AF
- Trial name
- ELEVATE-PF (NCT06510556)
- Testing
- FARAFLEX Ablation Treatment, ELEVATE-COR Sub-study
- Where
- 4 sites in Belgium, Croatia and 2 more
- Volunteers
- 250 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, Atrial Arrhythmia
VOLta Medical AI-software in REal-World During AF Ablation
This PMCF study "VOLTAIRE-AF" will allow to observe acute and long-term safety and performance outcomes of the last generation of Volta Medical AI software (Volta AF-Xplorer II) during AF ablation using next-generation mapping…
- Conditions
- Atrial Fibrillation, Atrial Arrhythmia, Arrhythmias, Cardiac
- Trial name
- VOLTAIRE-AF (NCT07621055)
- Testing
- Cardiac mapping
- Where
- 3 sites in France
- Volunteers
- 150 people
- Sponsor
- Volta Medical
Atrial Fibrillation
Esophagus Deviation During Radiofrequency Ablation of Atrial Fibrillation - EASY AF STUDY
To assess if deviating the esophagus will reduce/eliminate ablation injury to the esophagus.
- Trial name
- NCT04659213
- Testing
- esolution catheter
- Where
- United States
- Volunteers
- 129 people
- Sponsor
- S4 Medical