Catheter Ablation of Drug-refractory Persistent Atrial Fibrillation With the HeartLight(TM) Laser Balloon in Comparison With Irrigated Radiofrequency Current Ablation

Not Applicable

Completed

• Conditions: Persistent Atrial Fibrillation
• Interventions: Device: HeartLight(TM) Laser Balloon; Device: irrigated radiofrequency current ablation

• Registration Number: NCT01863472
• Lead Sponsor: Boris Schmidt

Brief Summary

Aim of the study is to compare the safety and efficacy of pulmonary vein isolation using the endoscopic ablation system in comparison to irrigated radiofrequency current ablation in patients with drug-refractory persistent atrial fibrillation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-19
• Study First Submitted QC: 2013-05-23
• Study First Posted: 2013-05-29
• Study Start: 2013-06
• Primary Completion: 2016-09
• Status Verified: 2016-11
• Study Completion: 2016-11
• Last Update Submitted: 2016-11-18
• Last Update Posted: 2016-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

• 18 to 80 years
• persistent atrial fibrillation
• failure of at least one antiarrhythmic drug
• others

Exclusion Criteria

• contraindications for pulmonary vein isolation (PVI)
• previous PVI attempts
• inability to be treated with oral anticoagulation
• presence of intracardiac thrombi
• pregnancy
• others

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HeartLight(TM) Laser Balloon	HeartLight(TM) Laser Balloon	Safety and efficacy of pulmonary vein isolation using the HeartLight(TM) Laser Balloon (endoscopically guided ablation)
irrigated radiofrequency current ablation	irrigated radiofrequency current ablation	Safety and efficacy of pulmonary vein isolation using the irrigated radiofrequency current ablation

Primary Outcome Measures

Name	Time	Method
Documented recurrence of atrial fibrillation or any atrial tachyarrhythmia >30 seconds	between day 90 and 365 days after index procedure

Trial Locations

Locations (6)

Na Homolce Hospital; 🇨🇿 Prague, Czech Republic

Herz- und Gefäß-Klinik GmbH Bad Neustadt; 🇩🇪 Bad Neustadt, Bavaria, Germany

Rheinische Friedrich-Wilhelms-Universität Bonn; 🇩🇪 Bonn, NRW, Germany

Cardioangiologisches Centrum Bethanien; 🇩🇪 Frankfurt/Main, Germany

Städtisches Klinikum Karlsruhe, Medizinische Klinik IV; 🇩🇪 Karlsruhe, Germany

Hospital Universitari i Politecnic La Fe; 🇪🇸 Valencia, Spain