Clinical trials: Atrial Fibrillation Paroxysmal
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
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.
Paroxysmal Atrial Fibrillation
THERMOCOOL SMARTTOUCH®SF Catheters With Ablation Index Study
A single-center, real word study of consecutive subjects who undergo radiofrequency ablation for paroxysmal AF using THERMOCOOL SMARTTOUCH®SF (STSF) Catheter guiding by Ablation Index (AI).
- Trial name
- STSF (NCT03963349)
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Biosense Webster, Inc.
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.
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
Sick Sinus Syndrome, Paroxysmal Atrial Fibrillation
Optimal Sensing in Atrial Tachyarrhythmia's Study
The aim of the study is the comparison of two different leads in their capabilities to detect episodes and duration of paroxysmal atrial fibrillation (AF) and atrial tachyarrhythmia (AT), and the rejection of far field sensing of…
- Trial name
- OSAT (NCT01074749)
- Testing
- Accent Pacemaker
- Where
- Netherlands
- Volunteers
- 111 people
- Sponsor
- Abbott Medical Devices
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
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
AF Septal Pacing (Clinical Investigation Plan)
The purpose of this non-randomized, non-controlled, acute, single-arm research study is to evaluate the feasibility to obtain a stable position of a ring of stimulation electrodes on the interatrial septum.
- Trial name
- NCT03242941
- Testing
- Pulmonary vein ablation
- Where
- 3 sites in Hungary, Netherlands
- Volunteers
- 16 people
- Sponsor
- Medtronic BRC
Atrial Fibrillation, Paroxysmal or Persistent, Mitral Valve Disease
Safety and Efficacy of the CoolCryo System for Cardiac Cryoablation in the Treatment of Atrial Fibrillation
The study involves endocardial cryoablation of the left and/or right atrium of the heart using the CoolCryo system as an adjunct to mitral valve surgery, with the aim of eliminating atrial fibrillation (AF), which is a common…
- Trial name
- CoolCryo (NCT06557616)
- Where
- 2 sites in Poland
- Volunteers
- 20 people
- Sponsor
- Medinice S.A.
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.
Scar-related Atrial Tachycardia, Paroxysmal Atrial Fibrillation
A Study Assessing Arrhythmia Mapping With the Multi-Electrode OPTRELL™ Mapping Catheter
The purpose of this study is to assess the performance and safety for the use of the OPTRELL Catheter for intracardiac mapping in the atria and ventricles.
- Conditions
- Scar-related Atrial Tachycardia, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Tachycardia, Ventricular
- Trial name
- OPTIMUM (NCT04983797)
- Testing
- OPTRELL Mapping Catheter
- Where
- 3 sites in Belgium, Lithuania
- Volunteers
- 31 people
- Sponsor
- Biosense Webster, Inc.
Non-valvular Paroxysmal, Persistent, or Permanent Atrial Fibrillation, LAA Anatomy Amenable to Treatment by Percutaneous Technique
Coherex WAVECREST I Left Atrial Appendage Occlusion Study
Purpose To establish the safety and efficacy of the Coherex WaveCrest Left Atrial Appendage Occlusion System for left atrial appendage (LAA) closure during treatment of non-valvular atrial fibrillation in patients who are at…
- Conditions
- Non-valvular Paroxysmal, Persistent, or Permanent Atrial Fibrillation, LAA Anatomy Amenable to Treatment by Percutaneous Technique, Anticoagulation Indication for Potential Thrombus Formation in the Left Atrium
- Trial name
- NCT02239887
- Testing
- WaveCrest LAA occlusion device
- Volunteers
- 155 people
- Sponsor
- Coherex Medical
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
Paroxysmal Atrial Fibrillation (PAF)
Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation
The purpose of this study is to establish the safety and effectiveness of the Blazer Open-Irrigated radiofrequency ablation catheter for the treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation.
- Trial name
- ZERO-AF (NCT01687166)
- Testing
- Blazer Open-Irrigated Ablation Catheter (Boston Scientific), FDA Approved Open-Irrigated Ablation Catheter
- Where
- 38 sites in United States, Australia and 7 more
- Volunteers
- 398 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation Paroxysmal, Cardiac Ablation
NS-PFA Catheter Ablation of Paroxysmal Atrial Fibrillation With the Pulse Biosciences CellFX System
The objective of this study is to demonstrate the safety and effectiveness of the CellFX nano-second Pulsed Field Ablation (nsPFA) Cardiac Catheter Ablation System in treating recurrent, drug-resistant, symptomatic paroxysmal…
- Conditions
- Atrial Fibrillation Paroxysmal, Cardiac Ablation, Cardiac Arrhythmia
- Trial name
- NANOPULSE-AF (NCT07018596)
- Testing
- CellFX nsPFA Cardiac Catheter System
- Where
- Czechia
- Volunteers
- 215 people
- Sponsor
- Pulse Biosciences, Inc.
Atrial Fibrillation, Atrial Fibrillation, Persistent
RESOLVE-AF: Clinical Evaluation of the Ablacath™ Mapping Catheter and Ablamap® System Utilizing Electrographic Flow (EGF) Mapping to Resolve Extra-PV Sources of Atrial Fibrillation and Guide Ablation Therapy.
Demonstrate the safety and effectiveness of the Ablacath™ Mapping Catheter and Ablamap® System in patients with all types of atrial fibrillation (AF) including paroxysmal or persistent or long-standing persistent, undergoing and…
- Conditions
- Atrial Fibrillation, Atrial Fibrillation, Persistent, Atrial Fibrillation Paroxysmal, Arrhythmia
- Trial name
- RESOLVE-AF (NCT05883631)
- Testing
- Electrographic Flow (EGF) mapping and ablation of EGF-identified sources of Atrial Fibrillation, Electrographic Flow (EGF) mapping (no ablation)
- Where
- 24 sites in United States, Belgium and 2 more
- Volunteers
- 400 people
- Sponsor
- Cortex
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.
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
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
Electrical Coupling Information From The RHYTHMIA HDx Mapping System and DIRECTSENSE Technology In The Treatment of Paroxysmal Atrial Fibrillation (LOCALIZE CF)
The objective of this study is to evaluate whether local impedance (DIRECTSENSE™) drop on the INTELLANAV STABLEPOINT™ ablation catheter is associated with late pulmonary vein (PV) reconnections and durable conduction block in…
- Trial name
- LOCALIZE CF (NCT04740801)
- Testing
- Ablation procedure
- Where
- 5 sites in Germany, Italy and 1 more
- Volunteers
- 60 people
- Sponsor
- Boston Scientific Corporation