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

Boris Schmidt

Status: Completed

Conditions: Persistent Atrial Fibrillation

Treatments: Device: irrigated radiofrequency current ablation; Device: HeartLight(TM) Laser Balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT01863472

FF20/13 Version 03

Details and patient eligibility

About

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.

Enrollment: 152 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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152 participants in 2 patient groups

HeartLight(TM) Laser Balloon

Active Comparator group

Description:

Safety and efficacy of pulmonary vein isolation using the HeartLight(TM) Laser Balloon (endoscopically guided ablation)

Treatment:

Device: HeartLight(TM) Laser Balloon

irrigated radiofrequency current ablation

Active Comparator group

Description:

Safety and efficacy of pulmonary vein isolation using the irrigated radiofrequency current ablation

Treatment:

Device: irrigated radiofrequency current ablation