Clinical trials: Paroxysmal Arrhythmia
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 Paroxysmal
Esophageal Temperature During PVI Using Q-DOT Micro
This study will assess how two different ablation strategies, using two different ablation catheters during catheter ablation for paroxysmal atrial fibrillation, affect the temperature of the esophagus during ablation, and the…
- Trial name
- NCT06392932
- Testing
- QDOT Micro ablation catheter, ST SF ablation catheter
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Cedars-Sinai Medical Center
Paroxysmal Atrial Fibrillation, Stress
SMART Program for Paroxysmal Atrial Fibrillation
This is a pilot study to test the effects of the SMART-3RP (Stress Management and Resiliency Training Relaxation Response Resiliency Program) on quality of life, mental health, arrhythmia burden, and heart rate variability (HRV)…
- Trial name
- NCT03450993
- Testing
- SMART Program
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Massachusetts General Hospital
Atrial Fibrillation
Comparison of RF and crYoballoon ablatiOn Therapy of AF（CRYO-AF）
It's a multi-center, prospective, randomized, controlled clinical trial of cryoballoon versus radiofrequency ablation for paroxysmal atrial fibrillation.
- Trial name
- CRYO-AF (NCT03044951)
- Testing
- cryoballoon ablation, radiofrequency ablation
- Where
- China
- Volunteers
- 600 people
- Sponsor
- Ruijin Hospital
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Pulmonary Vein Isolation Versus Botulinum Toxin Injection Plus Pulmonary Vein Isolation in Patients With Atrial Fibrillation
The investigators have conducted a prospective, double-blind, randomized study to assess the comparative safety and efficacy of two different treatment strategies, PVI only versus PVI plus BT injection, in patients with…
- Trial name
- NCT02002923
- Testing
- Pulmonary vein isolation, Botulinum Toxin
- Where
- Russia
- Volunteers
- 160 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Atrial Fibrillation Paroxysmal
Zero-fluoroscopic Cryoballoon Ablation
This study aimed to investigate safety and efficacy of intracardiac echocardiography (ICE)-guided zero-fluoroscopic cryoballoon ablation (CBA) in patients with paroxysmal atrial fibrillation.
- Trial name
- NCT05711589
- Testing
- CBA was performed under intracardiac echocardiography guidance without fluoroscopy, cryoablation (CBA) was performed under fluoroscopic guidance
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Pusan National University Hospital
Atrial Fibrillation
PVAC GOLD Versus Irrigated RF Single Tip Catheter With Contact FORCE Ablation of the Pulmonary Veins for Treatment of Drug Refractory Symptomatic Paroxysmal and Persistent Atrial Fibrillation
The GOLD FORCE trial investigates the differences between treatment with a Contact Force single-tip catheter against the PVAC GOLD multielectrode catheter in cardiac ablation procedures in patients with paroxysmal atrial…
- Trial name
- GOLD-FORCE (NCT02463851)
- Testing
- PVAC GOLD multielectrode catheter, Contact Force single-tip ablation catheter
- Where
- 3 sites in Germany, Netherlands
- Volunteers
- 212 people
- Sponsor
- L.V.A. Boersma
Atrial Fibrillation
Comparison of Expandable and Fixed Size Cryoballoon for the Treatment of Paroxysmal Atrial Fibrillation
The goal of this clinical trial is to compare two different, market approved, cryoballoon devices for the treatment of paroxysmal atrial fibrillation (AF).
- Trial name
- NCT06183879
- Testing
- cryoballoon pulmonary vein isolation (Medtronic 4th gen balloon), cryoballoon pulmonary vein isolation (Boston 2nd gen balloon)
- Where
- 2 sites in Croatia
- Volunteers
- 150 people
- Sponsor
- University of Zagreb
Atrial Fibrillation, Afib
Clinical Performance of the AFGen1 Device Over a 7-day Period
AFGen1 is indicated for use on symptomatic or asymptomatic adults who are at risk of developing or who have atrial fibrillation, where a software assisted analysis of ambulatory ECG is needed to identify episodes of Afib.
- Conditions
- Atrial Fibrillation, Afib, Irregular Heart Beat, Arrhythmias, Cardiac
- Trial name
- NCT05295056
- Testing
- AFGen1 Device Wear Test, AFGen 1 Device Single Use
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- TriVirum, Inc.
Atrial Fibrillation (AF), Paroxysmal AF
Dose Escalation Study to Assess Safety, Tolerability, and Efficacy of Budiodarone Treatment With Non-permanent Atrial Fibrillation
This multicenter, open-label study aims to assess the safety, tolerability and efficacy of budiodarone in treating participants with non-permanent AF, in particular paroxysmal atrial fibrillation (PAF).
- Trial name
- Harbor-AF (NCT07792239)
- Testing
- Budiodarone 200 mg BID, Budiodarone 400 mg BID, Budiodarone 600 mg BID
- Where
- 4 sites in Poland
- Volunteers
- 100 people
- Sponsor
- Xyra, LLC
Paroxysmal Supraventricular Tachycardia
The NODE-202 Study (Study of Etripamil Nasal Spray in Pediatric Patients)
NODE-202 is a Phase 2, multicenter, multinational, single dose, open-label, 2-part, sequential design study in pediatric patients with an established diagnosis of paroxysmal supraventricular tachycardia (PSVT) presenting with a…
- Trial name
- NCT05763953
- Testing
- Etripamil NS
- Where
- 10 sites in United States, Canada and 2 more
- Volunteers
- 60 people
- Sponsor
- Milestone Pharmaceuticals 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
Atrial Fibrillation
Electrophysiological Effects of NACOS and AVK on Pulmonary Veins and Left Atrium in Paroxysmal AF Catheter Ablation
Atrial fibrillation (AF) is the most common cardiac arrhythmias with a constantly growing prevalence AF. The purpose of paroxysmal AF processing is to control outbreaks from these pulmonary veins, medicated way (antiarrhythmic)…
- Trial name
- NACO-VP (NCT02814955)
- Where
- France
- Volunteers
- 90 people
- Sponsor
- University Hospital, Caen
Atrial Fibrillation, Atrial Fibrillation (Paroxysmal)
Wide-Antral Pulmonary Vein Isolation in Atrial Fibrillation Ablation with a Single-shot Technique (WIDER-PVI)
The WIDER PVI study is a multicentre randomized clinical trial to compare the efficacy of antral versus extended antral PVI in patients with paroxysmal or persistent AF undergoing this procedure using a cryoablation balloon…
- Trial name
- WIDER-PVI (NCT06698159)
- Testing
- Cryoablation with cryoballoon 28 mm, Cryoablation with cryoballoon 31 mm
- Where
- 17 sites in Italy, Spain
- Volunteers
- 440 people
- Sponsor
- Hospital Universitario 12 de Octubre
Paroxysmal AF, Atrial Arrhythmia
BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF
This study is designed to obtain real-world clinical evidence on the safety and effectiveness of the Volt PFA System in various use cases, with a sub study designed to address additional clinical evidence needs in…
- Conditions
- Paroxysmal AF, Atrial Arrhythmia, Atrial Fibrillation, Persistent Atrial Fibrillation
- Trial name
- BLAST-OFF (NCT07181590)
- Testing
- Pulsed Field Ablation
- Where
- 22 sites in Austria, Belgium and 10 more
- Volunteers
- 300 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Atrial Fibrillation
Pulmonary Vein Isolation Strategy of Very High Power Short Duration in Patients With Paroxysmal Atrial Fibrillation
This study aims to investigate the effect of reducing ablation time for a hybrid approach of vHPSD and AI-guided ablation using the QDOT Micro catheter in PVI among patients with PAF.
- Trial name
- NCT05996159
- Testing
- QDOT MicroTM catheter, AI-guided ablation only for PVI
- Where
- South Korea
- Volunteers
- 150 people
- Sponsor
- Seoul National University Hospital
Atrial Fibrillation, Paroxysmal
Clinical Efficacy of Potassium Canrenoate in Sinus Rhythm Restoration Among Patients With Atrial Fibrillation.
The purpose of this randomized, double blind, placebo-controlled, superiority clinical trial was to assess clinical efficacy of potassium canrenoate - canrenone in rapid conversion of atrial fibrillation to sinus rhythm.
- Trial name
- CANREN-AF (NCT03536806)
- Testing
- Saline 0.9%, Canrenone
- Volunteers
- 80 people
- Sponsor
- National Institute of Cardiology, Warsaw, Poland
Paroxysmal AF
FARAPULSE™ Pulsed Field Ablation System
To obtain real world data on the use of, and provide continued evidence on safety and effectiveness of the FARAPULSE™ Pulsed Field Ablation (PFA) system when used per hospitals' standard of care in Chinese population.
- Trial name
- NCT06762717
- Testing
- FARAPULSE™ Pulsed Field Ablation system
- Where
- China
- Volunteers
- 501 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
Atrial Fibrillation
CPVI Alone Versus. CPVI Plus Electrophysiological Substrate Ablation in the LA During SR for the Treatment of Non-PAF
The primary objective of this investigation is to compare the efficacy of two different AF ablation strategies in patients with non-paroxysmal AF: CPVI plus electrophysiologic substrate ablation in the left atrium during sinus…
- Trial name
- STABLE-SR_II (NCT03448562)
- Testing
- CPVI, STABLE-SR
- Where
- China
- Volunteers
- 300 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University