HeartLight Guided - Pure Pulmonary Vein Isolation Regardless of Concomitant Atrial Substrate (HEURECA)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
PVI with HeartLight
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
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
Sites / Locations
- Cardioangiologisches Centrum Bethanien
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Treatment
Arm Description
PVI with HeartLight
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02655731
First Posted
December 23, 2015
Last Updated
August 12, 2019
Sponsor
Cardioangiologisches Centrum Bethanien
1. Study Identification
Unique Protocol Identification Number
NCT02655731
Brief Title
HeartLight Guided - Pure Pulmonary Vein Isolation Regardless of Concomitant Atrial Substrate
Acronym
HEURECA
Official Title
HeartLight Guided - Pure Pulmonary Vein Isolation Regardless of Concomitant Atrial Substrate
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
March 20, 2018 (Actual)
Study Completion Date
March 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardioangiologisches Centrum Bethanien
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Other
Arm Description
PVI with HeartLight
Intervention Type
Device
Intervention Name(s)
PVI with HeartLight
Intervention Description
Catheter ablation
Primary Outcome Measure Information:
Title
Freedom from atrial fibrillation and atrial tachyarrhythmias
Description
72h Holter-ECG recordings will be performed. In case of clinical arrhythmia symptoms event-recording will be provided.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boris Schmidt, MD
Organizational Affiliation
Cardioangiologisches Centrum Bethanien
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardioangiologisches Centrum Bethanien
City
Frankfurt/Main
ZIP/Postal Code
60431
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
HeartLight Guided - Pure Pulmonary Vein Isolation Regardless of Concomitant Atrial Substrate
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