Clinical trials: Atrial Fibrillation Paroxysmal
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
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
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.
Atrial Fibrillation
Study to Evaluate the Effect of Ranolazine and Dronedarone When Given Alone and in Combination in Patients With Paroxysmal Atrial Fibrillation
The primary objective of this study is to evaluate the effect of ranolazine and of low-dose dronedarone when given alone and in combination at different dose levels on atrial fibrillation burden (AFB) over 12 weeks of treatment.
- Trial name
- HARMONY (NCT01522651)
- Testing
- Ranolazine, Dronedarone
- Where
- 50 sites in United States, Germany and 5 more
- Volunteers
- 134 people
- Sponsor
- Gilead Sciences
Atrial Fibrillation, Paroxysmal Atrial Fibrillation
Ascending Dose Study of OPC-108459 Intravenous Infusions in Patients With Paroxysmal and Persistent Atrial Fibrillation
The purpose of Part 1 of this study is to determine the maximally tolerated dose of OPC-108459 in patients with paroxysmal and persistent atrial fibrillation (AF).
- Conditions
- Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
- Trial name
- CADENCE 215 (NCT01483183)
- Testing
- OPC-108459
- Where
- 25 sites in United States, Germany and 4 more
- Volunteers
- 40 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
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.
Sleep Disordered Breathing, Sleep Apnea
Effect of Treatment of Sleep Apnea in Patients With Paroxysmal Atrial Fibrillation
Atrial fibrillation (AF) is the most common cardiac rhythm disturbance in adults, with prevalence expected to rise significantly the coming decades.
- Conditions
- Sleep Disordered Breathing, Sleep Apnea, Paroxysmal Atrial Fibrillation
- Trial name
- NCT02727192
- Testing
- PAP (CPAP or ASV)
- Where
- Norway
- Volunteers
- 109 people
- Sponsor
- Oslo University Hospital
Paroxysmal Atrial Fibrillation
NAVISTAR® THERMOCOOL® Catheter Post Approval Registry
The purpose of this registry is to provide additional corroborative short-term safety and long-term safety data for the NAVISTAR THERMOCOOL and NAVISTAR EZ STEER THERMOCOOL catheters in the treatment of symptomatic Paroxysmal…
- Trial name
- AF Registry (NCT00964392)
- Testing
- Atrial fibrillation ablation
- Volunteers
- 437 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
Continued Access Protocol
This Continued Access Protocol has been written to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the Arctic Front® Cryoablation System is under review.
- Trial name
- CAP-AF (NCT00889681)
- Testing
- Arctic Front Cardiac Cryoablation System
- Where
- 10 sites in United States
- Volunteers
- 81 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Paroxysmal Atrial Fibrillation
Use of the Hansen Medical System in Patients With Paroxysmal Atrial Fibrillation
The purpose of this study is to assess the safety and performance of the Hansen Medical Sensei Robotic System and Artisan Catheter when used to robotically manipulate RF ablation catheters for the treatment of paroxysmal atrial…
- Trial name
- NCT01122173
- Testing
- Ablation
- Where
- 13 sites in United States, Czechia and 3 more
- Volunteers
- 150 people
- Sponsor
- Hansen Medical
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
High-Density (HD) Wave Mapping in Subjects With Atrial Fibrillation as a Predictor of Recurrence After a Single Ablation Procedure Using a PVI-Only Strategy
The aim is to use the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ to characterize the atrial substrate and develop a model for predicting recurrence rates after a single procedure using a PVI only approach and a contact…
- Conditions
- Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Cardiac Arrhythmia
- Trial name
- WAVE-MAP AF (NCT03882021)
- Testing
- A specific electrophysiology mapping protocol is applicable with the GRID catheter.
- Where
- 15 sites in Austria, Czechia and 7 more
- Volunteers
- 300 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Atrial Fibrillation
A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation
This study (STOP AF) is a prospective, randomized, controlled, multicenter, pivotal clinical investigation conducted at 26 investigational sites in the United States and Canada.
- Trial name
- Stop-AF (NCT00523978)
- Testing
- Arctic Front® Cryoablation Catheter, Flecainide or Sotalol or Propafenone
- Where
- 26 sites in United States, Canada
- Volunteers
- 245 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation
Adenosine to Assess Complete Conduction Block During Catheter Ablation of Paroxysmal Atrial Fibrillation
The purpose of this study is to determine if additional ablation during the first procedure as the result of the ability to medically induce quiet atrial arrhythmias will improve clinical outcome in patients with atrial…
- Trial name
- NCT03032965
- Testing
- Adenosine, Isoproterenol
- Where
- United States
- Volunteers
- 131 people
- Sponsor
- University of Michigan
Heart Diseases, Arrhythmia
NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation- Treatment Use Study
This trial evaluates the safety and effectiveness of catheter ablation for PAF. The investigational catheter being studied is the NAVISTAR® THERMOCOOL® irrigated-tip catheter.
- Conditions
- Heart Diseases, Arrhythmia, Atrial Fibrillation
- Trial name
- AFTX (NCT00721149)
- Testing
- Radiofrequency Ablation
- Volunteers
- 10 people
- Sponsor
- Biosense Webster, Inc.
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
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.
Atrial Fibrillation
Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
The primary objective of this clinical investigation is to demonstrate safety and effectiveness of the Multi-Electrode RF Balloon catheter for the treatment of drug refractory symptomatic paroxysmal atrial fibrillation.
- Trial name
- STELLAR (NCT03683030)
- Testing
- Multi-Electrode RF Balloon Catheter
- Where
- 41 sites in United States, China and 1 more
- Volunteers
- 397 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation, Persistent Atrial Fibrillation
ECGi Ibutilide: Effect of Ibutilide on AF Source Location and Organization
This is a prospective, multi-center, non-randomized, un-blinded, observational trial.
- Trial name
- NCT03370536
- Testing
- CardioInsight ECGI Mapping System, AF ablation, Ibutilide
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Vivek Reddy
Atrial Fibrillation
SMART China, A Multi-center Clinical Registry Study
This is a prospective effectiveness and safety assessment of the study device during radiofrequency (RF) ablation treatment of patients with drug refractory symptomatic atrial fibrillation.
- Trial name
- NCT02485925
- Testing
- THERMOCOOL® SMARTTOUCH™
- Volunteers
- 200 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
Effect of Structural Remodeling on Scar Formation as Assessed by DE-MRI of the Left Atrium
The purpose of this study is to evaluate the impact of pre-ablation fibrosis on scar formation in the left atrium of the heart. This will be assessed by delayed enhancement magnetic resonance imaging and will be looked at in…
- Trial name
- RADAR (NCT01187914)
- Volunteers
- 40 people
- Sponsor
- University of Utah