NCT02655731

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Cardioangiologisches Centrum Bethanien · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	PVI with HeartLight	Catheter ablation

Timeline

• Start date: 2015-12-01
• Primary completion: 2018-03-20
• Completion: 2018-03-20
• First posted: 2016-01-14
• Last updated: 2019-08-13

Locations

1 site across 1 country: Germany