Clinical trials: Atrial Fibrillation (Paroxysmal)
Atrial Fibrillation, Atrial Flutter
iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
A prospective, single-arm, multi-center study designed to collect real world safety and performance data of the Adagio Medical iCLAS Cryoablation System in the treatment of drug refractory, recurrent, symptomatic, Paroxysmal…
- Conditions
- Atrial Fibrillation, Atrial Flutter, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
- Trial name
- NCT05416086
- Testing
- cryoablation procedure using the iCLAS Cryoablation System
- Where
- 4 sites in Belgium, Germany and 1 more
- Volunteers
- 91 people, healthy volunteers welcome
- Sponsor
- Adagio Medical
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
Paroxysmal Atrial Fibrillation
Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation
To establish the safety and effectiveness of the Boston Scientific Cardiac Cryoablation System for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial fibrillation (AF).
- Trial name
- FROZEN-AF (NCT04133168)
- Testing
- Boston Scientific Cardiac Cryoablation System
- Where
- 44 sites in United States, Belgium and 7 more
- Volunteers
- 458 people
- Sponsor
- Boston Scientific Corporation
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
Paroxysmal Atrial Fibrillation
Ablation of the Pulmonary Veins for Paroxysmal Afib
The purpose of this trial was to investigate and confirm the safety, efficacy, and efficiency of the Ablation Frontiers® Cardiac Ablation System when used in the treatment of paroxysmal atrial fibrillation. (PAF)
- Trial name
- MAP-PAF (NCT00744874)
- Testing
- RF Ablation procedure
- Where
- 5 sites in Denmark, Germany and 2 more
- Volunteers
- 55 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter
The purpose of this study is to assess the performance and safety of using the investigational catheter.
- Conditions
- Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Ventricular Tachycardia
- Trial name
- NCT05970120
- Testing
- NUVISION NAV Ultrasound Catheter
- Where
- 3 sites in Croatia, Israel and 1 more
- Volunteers
- 30 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation
A Prospective Clinical Study to Evaluate the Safety and Effectiveness of Pulmonary Vein Isolation Plus Box Isolation of Fibrotic Areas With the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation
The study will evaluate the safety and 12-month effectiveness of the Pulmonary Vein Isolation plus Box Isolation of Fibrotic Areas (BIFA) ablation strategy with the Globe Pulsed Field System (Globe PF System) for the treatment of…
- Trial name
- GLOBAL-PF (NCT06973031)
- Testing
- Globe Pulsed Field System
- Where
- Germany
- Volunteers
- 115 people
- Sponsor
- Kardium Inc.
Atrial Fibrillation Paroxysmal, Atrial Fibrillation, Persistent
Assert-IQ Implantable Cardiac Monitor (ICM) Post Market Study
This is a prospective, non-randomized, multi-center, real-world post-market study to collect and evaluate data regarding the performance of the enhanced atrial fibrillation detection algorithm of the Assert-IQTM Implantable…
- Conditions
- Atrial Fibrillation Paroxysmal, Atrial Fibrillation, Persistent, Cardiac Arrhythmia, Ablation
- Trial name
- Assert-IQ (NCT06172699)
- Testing
- Holter monitoring in patients who have been successfully implanted with an Abbott Assert-IQ ICM device
- Where
- 11 sites in United States
- Volunteers
- 151 people
- Sponsor
- Abbott Medical Devices
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
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
Paroxysmal Atrial Fibrillation
Oral Anticoagulation Therapy Pilot Study
The objective of this study is to determine the safety of discontinuing oral anticoagulation therapy in high risk patients who have had a successful cardiac ablation and remain AF recurrence free for 3 months post ablation.
- Trial name
- OAT (NCT01959425)
- Testing
- Off OAT Group (Test), On OAT Group (Control)
- Volunteers
- 80 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation
Evaluation of VISITAG SURPOINT™ Module With External Processing Unit (EPU)
Prospective, non-randomized, post market clinical evaluation of the VISITAG SURPOINT™ Module with External Processing Unit (EPU) when used with STSF catheter and ST catheter compared to an historical control performance goal.
- Trial name
- NCT03624881
- Testing
- Catheter ablation with EPU
- Where
- 41 sites in United States
- Volunteers
- 333 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation
Evaluation of the Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal Atrial Fibrillation
This study will evaluate the long-term safety and effectiveness of the Globe® Pulsed Field System for treating patients with symptomatic paroxysmal atrial fibrillation.
- Trial name
- PULSAR PAS (NCT07714876)
- Testing
- Globe Pulsed Field System
- Volunteers
- 250 people
- Sponsor
- Kardium Inc.
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
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
A Study to Predict Atrial Fibrillation (AF) Burden in Participants With PAF and PsAF Treated With the VARIPULSE™ PFA Catheter
The purpose of this study is to evaluate how safe VARIPULSE™ Catheter is and how well it works in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF; irregular heartbeat where episodes start and…
- Trial name
- SPECTRA-AF (NCT07788989)
- Testing
- VARIPULSE Catheter System (PVI), VARIPULSE Catheter System (PVI and PWI)
- Where
- United States
- Volunteers
- 2,300 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation Paroxysmal, Cardiac Ablation
CellFX® Nanosecond Pulsed Field Ablation (PFA) 360 Catheter Ablation System for Treatment of Atrial Fibrillation
The objective of this study is to demonstrate initial safety and effectiveness of the CellFX nano-second Pulsed Field Ablation (nsPFA or nano-PFA) 360 Catheter Endocardial Ablation System in treating subjects with atrial…
- Conditions
- Atrial Fibrillation Paroxysmal, Cardiac Ablation, Cardiac Arrhythmia
- Trial name
- NCT06696170
- Testing
- CellFX nano-pFA 360 Endocardial Ablation Catheter System
- Where
- 3 sites in Belgium, Czechia and 1 more
- Volunteers
- 60 people
- Sponsor
- Pulse Biosciences, Inc.
Atrial Fibrillation
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
The main purpose of this clinical study is to investigate the effectiveness workflow of the clinical use of the pulsed field (PF) ablation system (VARIPULSE™ Catheter and TRUPULSE™ Generator) when used for cardiac ablation with…
- Trial name
- VP-CONFIRM (NCT07429214)
- Testing
- Pulsed Field Ablation System
- Where
- 6 sites in Belgium, Denmark and 3 more
- Volunteers
- 42 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation (AF), Persistant Atrial Fibrillation
Coherent Sine Burst Electroporation (CSE) Ablation System US IDE Study for Patients With Atrial Fibrillation
To evaluate the safety and effectiveness of the Argá Medtech CSE Ablation System in the treatment of atrial fibrillation.
- Conditions
- Atrial Fibrillation (AF), Persistant Atrial Fibrillation, Paroxysmal AF
- Trial name
- COHERENT-AF (NCT06784466)
- Testing
- Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System
- Where
- 27 sites in United States, Belgium and 4 more
- Volunteers
- 360 people
- Sponsor
- Arga Medtech SA
Atrial Fibrillation
A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation
The main purpose of the study is to assess how well the standard ablation procedure (Varipulse Catheter) works over long term when used with different types of anesthesia in participants with symptomatic paroxysmal atrial…
- Trial name
- GreatPFA (NCT07511166)
- Volunteers
- 300 people
- Sponsor
- Johnson & Johnson Medical (Shanghai) Ltd.