Clinical trials: Drug Refractory Paroxysmal Atrial Fibrillation
Atrial Fibrillation
STAR-AF:Substrate Versus Trigger Ablation for Reduction of Atrial Fibrillation Trial
Patient Population: Patients with AF that is symptomatic and refractory to at least one antiarrhythmic medication. Patients must have AF that is paroxysmal (>4 episodes within 6 months, two episodes >6 hours within 1 year) or…
- Trial name
- NCT00367757
- Testing
- Ablate AF triggers via PVI, Substrate via CFAEs, Combined approach for AF ablation
- Where
- 8 sites in Canada, Italy and 2 more
- Volunteers
- 107 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
nMARQ™ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation
To demonstrate safety and effectiveness of nMARQ Catheter System [nMARQ] compared with THERMOCOOL® Navigational Family of catheters in treating subjects with drug-refractory symptomatic paroxysmal atrial fibrillation (PAF).
- Trial name
- NCT01824394
- Testing
- nMARQ Navigation Catheters, NaviStar ThermoCool Catheters
- Volunteers
- 481 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation.
Atrial Fibrillation: Ablation or Surgical Treatment II: FAST II
The purpose of this study is to compare two invasive treatments of symptomatic paroxysmal atrial fibrillation: Percutaneous radiofrequency catheter ablation and mini invasive thoracoscopic radiofrequency ablation in patients…
- Trial name
- NCT01336075
- Testing
- Percutaneous radiofrequency catheter ablation, Mini invasive thoracoscopic radiofrequency ablation
- Where
- 3 sites in Denmark, Netherlands
- Volunteers
- 26 people
- Sponsor
- Aalborg University Hospital
Paroxysmal Atrial Fibrillation
The Long-term Safety and Effectiveness Evaluation of the QDOT MICRO System Use in Conjunction With VISITAG SURPOINT Module for the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation.
Observational, multi-center, non-randomized, post-market study. This is a nested sub-study of the REAL AF Registry. Consecutive symptomatic drug refractory paroxysmal atrial fibrillation (PAF) patients from the registry will be…
- Trial name
- QDOT PAS (NCT06324201)
- Testing
- Ablation Procedure
- Where
- 21 sites in United States
- Volunteers
- 250 people
- Sponsor
- Heart Rhythm Clinical and Research Solutions, LLC
Paroxysmal Atrial Fibrillation
Treatment of PAF With the Synaptic System
Enrolled subjects will be treated with the Synaptic Cryoablation System. Treatment will include cryoablation of the pulmonary veins to achieve PVI.
- Trial name
- Sensation (NCT05905835)
- Testing
- Synaptic Cryoablation System
- Where
- 10 sites in United States
- Volunteers
- 128 people
- Sponsor
- Synaptic Medical Corporation
Drug Refractory Paroxysmal Atrial Fibrillation
A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic PAF
The purpose of this study is to demonstrate safety and effectiveness of the Biosense Webster (BWI) ablation system (THERMOCOOL SMARTTOUCH surround flow [STSF] catheter and TRUPULSE generator) when used for isolation of the atrial…
- Trial name
- SMARTPULSE PAF (NCT06144632)
- Testing
- THERMOCOOL STSF Bi- Directional Navigation Catheter, TRUPULSE Generator
- Where
- 29 sites in United States
- Volunteers
- 237 people
- Sponsor
- Biosense Webster, Inc.
Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation CONTINUED ACCESS
This is a prospective, multicenter, non-randomized continued access clinical evaluation utilizing the THERMOCOOL® SMARTTOUCH™ catheter.
- Trial name
- NCT01639495
- Testing
- THERMOCOOL® SMARTTOUCH™ Catheter
- Where
- 20 sites in United States
- Volunteers
- 148 people
- Sponsor
- Biosense Webster, Inc.
Drug-refractory Paroxysmal Atrial Fibrillation
Benefit of Left Atrial Roof Ablation in Paroxysmal Atrial Fibrillation
The aim of the present study is to assess whether left atrial roof ablation adds any benefit in the arrhythmia-free probability after paroxysmal atrial fibrillation ablation.
- Trial name
- NCT01203241
- Testing
- Pulmonary vein encircling, Pulmonary vein encircling plus roof ablation
- Where
- Spain
- Volunteers
- 120 people
- Sponsor
- Hospital Clinic of Barcelona
Paroxysmal Atrial Fibrillation
POLARx Post Approval Study (POLARx PAS)
To collect clinical data on safety, effectiveness and procedural success of Boston Scientific's Cardiac Cryoablation System (includes all BSC commercially available POLARx/POLARx Fit catheters) when used to perform pulmonary vein…
- Trial name
- NCT06170606
- Testing
- Boston Scientific Cardiac Cryoablation System
- Where
- 11 sites in United States
- Volunteers
- 200 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal Atrial Fibrillation
Boston Scientific's Single Shot LUMINIZE RF Balloon Catheter in the Treatment of Symptomatic, Drug Refractory Paroxysmal Atrial Fibrillation
To establish the safety and effectiveness of the LUMINIZE RF Balloon Catheter System for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial fibrillation (PAF).
- Trial name
- VISUALISE AF (NCT03852420)
- Testing
- LUMINIZE RF Balloon Catheter
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, Paroxysmal Arrhythmia
NAVISTAR® THERMOCOOL® SF Catheter: Observational Study
This is a prospective, interventional, observational, unblinded, single-arm, multicenter registry of younger and older subjects with drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation.
- Trial name
- SFAF (NCT01585961)
- Testing
- Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter)
- Where
- 45 sites in United States
- Volunteers
- 511 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation
TactiFlex Paroxysmal Atrial Fibrillation IDE Trial
Prospective non-randomized parallel-assignment multi-center clinical investigation. The study design includes two subject cohorts: 1) Paroxysmal Atrial Fibrillation Main Study, and 2) Paroxysmal Atrial Fibrillation High Standard…
- Trial name
- NCT04356040
- Testing
- TactiFlex SE, TactiFlex SE - High Standard Power
- Where
- 45 sites in United States, Australia and 8 more
- Volunteers
- 355 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
SMART-SF Radiofrequency Ablation Safety Study
This is a prospective safety assessment of the study device during radiofrequency (RF) ablation treatment of patients with drug refractory symptomatic atrial fibrillation (SMART-SF).
- Trial name
- NCT02359890
- Testing
- THERMOCOOL® SMARTTOUCH® (RF ablation treatment)
- Volunteers
- 165 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation
TactiSense IDE Trial of TactiCath SE for Paroxysmal Atrial Fibrillation
This clinical investigation is intended to demonstrate the acute safety and effectiveness of ablation with the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for the treatment of drug refractory…
- Trial name
- TactiSense (NCT03354663)
- Testing
- TactiCath SE
- Where
- 21 sites in United States, Australia and 2 more
- Volunteers
- 156 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic PAFOUS
The purpose of this study is to demonstrate safety and effectiveness of the Biosense Webster (BWI) ablation system (THERMOCOOL SMARTTOUCH surround flow [STSF] catheter and TRUPULSE generator) when used for isolation of the atrial…
- Trial name
- PulseSmart (NCT06272981)
- Testing
- Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation
- Where
- 7 sites in Australia, Canada
- Volunteers
- 136 people
- Sponsor
- Biosense Webster, Inc.
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
Atrial Fibrillation
PVAC GOLD Versus Irrigated RF Single Tip Catheter With Contact FORCE Ablation of the Pulmonary Veins for Treatment of Drug Refractory Symptomatic Paroxysmal and Persistent Atrial Fibrillation
The GOLD FORCE trial investigates the differences between treatment with a Contact Force single-tip catheter against the PVAC GOLD multielectrode catheter in cardiac ablation procedures in patients with paroxysmal atrial…
- Trial name
- GOLD-FORCE (NCT02463851)
- Testing
- PVAC GOLD multielectrode catheter, Contact Force single-tip ablation catheter
- Where
- 3 sites in Germany, Netherlands
- Volunteers
- 212 people
- Sponsor
- L.V.A. Boersma
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.
Atrial Fibrillation (AF), Paroxysmal AF
PulseMagic™ TrueForce™ PAF NMPA Study
This clinical investigation is intended to demonstrate safety and effectiveness of the PulseMagic™ TrueForce™ Ablation Catheter and the PulseMagic™Pulse Field Ablation (PFA) Generator, and Columbus™ 3D EP Navigation System with…
- Conditions
- Atrial Fibrillation (AF), Paroxysmal AF, Drug Refractory Paroxysmal Atrial Fibrillation, Atrial Arrhythmia
- Trial name
- PFATrueForce (NCT07720557)
- Testing
- PFA Ablation catheter
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.
Paroxysmal Atrial Fibrillation
Primary Anatomical Versus Primary Electrophysiological Approach in Circumferential Pulmonary Vein Ablation
Randomized comparison between 2 techniques of circumferential pulmonary vein ablation in paroxysmal atrial fibrillation: Primary anatomical ablation with secondary closure of possible electrical gaps versus primary…
- Trial name
- CPVA-PAF (NCT00556595)
- Testing
- primary electrophysiological approach, primary anatomical approach
- Volunteers
- 200 people
- Sponsor
- University Hospital, Bonn