Catheter Ablation of Drug-refractory Persistent Atrial Fibrillation With the HeartLight(TM) Laser Balloon in Comparison With Irrigated Radiofrequency Current Ablation
Primary Purpose
Persistent Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
HeartLight(TM) Laser Balloon
irrigated radiofrequency current ablation
Sponsored by
About this trial
This is an interventional treatment trial for Persistent Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- 18 to 80 years
- persistent atrial fibrillation
- failure of at least one antiarrhythmic drug
- others
Exclusion Criteria:
- contraindications for pulmonary vein isolation (PVI)
- previous PVI attempts
- inability to be treated with oral anticoagulation
- presence of intracardiac thrombi
- pregnancy
- others
Sites / Locations
- Na Homolce Hospital
- Herz- und Gefäß-Klinik GmbH Bad Neustadt
- Rheinische Friedrich-Wilhelms-Universität Bonn
- Cardioangiologisches Centrum Bethanien
- Städtisches Klinikum Karlsruhe, Medizinische Klinik IV
- Hospital Universitari i Politecnic La Fe
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
HeartLight(TM) Laser Balloon
irrigated radiofrequency current ablation
Arm Description
Safety and efficacy of pulmonary vein isolation using the HeartLight(TM) Laser Balloon (endoscopically guided ablation)
Safety and efficacy of pulmonary vein isolation using the irrigated radiofrequency current ablation
Outcomes
Primary Outcome Measures
Documented recurrence of atrial fibrillation or any atrial tachyarrhythmia >30 seconds
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01863472
Brief Title
Catheter Ablation of Drug-refractory Persistent Atrial Fibrillation With the HeartLight(TM) Laser Balloon in Comparison With Irrigated Radiofrequency Current Ablation
Official Title
Catheter Ablation of Drug-refractory Persistent Atrial Fibrillation With the HeartLight(TM) Laser Balloon in Comparison With Irrigated Radiofrequency Current Ablation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Boris Schmidt
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Aim of the study is to compare the safety and efficacy of pulmonary vein isolation using the endoscopic ablation system in comparison to irrigated radiofrequency current ablation in patients with drug-refractory persistent atrial fibrillation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
152 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HeartLight(TM) Laser Balloon
Arm Type
Active Comparator
Arm Description
Safety and efficacy of pulmonary vein isolation using the HeartLight(TM) Laser Balloon (endoscopically guided ablation)
Arm Title
irrigated radiofrequency current ablation
Arm Type
Active Comparator
Arm Description
Safety and efficacy of pulmonary vein isolation using the irrigated radiofrequency current ablation
Intervention Type
Device
Intervention Name(s)
HeartLight(TM) Laser Balloon
Intervention Description
With the HeartLight(TM) Laser Balloon pulmonary vein isolation is done endoscopically guided
Intervention Type
Device
Intervention Name(s)
irrigated radiofrequency current ablation
Intervention Description
The irrigated radiofrequency current ablation is used for pulmonary vein isolation
Primary Outcome Measure Information:
Title
Documented recurrence of atrial fibrillation or any atrial tachyarrhythmia >30 seconds
Time Frame
between day 90 and 365 days after index procedure
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:
18 to 80 years
persistent atrial fibrillation
failure of at least one antiarrhythmic drug
others
Exclusion Criteria:
contraindications for pulmonary vein isolation (PVI)
previous PVI attempts
inability to be treated with oral anticoagulation
presence of intracardiac thrombi
pregnancy
others
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boris Schmidt, Dr.
Organizational Affiliation
Cardioangiologisches Centrum Bethanien
Official's Role
Principal Investigator
Facility Information:
Facility Name
Na Homolce Hospital
City
Prague
ZIP/Postal Code
15030
Country
Czech Republic
Facility Name
Herz- und Gefäß-Klinik GmbH Bad Neustadt
City
Bad Neustadt
State/Province
Bavaria
ZIP/Postal Code
97616
Country
Germany
Facility Name
Rheinische Friedrich-Wilhelms-Universität Bonn
City
Bonn
State/Province
NRW
ZIP/Postal Code
53105
Country
Germany
Facility Name
Cardioangiologisches Centrum Bethanien
City
Frankfurt/Main
ZIP/Postal Code
60431
Country
Germany
Facility Name
Städtisches Klinikum Karlsruhe, Medizinische Klinik IV
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
29217521
Citation
Schmidt B, Neuzil P, Luik A, Osca Asensi J, Schrickel JW, Deneke T, Bordignon S, Petru J, Merkel M, Sediva L, Klostermann A, Perrotta L, Cano O, Chun KRJ. Laser Balloon or Wide-Area Circumferential Irrigated Radiofrequency Ablation for Persistent Atrial Fibrillation: A Multicenter Prospective Randomized Study. Circ Arrhythm Electrophysiol. 2017 Dec;10(12):e005767. doi: 10.1161/CIRCEP.117.005767.
Results Reference
derived
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Catheter Ablation of Drug-refractory Persistent Atrial Fibrillation With the HeartLight(TM) Laser Balloon in Comparison With Irrigated Radiofrequency Current Ablation
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