Clinical trials: Paroxysmal Arrhythmia
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 (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
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
Post-Market Randomized Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation
To compare the safety and chronic Pulmonary Vein isolation of 2 ablation types. 1. visually guided ablation (VGA) using the EAS-AC and 2. radiofrequency ablation
- Trial name
- En-GARDE (NCT01057394)
- Testing
- Endoscopically guided PVI Ablation, RF PVI Ablation
- Where
- 2 sites in Czechia, Italy
- Volunteers
- 21 people
- Sponsor
- CardioFocus
Atrial Fibrillation
Selective Complex Fractionated Atrial Electrograms (CFAE) Targeting for Atrial Fibrillation
This study will be a multicenter, open, prospective, randomized trial. Patients with either paroxysmal or persistent atrial fibrillation will be considered for the study.
- Trial name
- SELECT-AF (NCT00926783)
- Testing
- CFAE ablation
- Where
- 7 sites in United States, Australia and 1 more
- Volunteers
- 86 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation (PAF)
Sphere-9 PAF China Study
The goal of this clinical trial is to find out if the Sphere-9 Catheter and Affera Integrated Mapping and Ablation System is safe and works to treat recurrent symptomatic paroxysmal atrial fibrillation (PAF) in adults who have…
- Trial name
- NCT07789925
- Testing
- Catheter ablation using Sphere-9™ Catheter and Affera™ Integrated Mapping and Ablation System
- Where
- 10 sites in China
- Volunteers
- 180 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation
Vimecon CAI Trial for the Interventional Treatment of Paroxysmal Atrial Fibrillation (AF)
This study is a prospective, non-randomized, single arm, multicenter, CE marking trial for patients with paroxysmal atrial fibrillation to undergo an ablation of the cardiac tissue near the PV.
- Trial name
- CAI (NCT02770989)
- Testing
- Vimecon Laser CAI percutaneous cardiac ablation
- Where
- 3 sites in Belgium, Czechia and 1 more
- Volunteers
- 1 people
- Sponsor
- Vimecon GmbH
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 Atrial Fibrillation
The FARAPULSE ADVENT PIVOTAL Trial PFA System vs SOC Ablation for Paroxysmal Atrial Fibrillation
This is a prospective, adaptive, multi-center, randomized safety and effectiveness pivotal study comparing the FARAPULSE Pulsed Field Ablation System with standard of care ablation with force-sensing RF catheters and cryoballoon…
- Trial name
- ADVENT (NCT04612244)
- Testing
- FARAPULSE Pulsed Field Ablation System, RadioFrequency and Cryoballoon Ablation
- Where
- 34 sites in United States
- Volunteers
- 706 people
- Sponsor
- Boston Scientific Corporation
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.
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
Rapid Arrhythmia, PFA
Clinical Study on the Safety and Efficacy of a New Magnetic Navigation Radiofrequency Ablation Catheter for Rapid Arrhythmia
Clinical study on the safety and efficacy of FireMagic™ Magbot Ablation Catheter for rapid arrhythmia
- Conditions
- Rapid Arrhythmia, PFA, Symptomatic Supraventricular Tachycardia
- Trial name
- Rapid arrhythm (NCT07067372)
- Testing
- FireMagic™ Magbot Ablation Catheter
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.
Paroxysmal AF
CENTAURI Post-Market Clinical Registry
The objective of this post-market clinical registry is to collect realworld clinical experience across multiple European centers regarding the safety and efficacy of the CENTAURI System
- Trial name
- CENTAURI Regis (NCT07874048)
- Testing
- CENTAURI System in conjunction with commercially available ablation catheters
- Volunteers
- 300 people
- Sponsor
- CardioFocus
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 Fibrillation, Paroxysmal Atrial Fibrillation
FIRE AND ICE Re-Ablations (Retrospective Data Collection)
Retrospective data collection on re-ablations performed within the FIRE AND ICE Trial.
- Trial name
- Re-Do (NCT03314753)
- Testing
- No interventions - retrospective data collection
- Where
- 13 sites in Czechia, France and 4 more
- Volunteers
- 89 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
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
3-Dimensional Mapping System: The PULSTAR Study
The purpose of this study is to verify the safety and efficacy of the cardiac pulse ablation system in paroxysmal atrial fibrillation to provide the basis for product registration and clinical application.
- Trial name
- NCT05618340
- Testing
- Pulsed electric field ablation device;Cardiac Pulsed Electric Field Ablation Catheter
- Where
- China
- Volunteers
- 149 people
- Sponsor
- Shanghai Shangyang Medical Technology Co., Ltd.
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.
Atrial Fibrillation (AF), Paroxysmal AF
PulseMagic™ TrueForce™ PAF NMPA Study
This clinical investigation is intended to demonstrate safety and effectiveness of the PulseMagic™ TrueForce™ Ablation Catheter and the PulseMagic™Pulse Field Ablation (PFA) Generator, and Columbus™ 3D EP Navigation System with…
- Conditions
- Atrial Fibrillation (AF), Paroxysmal AF, Drug Refractory Paroxysmal Atrial Fibrillation, Atrial Arrhythmia
- Trial name
- PFATrueForce (NCT07720557)
- Testing
- PFA Ablation catheter
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.
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.