Clinical trials: Atrial Fibrillation Paroxysmal
Paroxysmal Atrial Fibrillation
Prospective Evaluation of Open Irrigated Ablation Catheters With High Resolution Mapping to Treat Paroxysmal Atrial Fibrillation
To obtain data for the Rhythmia™ Mapping System in conjunction with Boston Scientific Open-Irrigated (OI) Catheters for ablation of Paroxysmal Atrial Fibrillation (PAF) according to current international and local guidelines.
- Trial name
- INTERRUPT AF (NCT03729830)
- Testing
- Boston Scientific Open Irrigated Ablation Catheters
- Where
- 26 sites in United States, Germany and 4 more
- Volunteers
- 415 people
- Sponsor
- Boston Scientific Corporation
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.
Refractory Paroxysmal Atrial Fibrillation
A Study of Multi-electrode Circular Irreversible Electroporation (IRE) Catheter and Multi-Channel IRE Generator in Paroxysmal Atrial Fibrillation (AF)
The purpose of this study is to evaluate the long term off-Antiarrhythmic Drug (AAD) effectiveness of Biosense Webster, Inc. Irreversible Electroporation (BWI IRE) system in treatment of participants with symptomatic drug…
- Trial name
- AFIRE (NCT05552963)
- Testing
- Multi-Channel Irreversible Electroporation (IRE) Generator, Multi-Channel Circular IRE Catheter
- Where
- 6 sites in China
- Volunteers
- 142 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation
POLARx™ Cardiac Cryoablation System Post Market Clinical Study (POLAR SMART)
This is a post-market study collecting real-world clinical data on safety, effectiveness and procedural success of Boston Scientific Cardiac Cryoablation System (POLARx™ System)
- Trial name
- POLAR SMART (NCT05282823)
- Testing
- Boston Scientific Cardiac Cryoablation System
- Where
- 19 sites in Japan, South Korea
- Volunteers
- 295 people
- Sponsor
- Boston Scientific Corporation
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, Paroxysmal Atrial Fibrillation
Feasibility Study on the FARAVIEW Technology
The purpose of this study is to gather data regarding the utilization of the FARAVIEW™ feature of the RHYTHMIA HDx Mapping System when used in conjunction with the FARAWAVE NAV Pulsed Field Ablation catheter in subjects…
- Conditions
- Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
- Trial name
- NAVIGATE PF (NCT06175234)
- Testing
- Ablation Treatment
- Where
- 3 sites in Czechia, Ireland and 1 more
- Volunteers
- 50 people
- Sponsor
- Boston Scientific Corporation
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
Arrhythmias, Cardiac, Paroxysmal Atrial Fibrillation
InsightPFA Trial of the LotosPFA Catheter
This trial aims to determine whether the InsightPFA for PVI is as effective and safe as standard RFA in the treatment of symptomatic paroxysmal AF.
- Trial name
- InsightPFA (NCT06014996)
- Testing
- Pulsed Field Ablation (PFA) Therapy, Radiofrequency Ablation（RAF）Therapy
- Where
- 10 sites in China
- Volunteers
- 292 people
- Sponsor
- Insight Medtech 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
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.
Obstructive Sleep Apnea (OSA), Atrial Fibrillation (Paroxysmal)
Rhythm Express Wearable System vs. Simultaneous Polysomnography for the Diagnosis of Obstructive Sleep Apnea in Adults With Suspected or Observed Atrial Fibrillation
The goal of this observational study is to confirm the accuracy of the sleep algorithm (software) used in the Rhythm Express Wearable System to detect sleep apnea severity.
- Conditions
- Obstructive Sleep Apnea (OSA), Atrial Fibrillation (Paroxysmal), Palpitations
- Trial name
- NCT06907888
- Testing
- Rhythm Express Wearable System
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- VivaQuant
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
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.
Paroxysmal Atrial Fibrillation (PAF)
A Clinical Study on the Use of a Domestically Produced Cryoablation System Combined With Balloon Cryoablation Technology for the Treatment of Paroxysmal Atrial Fibrillation
To validate the safety and efficacy of balloon cryoablation technology and the accompanying disposable intracardiac mapping electrode catheter and adjustable guide sheath for the treatment of paroxysmal atrial fibrillation.
- Trial name
- Balloon cryoab (NCT07036068)
- Testing
- IceMagic™ CryoAblation Catheter
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.
Paroxysmal Atrial Fibrillation (PAF)
A Clinical Study on the Use of a Domestically Produced Three-dimensional Cardiac Electrophysiological Mapping System Combined With Pressure Monitoring Technology and Star Mapping Technology for the Treatment of Paroxysmal Atrial Fibrillation.
Validating the safety and efficacy of pressure monitoring technology and star-shaped marking technology for the treatment of paroxysmal atrial fibrillation
- Trial name
- paroxysmal at (NCT07039032)
- Testing
- FireMagic™ Magbot Ablation Catheter 、FireMagic™ TrueForce™ Ablation Catheter
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.
Paroxysmal Atrial Fibrillation
Evaluation of Ablation Index and VISITAG™ (ABI-173)
The purpose of this study is to assess the safety, acute and long term effectiveness, during standard RF ablation procedures while using Ablation Index and VISITAG™ software in combination with a Thermocool SmartTouch® (ST) or…
- Trial name
- VISTAX (NCT03062046)
- Testing
- RF ablation
- Where
- 17 sites in Austria, Belgium and 7 more
- Volunteers
- 340 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.
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.
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter
The purpose of this study is to assess the performance and safety of using the investigational catheter.
- Conditions
- Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Ventricular Tachycardia
- Trial name
- NCT05970120
- Testing
- NUVISION NAV Ultrasound Catheter
- Where
- 3 sites in Croatia, Israel and 1 more
- Volunteers
- 30 people
- Sponsor
- Biosense Webster, Inc.