Status:
UNKNOWN
A Prospective Randomized Study Comparing Radiofrequency Energy With Cryoenergy
Lead Sponsor:
Herz-Zentrums Bad Krozingen
Collaborating Sponsors:
CryoCath Technologies Inc.
Boston Scientific Corporation
Conditions:
Atrial Fibrillation Ablation
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Transvenous pulmonary vein (PV) isolation using radiofrequency energy is an effective treatment for atrial fibrillation (1-4). However, rare but potentially life threatening complications such as thro...
Eligibility Criteria
Inclusion
- Age between 18 and 75 years
- Symptomatic drug refractory (more than 2 antiarrhythmic drugs) paroxysmal or persistent AF
- Documentation of AF on 12 lead ECG and/ or Holter
- Left atrium of less than 55 mm
- Informed consent signed by the patient
Exclusion
- Previous Ablation or operation for AF
- Contra-indication for heart catheterisation
- Cardioversion for AF during the 2 weeks before the procedure
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2009
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00773539
Start Date
July 1 2008
End Date
August 1 2009
Last Update
October 16 2008
Active Locations (1)
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1
Herz-Zentrum
Bad Krozingen, Germany, 79189