Clinical trials: Paroxysmal Arrhythmia
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.
Atrial Fibrillation
Adenosine to Assess Complete Conduction Block During Catheter Ablation of Paroxysmal Atrial Fibrillation
The purpose of this study is to determine if additional ablation during the first procedure as the result of the ability to medically induce quiet atrial arrhythmias will improve clinical outcome in patients with atrial…
- Trial name
- NCT03032965
- Testing
- Adenosine, Isoproterenol
- Where
- United States
- Volunteers
- 131 people
- Sponsor
- University of Michigan
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
A Single Arm Pilot Study of Pulsed Field Ablation in the Treatment of Paroxysmal Atrial Fibrillation
The objective of this pilot study is to confirm that endocardial ablation using the FARAPULSE Ablation System Plus with commercial design devices is both safe and effective for treating drug-resistant paroxysmal atrial…
- Trial name
- FARA-Free (NCT04474054)
- Testing
- Catheter ablation to treat paroxysmal atrial fibrillation
- Where
- Croatia
- Volunteers
- 15 people
- Sponsor
- Boston Scientific Corporation
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
Paroxysmal Atrial Fibrillation
Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation.
The QDOT-FAST study is a prospective, multi-center, non-randomized, interventional clinical study.
- Trial name
- QDOT-FAST (NCT03459196)
- Testing
- THERMOCOOL SMARTTOUCH SF-5D Catheter
- Where
- 7 sites in Austria, Belgium and 2 more
- Volunteers
- 54 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
A Dose-range Finding Study of MAA868 in Patients With Atrial Fibrillation
This study is a multicenter, randomized, subject and Investigator-blinded, placebo-controlled, parallel-group, multiple ascending dose-ranging study to evaluate the safety, tolerability, pharmacokinetics (PK), and…
- Trial name
- NCT04213807
- Testing
- MAA868 Cohort 1, MAA868 Cohort 2, MAA868 Cohort 3
- Where
- 6 sites in United States
- Volunteers
- 28 people
- Sponsor
- Anthos Therapeutics, Inc.
Paroxysmal Atrial Fibrillation
TactiCath® Contact Force Ablation Catheter Study for Atrial Fibrillation Post Approval Study
A prospective, multicenter, interventional study to collect confirmatory evidence on the safety and effectiveness of the TactiCath® percutaneous ablation catheter in the post approval setting for the treatment of symptomatic…
- Trial name
- TactiCathPAS (NCT02310100)
- Testing
- TactiCath Quartz treatment
- Where
- 20 sites in United States
- Volunteers
- 178 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Atrial Fibrillation
A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation
This study (STOP AF) is a prospective, randomized, controlled, multicenter, pivotal clinical investigation conducted at 26 investigational sites in the United States and Canada.
- Trial name
- Stop-AF (NCT00523978)
- Testing
- Arctic Front® Cryoablation Catheter, Flecainide or Sotalol or Propafenone
- Where
- 26 sites in United States, Canada
- Volunteers
- 245 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Atrial Fibrillation
SMART China, A Multi-center Clinical Registry Study
This is a prospective effectiveness and safety assessment of the study device during radiofrequency (RF) ablation treatment of patients with drug refractory symptomatic atrial fibrillation.
- Trial name
- NCT02485925
- Testing
- THERMOCOOL® SMARTTOUCH™
- Volunteers
- 200 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation
PEFCATII Expanded Safety and Feasibility Study of the FARAPULSE Endocardial Multi Ablation System to Treat Paroxysmal Atrial Fibrillation
PEFCAT II: Expanded Safety and Feasibility Study of the FARAPULSE Endocardial Multi Ablation System to Treat Paroxysmal Atrial Fibrillation
- Trial name
- PEFCATII (NCT04170608)
- Testing
- FARAPULSE Endocardial Multi Ablation System
- Where
- 2 sites in Croatia, Czechia
- Volunteers
- 10 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal Atrial Fibrillation
Irrigated Ablation System Evaluation for Atrial Fibrillation (AF)
The purpose of this study is to test the safety and effectiveness of an Irrigated Ablation System for the treatment of symptomatic paroxysmal atrial fibrillation.
- Trial name
- IRASE-AF (NCT01056328)
- Testing
- SJM Irrigated Cardiac Ablation System, FDA approved Open Irrigated RF Ablation System
- Where
- 30 sites in United States, Canada and 1 more
- Volunteers
- 324 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Atrial Flutter
Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism
The purpose of this study is to evaluate major adverse bleeding risks, and thromboembolic event rates post radiofrequency (RF) ablation.
- Trial name
- NCT01976507
- Testing
- dabigatran etexilate mesylate
- Where
- United States
- Volunteers
- 101 people
- Sponsor
- Vanderbilt University Medical Center
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
Paroxysmal Atrial Fibrillation
Use of the Hansen Medical System in Patients With Paroxysmal Atrial Fibrillation
The purpose of this study is to assess the safety and performance of the Hansen Medical Sensei Robotic System and Artisan Catheter when used to robotically manipulate RF ablation catheters for the treatment of paroxysmal atrial…
- Trial name
- NCT01122173
- Testing
- Ablation
- Where
- 13 sites in United States, Czechia and 3 more
- Volunteers
- 150 people
- Sponsor
- Hansen Medical
Paroxysmal Supraventricular Tachycardia
Efficacy and Safety of Etripamil for the Termination of Spontaneous Paroxysmal Supraventricular Tachycardia (PSVT).
This was a three-part, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of etripamil nasal spray (NS) self-administered by participants who experienced an episode of paroxysmal…
- Trial name
- NODE-301 (NCT03464019)
- Testing
- Etripamil, Etripamil Test Dose
- Where
- 161 sites in United States, Belgium and 7 more
- Volunteers
- 1,097 people
- Sponsor
- Milestone Pharmaceuticals Inc.
Atrial Fibrillation Paroxysmal
Individualized Studies of Triggers of Paroxysmal Atrial Fibrillation
The I-STOP-Afib study will test the comparative effectiveness of using N-of-1 trials vs. symptom surveillance alone to reduce Atrial Fibrillation (AF) episode frequency and severity and improve quality of life for AF patients.
- Trial name
- I-STOP-AFib (NCT03323099)
- Testing
- N-of-1, Data Tracking
- Where
- United States
- Volunteers
- 499 people
- Sponsor
- University of California, San Francisco
Atrial Fibrillation
Effect of Structural Remodeling on Scar Formation as Assessed by DE-MRI of the Left Atrium
The purpose of this study is to evaluate the impact of pre-ablation fibrosis on scar formation in the left atrium of the heart. This will be assessed by delayed enhancement magnetic resonance imaging and will be looked at in…
- Trial name
- RADAR (NCT01187914)
- Volunteers
- 40 people
- Sponsor
- University of Utah
Atrial Fibrillation
A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE)
The primary objective is to demonstrate safety and long-term effectiveness of the irreversible electroporation (IRE) system (Circular IRE Catheter and IRE Generator) when used for isolation of the atrial pulmonary veins (PVs) in…
- Trial name
- inspIRE (NCT04524364)
- Testing
- Pulsed Field Ablation (PFA) Therapy
- Where
- 13 sites in Austria, Belgium and 6 more
- Volunteers
- 272 people
- Sponsor
- Biosense Webster, Inc.