Clinical trials: Symptomatic Paroxysmal Atrial Fibrillation (PAF)
Paroxysmal Atrial Fibrillation
NAVISTAR® THERMOCOOL® Catheter Post Approval Registry
The purpose of this registry is to provide additional corroborative short-term safety and long-term safety data for the NAVISTAR THERMOCOOL and NAVISTAR EZ STEER THERMOCOOL catheters in the treatment of symptomatic Paroxysmal…
- Trial name
- AF Registry (NCT00964392)
- Testing
- Atrial fibrillation ablation
- Volunteers
- 437 people
- Sponsor
- Biosense Webster, Inc.
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.
Bradycardia, Atrial Fibrillation
Atrial Pacing for Termination and Prevention of Atrial Fibrillation
Atrial fibrillation (AF) is the most common sustained arrhythmia and is associated with substantial morbidity and mortality. Present treatment strategies are aimed at termination of AF and prevention of AF recurrence using…
- Trial name
- NCT00123344
- Testing
- AT501 pacemaker
- Where
- Canada
- Volunteers
- 120 people
- Sponsor
- University of Calgary
Atrial Fibrillation
Clinical Study for Workflow and Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System for Treating Symptomatic Paroxysmal AF (QDOT-Micro)
The QDOT-Micro study is a prospective, multi-center, non-randomized, interventional clinical study.
- Trial name
- NCT02944968
- Testing
- THERMOCOOL SMARTTOUCH® SF-5D catheter
- Volunteers
- 51 people
- Sponsor
- Biosense Webster, Inc.
Symptomatic Paroxysmal Atrial Fibrillation (PAF)
FIRE AND ICE: Comparative Study of Two Ablation Procedures in Patients With Atrial Fibrillation
Comparing efficacy and safety of isolation of the pulmonary veins (PV) using a Cryoballoon catheter versus a radiofrequency ablation with a ThermoCool catheter in patients with paroxysmal atrial fibrillation.
- Trial name
- NCT01490814
- Testing
- Electrical isolation of the pulmonary veins, Electrical isolation of pulmonary veins
- Where
- 19 sites in Czechia, France and 6 more
- Volunteers
- 769 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
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
Flecainide Acetate Inhalation Solution for Cardioversion of Recent-Onset, Symptomatic Atrial Fibrillation
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical study designed to evaluate the efficacy and safety of FlecIH-103 (flecainide acetate inhalation solution) compared with placebo in patients…
- Trial name
- RESTORE-1 (NCT05039359)
- Testing
- FlecIH-103
- Where
- 40 sites in United States, Czechia and 4 more
- Volunteers
- 54 people
- Sponsor
- InCarda Therapeutics, 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.
Atrial Fibrillation
Pivotal Clinical Study of Endoscopic Ablation for Atrial Fibrillation (AF) in Patients That Have Failed Drugs
The purpose of the study is to compare two types of treatment for atrial fibrillation (AF) that are designed to treat the symptoms of atrial fibrillation.
- Trial name
- ENABLE (NCT00477230)
- Testing
- Endoscopic Ablation System, Standard Anti-arrhythmic Drug (AAD) Therapy
- Where
- 18 sites in United States
- Volunteers
- 64 people
- Sponsor
- CardioFocus
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.
Atrial Fibrillation
Precision Ablation For Pulmonary Vein Isolation: Targeting Pulmonary Vein Myocardial Sleeves (PVMS) With Omnipolar Mapping Technology
The purpose of this study is to compare procedural times and Radiofrequency (RF)applications required for Pulmonary vein myocardial sleeves targeted pulmonary vein ablation (PVS-PVI) , to compare the efficacy of PVS-PVI , to…
- Trial name
- PVS-PVI (NCT06701292)
- Testing
- PVS-PVI targeted ablation, Wide area circumferential ablation (WACA)
- Where
- United States
- Sponsor
- The University of Texas Health Science Center, Houston
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
Fibrillation, Atrial
Evaluation of Efficacy and Safety of Lovaza (Omega-3-Acid Ethyl Esters) in Recurrent, Symptomatic Atrial Fibrillation
The purpose of this study is to evaluate efficacy and safety of Omacor (omega-3-acid ethyl esters) in patients with recurrent, symptomatic atrial fibrillation.
- Trial name
- NCT00402363
- Testing
- omega-3-acid ethyl esters
- Where
- 178 sites in United States
- Volunteers
- 663 people
- Sponsor
- GlaxoSmithKline
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.
Symptomatic Paroxysmal Atrial Fibrillation Without Clinically Significant Heart Diseases
Catheter Cryoablation Versus Antiarrhythmic Drug as First-Line Therapy of Paroxysmal Atrial Fibrillation
The purpose of this study is to evaluate the effectiveness of Pulmonary Vein Isolation (PVI) performed with the Arctic Front™ Advance Cardiac CryoAblation Catheter System as first-line therapy in comparison with antiarrhythmic…
- Trial name
- NCT01803438
- Testing
- cryoballoon ablation system, Antiarrhythmic Drugs
- Where
- 19 sites in Argentina, Australia and 7 more
- Volunteers
- 220 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Heart Diseases, Arrhythmia
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
The purpose of this study is to demonstrate the safety and effectiveness of the THERMOCOOL® SMARTTOUCH™ Catheters with Contact Force Sensing Capability in the treatment of drug refractory symptomatic paroxysmal Atrial…
- Conditions
- Heart Diseases, Arrhythmia, Atrial Fibrillation
- Trial name
- NCT01385202
- Testing
- THERMOCOOL® SMARTTOUCH™ Catheter
- Volunteers
- 172 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation (PAF)
INhalation of Flecainide to Convert Recent Onset SympTomatic Atrial Fibrillation to siNus rhyThm (INSTANT)
The study consisted of 3 parts (Part A, Part B and Part C). Part A was an open-label, randomized, multi center design to evaluate the feasibility of administration of inhaled flecainide in two dosing regimens.
- Trial name
- INSTANT (NCT03539302)
- Testing
- Flecainide Acetate
- Where
- 9 sites in Belgium, Netherlands
- Volunteers
- 176 people
- Sponsor
- InCarda Therapeutics, Inc.
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 (PAF), Persistent Atrial Fibrillation
Outcomes of an Optimized Workflow With PulseSelect Pulsed Field Ablation (PFA) System in Paroxysmal and Persistent Atrial Fibrillation
The NEXT PULSE study is a pre-market, prospective, multi-center, non-randomized, interventional clinical study. Adult subjects with symptomatic paroxysmal or persistent AF who provided consent will be enrolled and treated with…
- Trial name
- NEXT PULSE (NCT07575828)
- Testing
- PulseSelect Pulse Field Ablation (PFA) System
- Volunteers
- 320 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
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