HeartLight Guided - Pure Pulmonary Vein Isolation Regardless of Concomitant Atrial Substrate

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: PVI with HeartLight

• Registration Number: NCT02655731
• Lead Sponsor: Cardioangiologisches Centrum Bethanien

Brief Summary

Aim of the present prospective, single-centre study is to determine the outcome after pure PVI using HeartLight™ in 100 patients with different extents of LA-LVA.

The latter will be assessed by an electro-anatomical voltage map using a commercial 3D mapping system (CARTO, Biosense Webster).

Detailed Description

The ablation strategy for patients with atrial fibrillation (AF) and concomitant atrial substrate (e.g. low-voltage areas; LVA) is a matter of controversy.

Results of studies investigating the impact of LVA may have been confounded by PV-to-left-atrial (LA) reconnection due to non-durable ablation. Therefore, the true contribution of LA-LVA to AF recurrences remains unknown.

Meanwhile, new ablation technologies such as the HeartLight™ laser balloon (LB) ablation system providing near complete chronic PVI rates have been developed.

Aim of the present prospective, single-centre study is to determine the outcome after pure PVI using HeartLight™ in 100 patients with different extents of LA-LVA.

The latter will be assessed by an electro-anatomical voltage map using a commercial 3D mapping system (CARTO, Biosense Webster).

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-23
• Study First Submitted QC: 2016-01-13
• Study First Posted: 2016-01-14
• Primary Completion: 2018-03-20
• Study Completion: 2018-03-20
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-12
• Last Update Posted: 2019-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Symptomatic atrial fibrillation
• Left atrial size <50mm
• Left ventricular ejection fraction <45%
• Patient is able to provide informed consent

Exclusion Criteria

• Contraindications for PVI
• Previous PVI attempts
• Inability to be treated with oral anticoagulation
• Presence of intracardiac thrombi
• Pregnancy
• Participation in other clinical studies
• Unwilling to follow the study protocol and to attend follow-up visits

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	PVI with HeartLight	PVI with HeartLight

Primary Outcome Measures

Name	Time	Method
Freedom from atrial fibrillation and atrial tachyarrhythmias	12 months	72h Holter-ECG recordings will be performed. In case of clinical arrhythmia symptoms event-recording will be provided.

Trial Locations

Locations (1)

Cardioangiologisches Centrum Bethanien; 🇩🇪 Frankfurt/Main, Germany