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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02655731

Acronym

HEURECA

Enrollment

100

Registered

2016-01-14

Start date

2015-12-31

Completion date

2018-03-20

Last updated

2019-08-13

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

Conditions

Atrial Fibrillation

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).

Interventions

DEVICEPVI with HeartLight

Catheter ablation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026