Clinical trials: Paroxysmal Arrhythmia
Atrial Fibrillation, Atrial Fibrillation New Onset
STOP AF First: Cryoballoon Catheter Ablation in an Antiarrhythmic Drug Naive Paroxysmal Atrial Fibrillation
To provide data demonstrating the safety and effectiveness of the Arctic Front Advance™ Cardiac CryoAblation Catheter for the treatment of recurrent symptomatic paroxysmal atrial fibrillation, without the requirement that the…
- Trial name
- STOP AF First (NCT03118518)
- Testing
- Cryoablation, Antiarrhythmic drug
- Where
- 24 sites in United States
- Volunteers
- 225 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
High-Density (HD) Wave Mapping in Subjects With Atrial Fibrillation as a Predictor of Recurrence After a Single Ablation Procedure Using a PVI-Only Strategy
The aim is to use the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ to characterize the atrial substrate and develop a model for predicting recurrence rates after a single procedure using a PVI only approach and a contact…
- Conditions
- Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Cardiac Arrhythmia
- Trial name
- WAVE-MAP AF (NCT03882021)
- Testing
- A specific electrophysiology mapping protocol is applicable with the GRID catheter.
- Where
- 15 sites in Austria, Czechia and 7 more
- Volunteers
- 300 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
A Study of the Effectiveness of Anti-Arrhythmic Medications After Atrial Fibrillation Ablation
The purpose of this study is to examine the overall effectiveness of anti-arrhythmic medicines (to control heart rhythm) prescribed after an ablation procedure for atrial fibrillation.
- Trial name
- NCT00408200
- Testing
- propafenone; flecainide; sotalol; dofetilide, Radiofrequency catheter ablation
- Where
- 2 sites in United States
- Volunteers
- 110 people
- Sponsor
- University of Pennsylvania
Paroxysmal Atrial Fibrillation
Oral Anticoagulation Therapy Pilot Study
The objective of this study is to determine the safety of discontinuing oral anticoagulation therapy in high risk patients who have had a successful cardiac ablation and remain AF recurrence free for 3 months post ablation.
- Trial name
- OAT (NCT01959425)
- Testing
- Off OAT Group (Test), On OAT Group (Control)
- Volunteers
- 80 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.
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
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
Paroxysmal Supraventricular Tachycardia
Safety Study of Etripamil Nasal Spray for Patients With Paroxysmal Supraventricular Tachycardia. NODE-303
NODE-303 was a multi-center, open label study to evaluate the safety of etripamil NS in participants with Paroxysmal Supraventricular Tachycardia (PSVT).
- Trial name
- NCT04072835
- Testing
- Etripamil NS
- Where
- 124 sites in United States, Argentina and 3 more
- Volunteers
- 1,116 people
- Sponsor
- Milestone Pharmaceuticals Inc.
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
Cryoballoon PVI With PWI Versus PVI Alone In Patients With PAF
Cryoballoon ablation has emerged as a safe and effective strategy for treatment of atrial fibrillation (AF) for which it has recently received a 'first-line' therapy indication by the FDA.
- Trial name
- NCT05296824
- Testing
- Cryoballoon ablation for the treatment of atrial fibrillation
- Where
- 4 sites in United States
- Volunteers
- 320 people, healthy volunteers welcome
- Sponsor
- Sacramento EP Research
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 Supraventricular Tachycardia
Safety Study of Intranasal Etripamil for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia (PSVT). NODE-302
The primary objective of this study is to evaluate the safety of etripamil nasal spray (NS) 70 mg when self-administered by patients with an episode of Paroxysmal Supraventricular Tachycardia in an outpatient setting (i.e.…
- Trial name
- NCT03635996
- Testing
- Etripamil NS 70 mg, Aptar Pharma Nasal Spray Bidose System
- Where
- 34 sites in United States, Canada
- Volunteers
- 169 people
- Sponsor
- Milestone Pharmaceuticals Inc.
Paroxysmal Atrial Fibrillation
Post-Market Randomized Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation
To compare the safety and chronic Pulmonary Vein isolation of 2 ablation types. 1. visually guided ablation (VGA) using the EAS-AC and 2. radiofrequency ablation
- Trial name
- En-GARDE (NCT01057394)
- Testing
- Endoscopically guided PVI Ablation, RF PVI Ablation
- Where
- 2 sites in Czechia, Italy
- Volunteers
- 21 people
- Sponsor
- CardioFocus
Atrial Fibrillation
Selective Complex Fractionated Atrial Electrograms (CFAE) Targeting for Atrial Fibrillation
This study will be a multicenter, open, prospective, randomized trial. Patients with either paroxysmal or persistent atrial fibrillation will be considered for the study.
- Trial name
- SELECT-AF (NCT00926783)
- Testing
- CFAE ablation
- Where
- 7 sites in United States, Australia and 1 more
- Volunteers
- 86 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation
The FARAPULSE ADVENT PIVOTAL Trial PFA System vs SOC Ablation for Paroxysmal Atrial Fibrillation
This is a prospective, adaptive, multi-center, randomized safety and effectiveness pivotal study comparing the FARAPULSE Pulsed Field Ablation System with standard of care ablation with force-sensing RF catheters and cryoballoon…
- Trial name
- ADVENT (NCT04612244)
- Testing
- FARAPULSE Pulsed Field Ablation System, RadioFrequency and Cryoballoon Ablation
- Where
- 34 sites in United States
- Volunteers
- 706 people
- Sponsor
- Boston Scientific Corporation
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
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
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.
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, Persistent Atrial Fibrillation
HD Mapping of Atrial Fibrillation in Asia Pacific
The aim of this study is to quantify and characterize the outcomes of radiofrequency (RF) ablation after, and the utility of, electroanatomical mapping with the market-released HD mapping catheters Inquiry™ AFocusII™ Double Loop…
- Trial name
- NCT04022954
- Testing
- Catheter ablation
- Where
- 15 sites in China, Hong Kong and 3 more
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices