Clinical trials: Ablation of Atrial Fibrillation
Atrial Fibrillation, Tachycardia, Supraventricular
TOCCATA - Touch+™ for Catheter Ablation
The main objective of this study is to demonstrate the clinical safety of a contact force sensing RF ablation catheter when used for the treatment of supraventricular tachycardia and atrial fibrillation.
- Trial name
- TOCCATA (NCT01223469)
- Testing
- Contact force assisted irrigated RF ablation
- Volunteers
- 77 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation (Paroxysmal), Paroxysmal AF
3-Dimensional Mapping System: The PULSTAR II Study
### Study Overview Study Name In simple terms, this study involves using a new device to treat a heart condition called "Paroxysmal Atrial Fibrillation." Sponsor The study is sponsored by a company called Shanghai Shangyang…
- Conditions
- Atrial Fibrillation (Paroxysmal), Paroxysmal AF, Pulsed Field Ablation
- Trial name
- PAF (NCT07586176)
- Testing
- Nanosecond pulsed electric field ablation system; Cardiac Pulsed Electric Field Ablation Catheter
- Where
- China
- Volunteers
- 152 people
- Sponsor
- Shanghai Shangyang Medical Technology Co., Ltd.
Atrial Fibrillation
Guidant Microwave Ablation System for the Treatment of Atrial Fibrillation
The purpose of the Randomized Study of Surgical Ablation with Microwave Energy for the Treatment of Atrial Fibrillation (RESOLVE-AF) trial is to determine the safety and effectiveness of the Guidant FLEX® Microwave Surgical…
- Trial name
- NCT00111488
- Testing
- Flex 4 and Generator
- Where
- 21 sites in United States
- Volunteers
- 200 people
- Sponsor
- Boston Scientific Corporation
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
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.
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.
Atrial Fibrillation, Persistent or Longstanding Persistent Atrial Fibrillation
Pivotal Study Of A Dual Epicardial & Endocardial Procedure (DEEP) Approach
The objective of this study is to establish the safety and effectiveness of a dual epicardial and endocardial ablation procedure for patients presenting with Persistent Atrial Fibrillation or Longstanding Persistent Atrial…
- Trial name
- DEEP (NCT02393885)
- Testing
- AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation
- Where
- 17 sites in United States, Belgium and 1 more
- Volunteers
- 90 people
- Sponsor
- AtriCure, Inc.
Atrial Fibrillation
Concomitant Treatment of Permanent Atrial Fibrillation
RESTORE-SR study is a multi-center, prospective, nonrandomized study with case matched concurrent controls to evaluate the safety and efficacy of the AtriCure Bipolar System
- Trial name
- RESTORE SR (NCT00566787)
- Testing
- Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
- Where
- 10 sites in United States
- Volunteers
- 39 people
- Sponsor
- AtriCure, Inc.
Atrial Fibrillation, Atrial Flutter
An Initial Assessment of the Sphere-9™ Catheter and Affera Mapping and Ablation System
A prospective, single-arm, multi-center, safety and performance assessment of the Sphere-9™ Catheter and the Affera Mapping and Ablation System to treat Atrial Arrhythmias
- Trial name
- NCT04210622
- Testing
- Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System
- Where
- Lithuania
- Volunteers
- 16 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation
Safety & Clinical Performance Study of Catheter Ablation With the Centauri System for Patients With Atrial Fibrillation
This study is a prospective, single-arm, open-label 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
- ECLIPSE AF (NCT04523545)
- Testing
- cardiac ablation
- Where
- Croatia
- Volunteers
- 200 people
- Sponsor
- Galaxy Medical, Inc.
Paroxysmal Atrial Fibrillation
Evaluation of the Safety and Efficacy of the CardioPulseTM PuLsed fiEld Ablation SystEm in Patients With Paroxysmal Atrial Fibrillation (PLEASE-AF Study)
The purpose of this clinical trial is to evaluate the safety and efficacy of a pulsed field ablation system developed and manufactured by Hangzhou Dinova EP Technology Co., Ltd in the treatment of patients with paroxysmal atrial…
- Trial name
- NCT05114954
- Testing
- CardioPulsesTM pulsed field ablation system
- Where
- China
- Volunteers
- 158 people
- Sponsor
- Hangzhou Dinova EP Technology Co., Ltd
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
RandOmised Controlled Trial of STAR Mapping™ Guided Ablation for AF.
Atrial fibrillation (AF) is the most common arrhythmia with an expected rise in prevalence over the next decade. Beyond causing troublesome symptoms AF is associated with increased mortality and morbidity.
- Trial name
- ROC-STAR (NCT04442113)
- Testing
- Pulmonary vein isolation plus ablation guided by novel STAR mapping™, Pulmonary vein isolation
- Sponsor
- Rhythm AI Ltd
Atrial Fibrillation
PulseSelect™ PFA Global Registry
The PulseSelect™ PFA Global Registry is a prospective, global, multi-center, observational post-approval study. Subjects will be treated with the PulseSelect™ PFA System and followed according to SOC.
- Trial name
- NCT06393920
- Where
- 43 sites in Australia, Belgium and 14 more
- Volunteers
- 1,950 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Cardiac Arrhythmia
An Evaluation of the Safety and Performance of the CathVision ECGenius® System.
The primary objective is to evaluate the safety and technical performance of the CathVision ECGenius® System. The secondary objective is to benchmark the intracardiac electrogram signal quality compared to commercially available…
- Trial name
- NCT05301803
- Testing
- Electrophysiology procedure
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- CathVision ApS
Atrial Fibrillation
Efficacy and Safety Study on Agilis NxT Introducer in AF Patients
To prove if the success rate of curative treatment of atrial fibrillation in left atrial circumferential pulmonary vein ablation is higher by using a steerable transseptal introducer giving access to the left atrium then by using…
- Trial name
- AGILIS (NCT00469638)
- Testing
- Left atrial catheter ablation guided by introducer using Agilis sheeth, Left atrial catheter ablation guided by introducer using Non-steerable sheeth
- Where
- Germany
- Volunteers
- 130 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Atrial Fibrillation (PAF)
Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS)
The Post-Approval Study (PAS) is a prospective multi-center, non-randomized, single arm, controlled,unblinded clinical study designed to provide long-term safety and effectiveness of the Arctic Front® Cardiac CryoAblation System.
- Trial name
- STOP AF PAS (NCT01456949)
- Testing
- Medtronic Arctic Front® Cardiac CryoAblation System
- Where
- 39 sites in United States, Canada
- Volunteers
- 402 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation, Tachycardia
Long-Standing Persistant Atrial Fibrillation-Pulmonary Vein Isolation With or Without Ablation
The chronic success rate, defined as freedom from any atrial tachyarrhythmias will increase from 35% to 60% by ablation of complex fragmented atrial electrograms potentials in addition to pulmonary vein isolation (PVI) as…
- Trial name
- Alster-Lost (NCT00820625)
- Testing
- pulmonary vein isolation, pulmonary vein isolation with additional ablation of fragmented potentials
- Where
- Germany
- Volunteers
- 124 people
- Sponsor
- Asklepios proresearch
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.
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.