Catheter Ablation of Drug-refractory Persistent Atrial Fibrillation With the HeartLight(TM) Laser Balloon in Comparison With Irrigated Radiofrequency Current Ablation

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Cardioangiologisches Centrum Bethanien
Sponsor:
Information provided by (Responsible Party):
Boris Schmidt, Cardioangiologisches Centrum Bethanien
ClinicalTrials.gov Identifier:
NCT01863472
First received: May 19, 2013
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Persistent Atrial Fibrillation
Device: HeartLight(TM) Laser Balloon
Device: irrigated radiofrequency current ablation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Catheter Ablation of Drug-refractory Persistent Atrial Fibrillation With the HeartLight(TM) Laser Balloon in Comparison With Irrigated Radiofrequency Current Ablation

Resource links provided by NLM:


Further study details as provided by Cardioangiologisches Centrum Bethanien:

Primary Outcome Measures:
  • Documented recurrence of atrial fibrillation or any atrial tachyarrhythmia >30 seconds [ Time Frame: between day 90 and 365 days after index procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: June 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: HeartLight(TM) Laser Balloon
Safety and efficacy of pulmonary vein isolation using the HeartLight(TM) Laser Balloon (endoscopically guided ablation)
Device: HeartLight(TM) Laser Balloon
With the HeartLight(TM) Laser Balloon pulmonary vein isolation is done endoscopically guided
Active Comparator: irrigated radiofrequency current ablation
Safety and efficacy of pulmonary vein isolation using the irrigated radiofrequency current ablation
Device: irrigated radiofrequency current ablation
The irrigated radiofrequency current ablation is used for pulmonary vein isolation

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01863472

Contacts
Contact: Boris Schmidt, Dr +49 69945028 ext 110 b.schmidt@ccb.de

Locations
Germany
Herz- und Gefäß-Klinik GmbH Bad Neustadt Recruiting
Bad Neustadt, Bavaria, Germany, 97616
Contact: Thomas Deneke, PD Dr.    +49 9771662602    Thomas.Deneke@kardiologie-bad-neustadt.de   
Principal Investigator: Thomas Deneke, PB Dr.         
Rheinische Friedrich-Wilhelms-Universität Bonn Recruiting
Bonn, NRW, Germany, 53105
Contact: Jan Schrickel, Prof. Dr.    +49 22828714983    jan.schrickel@ukb.uni-bonn.de   
Principal Investigator: Jan Schrickel, Prof. Dr.         
Cardioangiologisches Centrum Bethanien Recruiting
Frankfurt/Main, Germany, 60431
Contact: Boris Schmidt, Dr.    +4969945028 ext 110    b.schmidt@ccb.de   
Principal Investigator: Boris Schmidt, Dr.         
Städtisches Klinikum Karlsruhe, Medizinische Klinik IV Recruiting
Karlsruhe, Germany, 76133
Contact: Armin Luik, Dr.    +49 721 974 0    armin.luik@klinikum-karlsruhe.de   
Principal Investigator: Armin Luik, Dr.         
Sponsors and Collaborators
Boris Schmidt
Investigators
Principal Investigator: Boris Schmidt, Dr. Cardioangiologisches Centrum Bethanien
  More Information

No publications provided

Responsible Party: Boris Schmidt, Arzt für Kardiologie, Cardioangiologisches Centrum Bethanien
ClinicalTrials.gov Identifier: NCT01863472     History of Changes
Other Study ID Numbers: FF20/13 Version 03
Study First Received: May 19, 2013
Last Updated: June 2, 2014
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014