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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boris Schmidt, Cardioangiologisches Centrum Bethanien
ClinicalTrials.gov Identifier:
NCT01863472
First received: May 19, 2013
Last updated: December 23, 2015
Last verified: December 2015
  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: December 2016
Estimated Primary Completion Date: August 2016 (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   (Adult, Senior)
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

Locations
Czech Republic
Na Homolce Hospital
Prague, Czech Republic, 15030
Germany
Herz- und Gefäß-Klinik GmbH Bad Neustadt
Bad Neustadt, Bavaria, Germany, 97616
Rheinische Friedrich-Wilhelms-Universität Bonn
Bonn, NRW, Germany, 53105
Cardioangiologisches Centrum Bethanien
Frankfurt/Main, Germany, 60431
Städtisches Klinikum Karlsruhe, Medizinische Klinik IV
Karlsruhe, Germany, 76133
Spain
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Sponsors and Collaborators
Boris Schmidt
Investigators
Principal Investigator: Boris Schmidt, Dr. Cardioangiologisches Centrum Bethanien
  More Information

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: December 23, 2015
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 August 25, 2016