Clinical trials: Ablation of Atrial Fibrillation
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
Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation
The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation following percutaneous catheter ablation for high risk patients…
- Trial name
- OPTION (NCT03795298)
- Testing
- WATCHMAN FLX Implant, Market-approved OAC
- Where
- 114 sites in United States, Australia and 8 more
- Volunteers
- 1,600 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, 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
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
Substrate Ablation Guided by High Density Mapping in Atrial Fibrillation
To evaluate a new AF Substrate mapping method based on automatic high density CFAE detection with a multipolar catheter (Pentaray) and the " SCI 30-40 " setting of CARTO CFAE algorithm.
- Trial name
- SUBSTRATE-HD (NCT02093949)
- Testing
- Routine substrate ablation without pulmonary vein Isolation, Routine conventional ablation with pulmonary vein Isolation
- Where
- 3 sites in France
- Volunteers
- 152 people
- Sponsor
- Hospital St. Joseph, Marseille, France
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
Atrial Fibrillation Ablation
Vitamin C in Atrial Fibrillation Ablation
Single-center, double-blinded, randomized, controlled safety and feasibility pilot study of high dose IV ascorbic acid (200mg/kg) over 24 hours, divided into four doses and administered every six hours with a 30 minute IV…
- Trial name
- VitC-AF (NCT03148236)
- Testing
- Vitamin C
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Virginia Commonwealth University
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
Paroxysmal Atrial Fibrillation
Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation
This is a demonstration of safety and efficacy of the ablation for pulmonary vein isolation in the treatment of paroxysmal atrial fibrillation.
- Trial name
- NCT00971204
- Testing
- CardioFocus HeartLight Endoscopic Ablation System
- Where
- 10 sites in United States
- Volunteers
- 100 people
- Sponsor
- CardioFocus
Atrial Fibrillation, Atrial Flutter
Evaluation of the Amigo Robotic System for Ablation of the Cavo-Tricuspid Isthmus
The purpose of this study is to compare standard manual and robotically controlled catheter ablation of the cavo-tricuspid isthmus (CTI) as a treatment for atrial flutter.
- Trial name
- Amigo-AFL (NCT02467179)
- Testing
- Amigo™ Robotic Catheter Manipulation, Manual Catheter Manipulation
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of California, San Diego
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
Atrial Fibrillation
DURABLE-I Study: Dielectric Unravelling of Radiofrequency ABLation Effectiveness
The purpose of this study is to evaluate real-time gap detection using EPD D700 dielectric sensing compared with customary electrical isolation tests and Adenosine infusion at the end of the procedure.
- Trial name
- DURABLE-I (NCT02878213)
- Testing
- D700 System
- Where
- Russia
- Volunteers
- 39 people
- Sponsor
- EPD Solutions, A Philips Company
Paroxysmal Atrial Fibrillation
Study of HD Mesh Ablation System for Treatment of Paroxysmal Atrial Fibrillation
This is a randomized controlled study of the Bard High Density Mesh Ablation System for treatment of paroxysmal atrial fibrillation.
- Trial name
- MAGELLAN (NCT00741611)
- Testing
- HD Mesh Ablation System, Anti-arrhythmic drugs
- Where
- 13 sites in United States
- Volunteers
- 44 people
- Sponsor
- C. R. Bard
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, Atrial Fibrillation Recurrent
Effect of Dronedarone on Atrial Fibrosis Progression and Atrial Fibrillation Recurrence
Patients who have undergone cardiac ablation will be randomized and blinded to one of two groups; one group will receive dronedarone while the other group will receive a placebo.
- Trial name
- EDORA (NCT04704050)
- Testing
- dronedarone 400 mg Oral Tablet
- Where
- 4 sites in United States
- Volunteers
- 22 people
- Sponsor
- Tulane University School of Medicine