Status:
COMPLETED
Real-Time Assessment of Cryoballoon Pulmonary Vein Isolation Using a Novel Circular Mapping Catheter
Lead Sponsor:
Heidelberg University
Collaborating Sponsors:
Medtronic
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Background: Atrial fibrillation (AF) is the most frequent sustained cardiac arrhythmia, impairs quality of life and increases stroke risk and mortality. Recent clinical experience with the Arctic Fron...
Detailed Description
A total of 40 patients scheduled for a first ablation of paroxysmal AF will be included. All study subjects will undergo cryoablation using the 28 mm Arctic Front™ Cryoablation Catheter. A double tran...
Eligibility Criteria
Inclusion
- Documented paroxysmal atrial fibrillation
- ≥18 and ≤75 years of age
- Failure of one or more antiarrhythmic drugs
- Referral for a pulmonary vein isolation catheter ablation procedure to treat atrial fibrillation
Exclusion
- Previous ablation of atrial fibrillation
- Documented left atrial thrombus
- Irregular pulmonary vein anatomy according to transesophageal echocardiography
- Atrial fibrillation secondary to reversible cause
- Amiodarone therapy in the previous 6 months
- Cardiac surgery within the prior 6 months
- Myocardial infarction within the previous 2 months
- Ejection fraction \< 40%
- NYHA class III or IV
- Moderate to severe valvular heart disease
- Previous valve replacement
- Pacemaker or implantable cardioverter defibrillator placement in the prior 3 months
- History of stroke or TIA within the previous 12 months
- Left atrial size ≥ 50 mm
- Contraindication for anticoagulation medication
- Life expectancy of less than 12 months
- Pregnancy
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01448265
Start Date
September 1 2011
End Date
July 1 2013
Last Update
July 25 2013
Active Locations (1)
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1
Department of Cardiology, University of Heidelberg
Heidelberg, Germany, 69120