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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01863472

Enrollment

152

Registered

2013-05-29

Start date

2013-06-30

Completion date

2016-11-30

Last updated

2016-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistent Atrial Fibrillation

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.

Interventions

DEVICEHeartLight(TM) Laser Balloon

With the HeartLight(TM) Laser Balloon pulmonary vein isolation is done endoscopically guided

DEVICEirrigated radiofrequency current ablation

The irrigated radiofrequency current ablation is used for pulmonary vein isolation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

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

Countries

Czechia, Germany, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026