Clinical trials: Ablation of Atrial Fibrillation
Atrial Fibrillation (AF)
From the Emergency Department Directly to Ablation of Atrial Fibrillation Study
The study is a prospective, two-arm, randomized, open-label, blinded endpoint, multi-center study to investigate the impact of first line ablation in patients presenting at the emergency room with recent-onset paroxysmal or…
- Trial name
- EMERGE-Cryo (NCT05294445)
- Testing
- Ablation of atrial fibrillation (AF)
- Where
- 13 sites in Germany
- Volunteers
- 350 people
- Sponsor
- Asklepios proresearch
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Evaluation of Novel Waveforms Delivered Using the FARAPULSE™ PFA System
This is a multicenter, prospective, single-arm, feasibility study to evaluate the safety and effectiveness of the waveforms being delivered using the FARAPULSE PFA System in patients with Paroxysmal Atrial Fibrillation (PAF) and…
- Trial name
- IMPULSE-EVO (NCT07444320)
- Testing
- FARAPULSE™ Pulsed Field Ablation (PFA) System
- Where
- 4 sites in Croatia, Czechia and 2 more
- Volunteers
- 200 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
Safety and Performance of the SpherePVI™ Catheter to Treat Paroxysmal Atrial Fibrillation
A prospective, single-arm, single-center study to evaluate the safety, performance, and effectiveness of the SpherePVI™ Catheter for treating paroxysmal AF.
- Trial name
- SpherePVI (NCT05144503)
- Testing
- SpherePVI™ Catheter
- Where
- Lithuania
- Volunteers
- 100 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Automated Assessment of PVI Using a Novel EP Recording System
A prospective, multi-center study with the CathVision Cube® system and the PVI Analyzer software in radiofrequency (RF), cryo-balloon (CB), and Pulse Field Ablation (PFA) procedures.
- Trial name
- PVISION (NCT05043883)
- Testing
- CathVision Cube® system
- Where
- 4 sites in Belgium, France
- Volunteers
- 101 people
- Sponsor
- CathVision ApS
Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation
Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With FIRM Guided Procedures
A prospective, multicenter, randomized study to assess the safety and effectiveness of FIRM-guided procedures in conventional "redo" RF ablation procedures for the treatment of persistent and paroxysmal atrial fibrillation.
- Trial name
- REDO-FIRM (NCT02799043)
- Testing
- Standard PVI, FIRM-Guided Procedure and PVI
- Where
- 24 sites in United States, Belgium and 2 more
- Volunteers
- 269 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Atrial Fibrillation
A Study of the Safety and Efficacy of the VytronUS Low-Intensity Collimated Ultrasound Ablation System
The objective of this investigation is to evaluate whether pulmonary vein isolation using the VytronUS ablation system is safe and effective acutely and at 3 months.
- Trial name
- NCT01900678
- Testing
- VytronUS Ablation System
- Where
- Czechia
- Volunteers
- 7 people
- Sponsor
- VytronUS, Inc.
Atrial Fibrillation, Pulsed Field Ablation
A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation
The study is designed to collect data on the acute and long-term (1 year) safety and effectiveness outcome when an ablation procedure is performed in a commercial and standard of care setting with the FARAPULSE™ Pulsed Field…
- Conditions
- Atrial Fibrillation, Pulsed Field Ablation, FARAPULSE
- Trial name
- OPALISE (NCT06808217)
- Testing
- FARAPULSE Pulsed Field Ablation System
- Where
- 22 sites in Austria, France and 8 more
- Volunteers
- 550 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
Uninterrupted Dabigatran Etexilate in Comparison to Uninterrupted Warfarin in Pulmonary Vein Ablation (RE-CIRCUIT)
The primary objective of this trial is to assess the safety of an uninterrupted dabigatran etexilate periprocedural anticoagulant regimen compared to an uninterrupted warfarin regimen in Non-Valvular Atrial Fibrillation (NVAF)…
- Trial name
- NCT02348723
- Testing
- Warfarin, Dabigatran Etexilate 150mg
- Where
- 87 sites in United States, Belgium and 9 more
- Volunteers
- 678 people
- Sponsor
- Boehringer Ingelheim
Paroxysmal Atrial Fibrillation
Clinical Evaluation of Therapy™ Cool Flex Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation
The purpose of this study is to observe the performance of Therapy™ Cool Flex™ catheter by documenting the procedural parameters, major complications and recurrence of AF after ablation using Cool Flex ablation catheter for the…
- Trial name
- FACT-AF (NCT01185613)
- Testing
- Therapy™ Cool Flex Ablation Catheter
- Where
- 6 sites in Australia, France and 4 more
- Volunteers
- 50 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Atrial Fibrillation
Reduction of AF Ablation Induced Thrombo-Embolic Incidence Pilot Study
The REDUCE-TE Pilot study is an international, multicenter, prospective, single arm study to compare the AlCath Flux eXtra Gold ablation catheter regarding the prevention of new subclinical cerebral thromboembolic lesions after…
- Trial name
- NCT02275260
- Testing
- Cerebral Diffusion-Weighted Magnetic Resonance Imaging, Transesophageal Echocardiography, Paperbased neurocognitive testing
- Where
- 14 sites in Czechia, Germany and 3 more
- Volunteers
- 110 people
- Sponsor
- Biotronik SE & Co. KG
Atrial Fibrillation
Vimecon CAI Trial for the Interventional Treatment of Paroxysmal Atrial Fibrillation (AF)
This study is a prospective, non-randomized, single arm, multicenter, CE marking trial for patients with paroxysmal atrial fibrillation to undergo an ablation of the cardiac tissue near the PV.
- Trial name
- CAI (NCT02770989)
- Testing
- Vimecon Laser CAI percutaneous cardiac ablation
- Where
- 3 sites in Belgium, Czechia and 1 more
- Volunteers
- 1 people
- Sponsor
- Vimecon GmbH
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
Ganglionated Plexus Ablation For Treatment of Atrial Fibrillation
This study evaluates the effect of catheter ablation of ganglionated plexi (GP) for the treatment of adult patients with atrial fibrillation heart arrhythmias.
- Trial name
- NCT02267889
- Testing
- Image guided GP ablation, D-SPECT dedicated cardiac nuclear camera
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Spectrum Dynamics
Atrial Fibrillation, Persistent, Atrial Fibrillation
AF-FLOW Registry to Evaluate Electrographic Flow Mapping in Patients Undergoing Ablation for Atrial Fibrillation
This post-market global registry will evaluate the ability of Electrographic Flow (EGF™) mapping to identify atrial fibrillation (AF) sources and guide ablation therapy in patients with atrial fibrillation in real-world setting.
- Conditions
- Atrial Fibrillation, Persistent, Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases
- Trial name
- NCT05481359
- Testing
- Electrographic Flow™ (EGF) mapping and ablation
- Where
- 5 sites in United States, Netherlands and 1 more
- Volunteers
- 25 people
- Sponsor
- Ablacon, Inc.
Atrial Fibrillation
Assessment of the Utility of BIOMONITOR to Identify Atrial Fibrillation (AF) in Ablation Candidates Using Precise AF Detection
The purpose of this study is to evaluate the diagnostic utility of BIOTRONIK's subcutaneous cardiac rhythm monitor for the detection of AF prior to an ablation procedure.
- Trial name
- BIO-Precision (NCT04076917)
- Where
- 5 sites in United States
- Volunteers
- 84 people
- Sponsor
- Biotronik, Inc.
Atrial Fibrillation
AtriCure Minimally Invasive Surgical Ablation for Atrial Fibrillation/RESTORE IIB
Feasibility study arm to evaluate the safety of adding the left atrial linear connecting lesions of the Cox-Maze lesion set to the current RESTORE SR II IDE study procedure of performing pulmonary vein isolation, selected left…
- Trial name
- RESTORE SR IIB (NCT00571779)
- Testing
- AtriCure Bipolar System
- Sponsor
- AtriCure, Inc.
Atrial Fibrillation, Atrial Flutter
Assessment of the Sphere-9™ Catheter and Affera Mapping and Ablation System for Treatment of Atrial and Ventricular Arrhythmias
A prospective, single-arm, multi-center, safety and performance assessment of the Sphere-9™ Catheter and the Affera Mapping and RF Ablation System to treat Atrial Arrhythmias
- Conditions
- Atrial Fibrillation, Atrial Flutter, Ventricular Tachycardia
- Trial name
- NCT04211441
- Testing
- Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System
- Where
- 2 sites in Czechia
- Volunteers
- 74 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation
FLAT Study: First Line Ablation Therapy for Treatment of Paroxysmal Atrial Fibrillation (RAAFT)
The objective of this multicenter randomized study is to establish the effectiveness of treatment for paroxysmal atrial fibrillation (AF), in patients not previously treated with anti-arrhythmic drugs, by encircling the pulmonary…
- Trial name
- NCT00137540
- Testing
- RF ablation, anti-arrhythmic drug therapy
- Volunteers
- 40 people
- Sponsor
- Biosense Webster EMEA
Atrial Fibrillation, Atrial Flutter
FREEZE-AFIB Post-Market Study
This study is proposed herein is to gather clinical data on the safety and performance of the CRYOF device.
- Trial name
- NCT05089877
- Testing
- Surgical Ablation
- Where
- 6 sites in United States
- Volunteers
- 39 people
- Sponsor
- AtriCure, Inc.
Paroxysmal Atrial Fibrillation
Clinical Investigation of the VytronUS Ablation System for Treatment of Symptomatic Drug-refractory Paroxysmal Atrial Fibrillation
VITAL is a prospective, single arm, multicenter, interventional study to evaluate the safety and effectiveness of the VytronUS Ablation System (VAS) for the treatment of symptomatic paroxysmal atrial fibrillation (PAF) using low…
- Trial name
- VITAL (NCT03513029)
- Testing
- VytronUS Ablation System
- Where
- Czechia
- Volunteers
- 100 people
- Sponsor
- VytronUS, Inc.