Clinical trials: Atrial Fibrillation, Paroxysmal
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
Ventricular Tachycardia (VT), Atrial Tachycardia
Clinical Study on the Efficiency of Rapid Arrhythmia Mapping Using EasyStars™ High Density Mapping Catheter Applications
The primary objective of this study was to evaluate the clinical feasibility, safety, and surgical characteristics of the EasyStars™ High Density Mapping Catheterin in patients with complex arrhythmias.
- Conditions
- Ventricular Tachycardia (VT), Atrial Tachycardia, Typical Atrial Flutter, Paroxysmal Atrial Fibrillation (PAF)
- Trial name
- Rapid Arrhythm (NCT07079813)
- Testing
- EasyStars™ High Density Mapping Catheter
- Volunteers
- 300 people
- Sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.
Paroxysmal Atrial Fibrillation
Multi-electrode Radiofrequency Balloon Catheter Use for the Isolation of the Pulmonary Veins.
This clinical investigation is a prospective, multicenter, single arm clinical evaluation utilizing the multi-electrode radiofrequency balloon catheter and the multi-electrode circular diagnostic catheter.
- Trial name
- SHINE (NCT03437733)
- Testing
- Radiofrequency Ablation
- Where
- 5 sites in Czechia, Italy and 1 more
- Volunteers
- 98 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation
A Blinded Study to Evaluate Effect on Atrial Fibrillation Burden in Patients With Paroxysmal Atrial Fibrillation
The purpose of this study is to evaluate the effect of BMS-919373 on atrial fibrillation (AF) through its effect on AF burden (AFB), or the percent of time in AF, in subjects with paroxysmal AF (pAF) when administered orally at a…
- Trial name
- NCT02156076
- Testing
- BMS-919373
- Where
- 35 sites in United States, Canada
- Volunteers
- 158 people
- Sponsor
- Bristol-Myers Squibb
Paroxysmal Atrial Fibrillation
Treatment of PAF With the Synaptic System
Enrolled subjects will be treated with the Synaptic Cryoablation System. Treatment will include cryoablation of the pulmonary veins to achieve PVI.
- Trial name
- Sensation (NCT05905835)
- Testing
- Synaptic Cryoablation System
- Where
- 10 sites in United States
- Volunteers
- 128 people
- Sponsor
- Synaptic Medical Corporation
Paroxysmal Atrial Fibrillation
Guided Radiofrequency Ablation Using the CARTO® 3 and NavX™ Systems for the Treatment of Paroxysmal Atrial Fibrillation
The purpose of this study is to determine the change in median radiation exposure time and median procedure time following guided radiofrequency (RF) ablation among subjects undergoing treatment for paroxysmal atrial fibrillation…
- Trial name
- CO1 (NCT01036724)
- Testing
- Cardiac Mapping
- Where
- 6 sites in Canada
- Volunteers
- 107 people
- Sponsor
- Biosense Webster, Inc.
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.
Drug Refractory Paroxysmal Atrial Fibrillation
A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic PAF
The purpose of this study is to demonstrate safety and effectiveness of the Biosense Webster (BWI) ablation system (THERMOCOOL SMARTTOUCH surround flow [STSF] catheter and TRUPULSE generator) when used for isolation of the atrial…
- Trial name
- SMARTPULSE PAF (NCT06144632)
- Testing
- THERMOCOOL STSF Bi- Directional Navigation Catheter, TRUPULSE Generator
- Where
- 29 sites in United States
- Volunteers
- 237 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation
Clinical Evaluation of Therapy™ Cool Flex Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation
The purpose of this study is to observe the performance of Therapy™ Cool Flex™ catheter by documenting the procedural parameters, major complications and recurrence of AF after ablation using Cool Flex ablation catheter for the…
- Trial name
- FACT-AF (NCT01185613)
- Testing
- Therapy™ Cool Flex Ablation Catheter
- Where
- 6 sites in Australia, France and 4 more
- Volunteers
- 50 people
- Sponsor
- Abbott Medical Devices
Paroxysmal AF
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
The study is a prospective, single-arm, pre-market clinical study and will enroll up to 300 subjects at up to 26 sites in the United States (US) for analysis of primary objectives.
- Trial name
- Horizon 360 (NCT07308847)
- Testing
- Sphere-360 Pulsed Field Ablation Catheter with the Affera Mapping and Ablation System
- Where
- 24 sites in United States
- Volunteers
- 300 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Paroxysmal Atrial Fibrillation
PEFCATII Expanded Safety and Feasibility Study of the FARAPULSE Endocardial Multi Ablation System to Treat Paroxysmal Atrial Fibrillation
PEFCAT II: Expanded Safety and Feasibility Study of the FARAPULSE Endocardial Multi Ablation System to Treat Paroxysmal Atrial Fibrillation
- Trial name
- PEFCATII (NCT04170608)
- Testing
- FARAPULSE Endocardial Multi Ablation System
- Where
- 2 sites in Croatia, Czechia
- Volunteers
- 10 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal Atrial Fibrillation
Oral Anticoagulation Therapy Pilot Study
The objective of this study is to determine the safety of discontinuing oral anticoagulation therapy in high risk patients who have had a successful cardiac ablation and remain AF recurrence free for 3 months post ablation.
- Trial name
- OAT (NCT01959425)
- Testing
- Off OAT Group (Test), On OAT Group (Control)
- Volunteers
- 80 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE)
The primary objective is to demonstrate safety and long-term effectiveness of the irreversible electroporation (IRE) system (Circular IRE Catheter and IRE Generator) when used for isolation of the atrial pulmonary veins (PVs) in…
- Trial name
- inspIRE (NCT04524364)
- Testing
- Pulsed Field Ablation (PFA) Therapy
- Where
- 13 sites in Austria, Belgium and 6 more
- Volunteers
- 272 people
- Sponsor
- Biosense Webster, Inc.
Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation
ABLATE Post Approval Study - Synergy Ablation Lesions for Non-Paroxysmal Atrial Fibrillation
The primary objective of this post-approval study is to evaluate the clinical outcomes in a cohort of patients with non-paroxysmal forms of atrial fibrillation (persistent or long-standing persistent) treated during commercial…
- Trial name
- ABLATE-PAS (NCT01694563)
- Testing
- Synergy Ablation System
- Where
- 49 sites in United States
- Volunteers
- 365 people
- Sponsor
- AtriCure, Inc.
Paroxysmal Atrial Fibrillation
GENESIS Feasibility Study of the BARD Over-the-Wire Mesh Ablation System for the Treatment of Paroxysmal Atrial Fibrillation
The Genesis Feasibility Study will collect clinical information on the use of the Bard Over-the-Wire Mesh Ablation System to access and perform electrophysiological mapping, cardiac stimulation and radiofrequency ablation in the…
- Trial name
- GENESIS (NCT01430949)
- Testing
- Catheter Ablation of Paroxysmal Atrial Fibrillation
- Where
- 6 sites in Canada, Germany and 1 more
- Volunteers
- 42 people
- Sponsor
- C. R. Bard
Heart Diseases, Arrhythmia
NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation
This trial compares the safety and effectiveness of catheter ablation for PAF with antiarrhythmic drug therapy. The investigational catheter being studied is the NAVISTAR® THERMOCOOL® irrigated-tip catheter.
- Conditions
- Heart Diseases, Arrhythmia, Atrial Fibrillation
- Trial name
- Afib IDE (NCT00116428)
- Testing
- NAVISTAR® THERMOCOOL® Catheter, Antiarrhythmic drug
- Where
- 17 sites in United States, Brazil and 3 more
- Volunteers
- 167 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.
Atrial Arrhythmia, Atrial Fibrillation
VOLT CE Mark Study
This clinical investigation is intended to demonstrate safety and effectiveness of the Volt™ Pulsed Field Ablation (PFA) Catheter Sensor Enabled™, the Volt™ PFA Generator, Agilis™ NxT Steerable Introducer Dual-Reach™, and EnSite™…
- Conditions
- Atrial Arrhythmia, Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
- Trial name
- NCT06106594
- Testing
- Pulsed Field Ablation
- Where
- 11 sites in Australia, Austria and 5 more
- Volunteers
- 300 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
A Dose-range Finding Study of MAA868 in Patients With Atrial Fibrillation
This study is a multicenter, randomized, subject and Investigator-blinded, placebo-controlled, parallel-group, multiple ascending dose-ranging study to evaluate the safety, tolerability, pharmacokinetics (PK), and…
- Trial name
- NCT04213807
- Testing
- MAA868 Cohort 1, MAA868 Cohort 2, MAA868 Cohort 3
- Where
- 6 sites in United States
- Volunteers
- 28 people
- Sponsor
- Anthos Therapeutics, Inc.
Atrial Fibrillation
STAR-AF:Substrate Versus Trigger Ablation for Reduction of Atrial Fibrillation Trial
Patient Population: Patients with AF that is symptomatic and refractory to at least one antiarrhythmic medication. Patients must have AF that is paroxysmal (>4 episodes within 6 months, two episodes >6 hours within 1 year) or…
- Trial name
- NCT00367757
- Testing
- Ablate AF triggers via PVI, Substrate via CFAEs, Combined approach for AF ablation
- Where
- 8 sites in Canada, Italy and 2 more
- Volunteers
- 107 people
- Sponsor
- Abbott Medical Devices