Clinical trials: Atrial Fibrillation Catheter Ablation
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.
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
Heart Diseases
Transseptal Needle Versus Radiofrequency Energy for Left Atrial Access
This is a randomized controlled trial examining whether a mechanical needle versus a needle that uses radiofrequency energy is better at puncturing through a thin wall in the heart (called "transseptal puncture") as measured by…
- Trial name
- TRAVERSE-LA (NCT01209260)
- Testing
- Radiofrequency energy needle, Mechanical Needle
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- University of California, San Francisco
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
Atrial Fibrillation
Treatment of Persistent Atrial Fibrillation With Sphere-9 Catheter and Affera Mapping and Ablation System
This is a prospective, multicenter, randomized clinical evaluation of the Sphere-9 Mapping and Ablation Catheter with the Affera Mapping and Ablation System.
- Trial name
- SPHERE Per-AF (NCT05120193)
- Testing
- Mapping and Ablation
- Where
- 23 sites in United States, Czechia and 1 more
- Volunteers
- 477 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
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
Left Atrial Mechanical Function Improvement After Atrial Fibrillation Catheter Ablation
The objective of the study was to estimate the efficacy of telmisartan and amlodipine combination on the restoration of left atrial mechanical function after atrial fibrillation catheter ablation.
- Trial name
- NCT02734355
- Testing
- Telmisartan 80 mg and amlodipine 5 mg
- Volunteers
- 64 people
- Sponsor
- Research Institute for Complex Problems of Cardiovascular Diseases, Russia
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
Apixaban Evaluation of Interrupted Or Uninterrupted Anticoagulation for Ablation of Atrial Fibrillation
The purpose of the prospective, randomized cohort in this study is to assess the safety and efficacy of 2 apixaban treatment strategies (uninterrupted versus interrupted) in subjects planned to undergo catheter ablation for the…
- Trial name
- AEIOU (NCT02608099)
- Testing
- Interrupted apixaban, Uninterrupted apixaban
- Where
- 19 sites in United States
- Volunteers
- 300 people
- Sponsor
- Baim Institute for Clinical Research
Uncontrolled Hypertension, Atrial Fibrillation
Adjunctive Renal Denervation in the Treatment of Atrial Fibrillation
The objective of the H-FIB trial is to determine the role of renal sympathetic denervation in the prevention of Atrial Fibrillation (AF) recurrence in patients with hypertension for whom a catheter-based AF ablation procedure is…
- Trial name
- H-FIB (NCT01635998)
- Testing
- Boston Scientific Vessix Renal Denervation System
- Where
- 8 sites in United States, Czechia and 1 more
- Volunteers
- 50 people
- Sponsor
- Vivek Reddy
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
Atrial Fibrillation
Comparison of Percutaneous Closure to Manual Compression for Hemostasis
This a prospective randomized trial occurring in patients undergoing routine ablation for atrial fibrillation as standard of care.
- Trial name
- NCT04180540
- Testing
- Percutaneous Closure, Manual Compression
- Where
- 2 sites in United States
- Volunteers
- 109 people
- Sponsor
- Michael S. Lloyd
Persistent Atrial Fibrillation, Atrial Fibrillation
DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation
The purpose of the Diamond-AF II study is to establish the safety and effectiveness of the DiamondTemp Ablation System for the treatment of drug refractory, symptomatic persistent atrial fibrillation in patients.
- Trial name
- Diamond-AFII (NCT03643224)
- Testing
- Radiofrequency Ablation
- Where
- 28 sites in United States, Canada and 4 more
- Volunteers
- 376 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation
Microfidelity (MIFI) Ablation Technology Versus Standard Ablation Catheter for Atrioventricular Nodal Ablation
The aim of our study is to investigate the comparative efficacy of high fidelity multi electrode ablation catheters vs the standard bipolar configuration in success of AV nodal ablation This study will provide insights on the use…
- Trial name
- NCT03114124
- Testing
- MIFI Catheter, Standard Ablation Catheter
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of Florida
Persistent Atrial Fibrillation
Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation
This clinical investigation is intended to demonstrate the safety and effectiveness of the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for use in cardiac electrophysiological mapping and for the…
- Trial name
- NCT03650556
- Testing
- TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™
- Where
- 22 sites in United States, Australia
- Volunteers
- 224 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
Recording for Potential AF Drivers and Patient Specific Atrial Anatomy & Atrial Electrogram Maps
The 64 pole basket catheter used for the mapping procedure will be defined "atypical" sites which sustain atrial fibrillation. The ablation through the driver will lead to more rapid ablation of the atrial fibrillation.
- Trial name
- CONFIRM (NCT01581437)
- Testing
- 64 pole basket catheter
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- Virginia Commonwealth University
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.
Paroxysmal Atrial Fibrillation
The FARAPULSE FARA-Freedom Trial
The Post-Market Clinical Follow-Up trial is a prospective, multi-center, open-label, single-arm clinical follow-up study designed to provide long-term safety feasibility, effectiveness and performance of the FARAPULSE Pulsed…
- Trial name
- FARA-Freedom (NCT05072964)
- Testing
- FARAPULSE Pulsed Field Ablation System
- Where
- 13 sites in Belgium, Czechia and 4 more
- Volunteers
- 180 people
- Sponsor
- Boston Scientific Corporation