Status:
COMPLETED
PV-Isolation With the Cryoballoon Versus RF:a Randomized Controlled Prospective Non-inferiority Trial (FreezeAF)
Lead Sponsor:
Staedtisches Klinikum Karlsruhe
Collaborating Sponsors:
Heidelberg University
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
This study is designed as a randomized, controlled, prospective, non-inferiority clinical trial, where the efficacy and safety of the cryoballoon ablation system (CE certificated) will be compared to ...
Detailed Description
Study objectives: This study is designed as a randomized, controlled, prospective, non-inferiority clinical trial, where the efficacy and safety of the cryoballoon ablation system (CE certificated) w...
Eligibility Criteria
Inclusion
- Documented paroxysmal PAF: PAF diagnosis, 2 episodes of PAF within the last 3 months, at least 1 episode of PAF must be documented.
- Age 18-75
- Documented effectiveness failure of at least 1 AAD including beta-blockers
Exclusion
- AAD usage \< 3 half life periods (except beta-blocker)
- LA size \> 55 mm
- LA thrombus
- Previous LA ablation/surgery, structural heart disease, heart failure class III-IV
- Hypertrophic cardiomyopathy
- Mitral prosthesis
- Unstable angina
- Uncontrolled hyperthyroidism
- Stroke or TIA within 6 months
- Myocardial infarction within 2 months
- Cardiac surgery within 3 months
- Thrombocytosis, thrombocytopenia
- Any condition contraindicating chronic anticoagulation
- EF \< 40%
- Pregnancy
- Life expectancy \< 1 year
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
322 Patients enrolled
Trial Details
Trial ID
NCT00774566
Start Date
October 1 2008
End Date
December 1 2014
Last Update
April 6 2021
Active Locations (1)
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1
Staedtisches Klinikum
Karlsruhe, Baden-Wurttemberg, Germany, 76133