This trial is active, not recruiting.

Condition persistent atrial fibrillation
Treatments heartlight(tm) laser balloon, irrigated radiofrequency current ablation
Sponsor Boris Schmidt
Start date June 2013
End date September 2016
Trial size 150 participants
Trial identifier NCT01863472, FF20/13 Version 03


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Safety and efficacy of pulmonary vein isolation using the HeartLight(TM) Laser Balloon (endoscopically guided ablation)
heartlight(tm) laser balloon
With the HeartLight(TM) Laser Balloon pulmonary vein isolation is done endoscopically guided
(Active Comparator)
Safety and efficacy of pulmonary vein isolation using the irrigated radiofrequency current ablation
irrigated radiofrequency current ablation
The irrigated radiofrequency current ablation is used for pulmonary vein isolation

Primary Outcomes

Documented recurrence of atrial fibrillation or any atrial tachyarrhythmia >30 seconds
time frame: between day 90 and 365 days after index procedure

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Catheter Ablation of Drug-refractory Persistent Atrial Fibrillation With the HeartLight(TM) Laser Balloon in Comparison With Irrigated Radiofrequency Current Ablation
Principal investigator Boris Schmidt, Dr.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Cardioangiologisches Centrum Bethanien.