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

Cardioangiologisches Centrum Bethanien

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Device: PVI with HeartLight

Study type: Interventional

Funder types: Other

Identifiers

NCT02655731

FF117/2015

Details and patient eligibility

About

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).

Full 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).

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Treatment

Other group

Description:

PVI with HeartLight

Treatment:

Device: PVI with HeartLight