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Completed

NCT Number: NCT02655731

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

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).

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardioangiologisches Centrum Bethanien

Frankfurt am Main, 60431, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PVI with HeartLight

Device

Catheter ablation

Primary outcomes

  1. Freedom from atrial fibrillation and atrial tachyarrhythmias

    Time frame: 12 months

    72h Holter-ECG recordings will be performed. In case of clinical arrhythmia symptoms event-recording will be provided.

Sponsors and collaborators

Lead sponsor

Cardioangiologisches Centrum Bethanien

Other

Registry information

Acronym: HEURECA

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jan 14, 2016
Registry last updated
Aug 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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