Clinical trials: Atrial Fibrillation Ablation
Atrial Fibrillation
Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF
The study is a prospective, multi-center, non-randomized, unblinded worldwide pre-market clinical study. The purpose of the study is to provide data demonstrating the safety and effectiveness of the PulseSelect™ PFA System for…
- Trial name
- PULSED AF (NCT04198701)
- Testing
- Medtronic PulseSelect Pulsed Field Ablation (PFA) System
- Where
- 41 sites in United States, Australia and 7 more
- Volunteers
- 421 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Paroxysmal Atrial Fibrillation, Atrial Fibrillation
DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation
The purpose of the DIAMOND-AF study is to establish the safety and effectiveness of the DiamondTemp System for the treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation in patients.
- Trial name
- DIAMOND-AF (NCT03334630)
- Testing
- DiamondTemp Ablation catheter, TactiCath Quartz Ablation catheter
- Where
- 23 sites in United States, Canada and 3 more
- Volunteers
- 482 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
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.
Atrial Fibrillation, Persistent or Longstanding Persistent Atrial Fibrillation
Pivotal Study Of A Dual Epicardial & Endocardial Procedure (DEEP) Approach
The objective of this study is to establish the safety and effectiveness of a dual epicardial and endocardial ablation procedure for patients presenting with Persistent Atrial Fibrillation or Longstanding Persistent Atrial…
- Trial name
- DEEP (NCT02393885)
- Testing
- AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation
- Where
- 17 sites in United States, Belgium and 1 more
- Volunteers
- 90 people
- Sponsor
- AtriCure, Inc.
Atrial Fibrillation
AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation
ABLATE is a prospective, non-randomized multi-center clinical trial to demonstrate the safety and effectiveness of the AtriCure Bipolar System for treating permanent atrial fibrillation during concomitant on-pump cardiac surgery.
- Trial name
- ABLATE (NCT00560885)
- Testing
- AtriCure Bipolar System
- Where
- 9 sites in United States
- Volunteers
- 55 people
- Sponsor
- AtriCure, Inc.
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
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
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
INtra-procedural ultraSound Imaging During Pulmonary Veins Isolation
One of the biggest limitations of the currently used percutaneous techniques for Pulmonary Vein Isolation (PVI) in the setting of atrial fibrillation ablation is the lack of real-time information about the left atrial (LA) wall…
- Trial name
- INSIDEPVs (NCT03372798)
- Testing
- ICE/IVUS imaging during atrial fibrillation ablation
- Where
- United Kingdom
- Volunteers
- 14 people
- Sponsor
- Oxford University Hospitals NHS Trust
Atrial Fibrillation, Heart Failure
AV Node Ablation and Pacemaker Therapy Compared to Drug Therapy for Atrial Fibrillation - Pilot Study
The purpose of this study is to determine whether early atrioventricular node (AVN) ablation with pacing device therapy will reduce death and hospitalization when compared to the conventional drug therapy in elderly patients with…
- Trial name
- PACIFIC (NCT00589303)
- Testing
- FDA approved rate and rhythm control drugs, AV Node ablation and device implant
- Where
- 6 sites in United States, Canada
- Volunteers
- 27 people
- Sponsor
- Mayo Clinic
Atrial Fibrillation, Atrial Flutter
Comparison of Intracardiac Echocardiography and Transesophageal Echocardiography
The presence of intracardiac thrombi and their propensity for systemic embolism is a major concern in patients with atrial fibrillation (AF) and atrial flutter (AFL) undergoing cardioversion and ablation procedures.
- Trial name
- ICE-TEE (NCT02213666)
- Testing
- Intracardiac Imaging
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- Elad Anter
Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation
A Feasibility Study to Evaluate the Effect of Concomitant Renal Denervation and Cardiac Ablation on AF Recurrence
The purpose of this post market clinical investigation is to complete preliminary evaluation on whether or not concomitant renal denervation with the EnligHTN™ Renal Denervation System and cardiac ablation will result in improved…
- Conditions
- Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Hypertension
- Trial name
- RDN+AF (NCT01907828)
- Testing
- Renal Artery Ablation, Cardiac Ablation
- Where
- 2 sites in Germany
- Volunteers
- 61 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Atrial Flutter
An Initial Assessment of the Sphere-9™ Catheter and Affera Mapping and Ablation System
A prospective, single-arm, multi-center, safety and performance assessment of the Sphere-9™ Catheter and the Affera Mapping and Ablation System to treat Atrial Arrhythmias
- Trial name
- NCT04210622
- Testing
- Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System
- Where
- Lithuania
- Volunteers
- 16 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
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.
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
Paroxysmal Atrial Fibrillation
Ectopy Triggering Ganglionated Plexus Ablation to Prevent Atrial Fibrillation
Atrial fibrillation (AF) is a common heart rhythm disorder which can significantly affect a patient's quality of life and cause strokes.
- Trial name
- GANGLIA-AF (NCT02487654)
- Testing
- Pulmonary vein isolation, Ganglionated plexus ablation
- Where
- 3 sites in United Kingdom
- Volunteers
- 116 people
- Sponsor
- Imperial College London
Atrial Fibrillation
Mapping Electrogram Morphology Recurrence for Atrial Fibrillation Ablation
The overall goal of this project is to test the feasibility of performing real-time electrogram morphology recurrence (EMR) mapping in patients with persistent atrial fibrillation (AF) to locate areas of high electrogram…
- Trial name
- NCT03082963
- Testing
- Electrogram Morphology Mapping (EMR)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Jeffrey Goldberger
Persistent Atrial Fibrillation
Modified Ablation Guided by Ibutilide Use in Chronic Atrial Fibrillation
Procedures for ablation of persistent or long lasting atrial fibrillation are frequently long and require extensive ablation. Some electrophysiologists administer the drug ibutilide during these procedures to help organize the…
- Trial name
- MAGIC-AF (NCT01014741)
- Testing
- Ibutilide
- Where
- 7 sites in United States, Canada and 1 more
- Volunteers
- 200 people
- Sponsor
- Vivek Reddy
Paroxysmal Atrial Fibrillation
Guided Radiofrequency Ablation Using the CARTO® 3 and NavX™ Systems for the Treatment of Paroxysmal Atrial Fibrillation
The purpose of this study is to determine the change in median radiation exposure time and median procedure time following guided radiofrequency (RF) ablation among subjects undergoing treatment for paroxysmal atrial fibrillation…
- Trial name
- CO1 (NCT01036724)
- Testing
- Cardiac Mapping
- Where
- 6 sites in Canada
- Volunteers
- 107 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
Femoral Vein Hemostasis After Ablation for Atrial Fibrillation With Manual Pressure Versus a Figure of 8 Suture
Patients who undergo ablation for AF typically have 2 sheaths placed in each groin, including a large sheath when the Cryo Balloon is used for pulmonary vein isolation.
- Trial name
- Figure 8 (NCT03040661)
- Testing
- Ablation for atrial fibrillation.
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Inova Health Care Services