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

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.

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Key information

Conditions

Persistent Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Na Homolce Hospital, Prague, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HeartLight(TM) Laser Balloon

Device

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

irrigated radiofrequency current ablation

Device

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

Sponsors and collaborators

Lead sponsor

Boris Schmidt

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: May 29, 2013
Registry last updated: Nov 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed