Clinical trials: Ablation of Atrial Fibrillation
Atrial Fibrillation, Esophageal Fistula
Retracting the Esophagus During AF Ablation
This Study is designed to determine the outcome and effect of implementation of Esophageal Stylet as a strategy to minimize the risk of esophageal injury during the atrial fibrillation catheter ablation procedure.
- Conditions
- Atrial Fibrillation, Esophageal Fistula, Cardiac Arrhythmia
- Trial name
- EsoSure (NCT02665442)
- Testing
- Esophageal Stylet - EsoSure
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Northeast Scientific, 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
Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial - Star AF II Study
This investigation is designed with the hypothesis that combined PV Antral Isolation and Ablation of Complex Fractionated Electrograms (PVI+CFE) approach will offer a higher success rate compared to the Wide Circumferential…
- Trial name
- Star AF II (NCT01203748)
- Testing
- PVI + Lines ablation, PVI, PVI + CFE ablation
- Where
- 2 sites in Australia, Canada
- Volunteers
- 589 people
- Sponsor
- Abbott Medical Devices
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
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
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
Safety-and-effectiveness Clinical Evaluation of Nanosecond-pulse Ablation for Atrial Fibrillation
This study is expected to include 166 subjects and Conducted at 11 research centers；The expected 12 month treatment success rate of using research instruments is 65%. Principle evaluation indexes： 1.
- Trial name
- SCENA-AF (NCT06039722)
- Testing
- Pulse ablation catheter
- Where
- China
- Volunteers
- 166 people
- Sponsor
- Shenzhen Pulsecare Medical Technology Co., Ltd.
Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation
A Prospective Clinical Study to Evaluate the Safety and Effectiveness of Pulmonary Vein Isolation Plus Box Isolation of Fibrotic Areas With the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation
The study will evaluate the safety and 12-month effectiveness of the Pulmonary Vein Isolation plus Box Isolation of Fibrotic Areas (BIFA) ablation strategy with the Globe Pulsed Field System (Globe PF System) for the treatment of…
- Trial name
- GLOBAL-PF (NCT06973031)
- Testing
- Globe Pulsed Field System
- Where
- Germany
- Volunteers
- 115 people
- Sponsor
- Kardium Inc.
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
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
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.
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
Paroxysmal Atrial Fibrillation
A Single Arm Pilot Study of Pulsed Field Ablation in the Treatment of Paroxysmal Atrial Fibrillation
The objective of this pilot study is to confirm that endocardial ablation using the FARAPULSE Ablation System Plus with commercial design devices is both safe and effective for treating drug-resistant paroxysmal atrial…
- Trial name
- FARA-Free (NCT04474054)
- Testing
- Catheter ablation to treat paroxysmal atrial fibrillation
- Where
- Croatia
- Volunteers
- 15 people
- Sponsor
- Boston Scientific Corporation
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
Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation
Outcomes of an Optimized Workflow With PulseSelect Pulsed Field Ablation (PFA) System in Paroxysmal and Persistent Atrial Fibrillation
The NEXT PULSE study is a pre-market, prospective, multi-center, non-randomized, interventional clinical study. Adult subjects with symptomatic paroxysmal or persistent AF who provided consent will be enrolled and treated with…
- Trial name
- NEXT PULSE (NCT07575828)
- Testing
- PulseSelect Pulse Field Ablation (PFA) System
- Volunteers
- 320 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Paroxysmal Atrial Fibrillation
Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation.
The QDOT-FAST study is a prospective, multi-center, non-randomized, interventional clinical study.
- Trial name
- QDOT-FAST (NCT03459196)
- Testing
- THERMOCOOL SMARTTOUCH SF-5D Catheter
- Where
- 7 sites in Austria, Belgium and 2 more
- Volunteers
- 54 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
Performance and Safety of the Globe® Mapping and Ablation System With the GPS™ Module for the Treatment of Atrial Fibrillation
This study will evaluate the safety and acute performance of the Globe® Mapping and Ablation System with the GPS™ Module intended to conduct electroanatomic mapping and ablation treatment of subjects with atrial fibrillation (AF).
- Trial name
- GPS-CA (NCT04486924)
- Testing
- Globe Mapping and Ablation System
- Where
- 2 sites in Canada
- Volunteers
- 18 people
- Sponsor
- Kardium Inc.
Atrial Fibrillation, Atrial Flutter
FREEZE-AFIB Post-Market Study
This study is proposed herein is to gather clinical data on the safety and performance of the CRYOF device.
- Trial name
- NCT05089877
- Testing
- Surgical Ablation
- Where
- 6 sites in United States
- Volunteers
- 39 people
- Sponsor
- AtriCure, Inc.
Atrial Fibrillation
A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF)
The purpose of this study is to demonstrate the safety and 12-month effectiveness of the BWI OMNYPULSE™ pulsed field ablation (PFA) platform for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic…
- Trial name
- OMNY-AF (NCT06455098)
- Testing
- OMNYPULSE™ Catheter with the TRUPULSE Generator
- Where
- 41 sites in United States, Australia
- Volunteers
- 354 people
- Sponsor
- Biosense Webster, Inc.
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