Clinical trials: Atrial Fibrillation Paroxysmal
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.
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
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
Paroxysmal Atrial Fibrillation
IMPULSE: A Safety and Feasibility Study of the IOWA Approach Endocardial Ablation System to Treat Atrial Fibrillation
IMPULSE is a prospective, single-arm, multi-center, safety and feasibility study evaluating the IOWA Approach Endocardial Ablation System (FARAPULSE, Inc.) for the treatment of paroxysmal atrial fibrillation.
- Trial name
- NCT03700385
- Testing
- IOWA Approach Endocardial Ablation System
- Where
- 2 sites in Czechia, France
- Volunteers
- 40 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
Atrial Fibrillation
Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System
To demonstrate the safety and 12-month effectiveness of the VARIPULSE™ Catheter when used in conjunction with the TRUPULSE™ Generator for pulmonary vein isolation (PVI) in the treatment of subjects with symptomatic paroxysmal…
- Trial name
- AdmIRE (NCT05293639)
- Testing
- Pulse Field Ablation
- Where
- 30 sites in United States
- Volunteers
- 362 people
- Sponsor
- Biosense Webster, Inc.
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.
Paroxysmal Atrial Fibrillation
Prospective Evaluation of Open Irrigated Ablation Catheters With High Resolution Mapping to Treat Paroxysmal Atrial Fibrillation
To obtain data for the Rhythmia™ Mapping System in conjunction with Boston Scientific Open-Irrigated (OI) Catheters for ablation of Paroxysmal Atrial Fibrillation (PAF) according to current international and local guidelines.
- Trial name
- INTERRUPT AF (NCT03729830)
- Testing
- Boston Scientific Open Irrigated Ablation Catheters
- Where
- 26 sites in United States, Germany and 4 more
- Volunteers
- 415 people
- Sponsor
- Boston Scientific Corporation
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.
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
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.
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
Continued Access Protocol
This Continued Access Protocol has been written to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the Arctic Front® Cryoablation System is under review.
- Trial name
- CAP-AF (NCT00889681)
- Testing
- Arctic Front Cardiac Cryoablation System
- Where
- 10 sites in United States
- Volunteers
- 81 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
A Study Assessing Arrhythmia Mapping With a Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter
The purpose of this study is to assess the performance and safety for the use of the investigational catheter for intracardiac mapping in the atria and ventricles.
- Conditions
- Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Ventricular Tachycardia
- Trial name
- COSMOS (NCT05373862)
- Testing
- Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter
- Where
- 4 sites in Belgium, Croatia and 1 more
- Volunteers
- 40 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation, Atrial Fibrillation
DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation
The purpose of the DIAMOND-AF study is to establish the safety and effectiveness of the DiamondTemp System for the treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation in patients.
- Trial name
- DIAMOND-AF (NCT03334630)
- Testing
- DiamondTemp Ablation catheter, TactiCath Quartz Ablation catheter
- Where
- 23 sites in United States, Canada and 3 more
- Volunteers
- 482 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Paroxysmal Atrial Fibrillation
Clinical Evaluation of the StablePoint Catheter and Force Sensing System for Paroxysmal Atrial Fibrillation
The NEwTON AF study is a multi-center, global, prospective, single arm study to establish the safety and effectiveness of the IntellaNav StablePoint Catheter and Force-Sensing System in subjects with symptomatic, drug refractory…
- Trial name
- NEwTON AF (NCT04580914)
- Testing
- Treatment with IntellaNav StablePoint Ablation Catheter
- Where
- 47 sites in United States, Austria and 11 more
- Volunteers
- 321 people
- 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.
Arrhythmia
Qubic Stim Cardiac Stimulator in China
106 subjects selected from 3 study sites in China are with indications for intracardiac electrophysiological examination. The trial is to prove the clinical effectiveness and safety of Qubic Stim Cardiac Stimulator in Chinese…
- Trial name
- NCT04390841
- Testing
- Cardiac Stimulator
- Where
- 3 sites in China
- Volunteers
- 106 people
- Sponsor
- Biotronik (Beijing) Medical Device Ltd.
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