Clinical trials: Atrial Fibrillation Paroxysmal
Paroxysmal Atrial Fibrillation
FIRM Ablation Versus Pulmonary Vein Isolation for the Treatment of Paroxysmal Atrial Fibrillation (PAF)
The study is designed as a prospective, multicenter, single-blind, randomized study to assess the safety and effectiveness of FIRM-guided radiofrequency (RF) ablation procedures for the treatment of symptomatic paroxysmal atrial…
- Trial name
- FIRMAP-AF (NCT02703454)
- Testing
- FIRM-guided RF ablation, Conventional RF ablation
- Where
- Germany
- Volunteers
- 51 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Atrial Fibrillation
Comparison of PolarX and the Arctic Front Cryoballoons for PVI in Patients With Symptomatic Paroxysmal AF
Pulmonary vein isolation (PVI) is an effective treatment for atrial fibrillation (AF). Single shot devices are increasingly used for PVI.
- Trial name
- COMPARE-CRYO (NCT04704986)
- Testing
- PVI using the Arctic Front Cryoballoon (Medtronic), PVI using the PolarX Cryoballoon (Boston Scientific)
- Where
- 2 sites in Switzerland
- Volunteers
- 202 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
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
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.
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.
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
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
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
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
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
A Trial to Determine the Safety, Pharmacokinetics, and Efficacy of OPC-108459 Administered as a Single Intravenous Dose to Patients With Paroxysmal or Persistent Atrial Fibrillation (AF)
To investigate the safety, pharmacokinetics, and efficacy following 30-minute continuous intravenous administration of OPC-108459 at 0.4, 0.8, 1.6, or 2.4 mg/kg or placebo to patients with paroxysmal or persistent atrial…
- Trial name
- NCT02069119
- Testing
- OPC-108459
- Where
- Japan
- Volunteers
- 48 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Heart Diseases, Arrhythmia
NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation
This trial compares the safety and effectiveness of catheter ablation for PAF with antiarrhythmic drug therapy. The investigational catheter being studied is the NAVISTAR® THERMOCOOL® irrigated-tip catheter.
- Conditions
- Heart Diseases, Arrhythmia, Atrial Fibrillation
- Trial name
- Afib IDE (NCT00116428)
- Testing
- NAVISTAR® THERMOCOOL® Catheter, Antiarrhythmic drug
- Where
- 17 sites in United States, Brazil and 3 more
- Volunteers
- 167 people
- Sponsor
- Biosense Webster, 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
IMPACT: A Safety and Feasibility Study of the IOWA Approach Cardiac Ablation System
IMPACT is a prospective, single-arm, multi-center, safety and feasibility study evaluating the IOWA Approach Cardiac Ablation System (FARAPULSE, Inc.) for the treatment of paroxysmal atrial fibrillation.
- Trial name
- IMPACT (NCT03700372)
- Testing
- IOWA Approach Cardiac Ablation System
- Where
- France
- Volunteers
- 7 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
A Study For Treatment of Paroxysmal Atrial Fibrillation (PAF) With the OMNYPULSE Catheter and the TRUPULSE Generator
The purpose of this study is to demonstrate safety and effectiveness of the ablation system (OMNYPULSE Bi-directional catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of…
- Trial name
- Omny-IRE (NCT05971693)
- Testing
- OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator
- Where
- 13 sites in Belgium, Canada and 6 more
- Volunteers
- 188 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation (PAF)
Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS)
The Post-Approval Study (PAS) is a prospective multi-center, non-randomized, single arm, controlled,unblinded clinical study designed to provide long-term safety and effectiveness of the Arctic Front® Cardiac CryoAblation System.
- Trial name
- STOP AF PAS (NCT01456949)
- Testing
- Medtronic Arctic Front® Cardiac CryoAblation System
- Where
- 39 sites in United States, Canada
- Volunteers
- 402 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Paroxysmal Atrial Fibrillation
TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation
The TOCCASTAR Study will assess the safety and effectiveness of a contact force sensing catheter used for ablation in patients with paroxysmal atrial fibrillation.
- Trial name
- TOCCASTAR (NCT01278953)
- Testing
- Catheter ablation to treat paroxysmal atrial fibrillation
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Atrial Fibrillation
Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein Isolation in Subjects With Paroxysmal Atrial Fibrillation
Prospective, non-randomized, pre-market clinical evaluation of the QDOT MICRO™ Catheter to demonstrate the safety and effectiveness when compared to an historical control performance goal.
- Trial name
- Q-FFICIENCY (NCT03775512)
- Testing
- RF Ablation with QDOT Micro
- Where
- 22 sites in United States
- Volunteers
- 283 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation, Paroxysmal Atrial Fibrillation
FIRE AND ICE Re-Ablations (Retrospective Data Collection)
Retrospective data collection on re-ablations performed within the FIRE AND ICE Trial.
- Trial name
- Re-Do (NCT03314753)
- Testing
- No interventions - retrospective data collection
- Where
- 13 sites in Czechia, France and 4 more
- Volunteers
- 89 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
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