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

Atrial Fibrillation Clinical Trial

— HEURECA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02655731
• Other study ID #: FF117/2015
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: March 20, 2018

Study information

• Verified date: August 2019
• Source: Cardioangiologisches Centrum Bethanien
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 20, 2018
• Est. primary completion date: March 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• PVI with HeartLight
Catheter ablation

Locations

Country	Name	City	State
Germany	Cardioangiologisches Centrum Bethanien	Frankfurt/Main

Sponsors (1)

Lead Sponsor	Collaborator
Cardioangiologisches Centrum Bethanien

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from atrial fibrillation and atrial tachyarrhythmias	72h Holter-ECG recordings will be performed. In case of clinical arrhythmia symptoms event-recording will be provided.	12 months