Status:
TERMINATED
Surgical or Catheter Ablation of Lone Atrial Fibrillation (AF) Patients
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Prospective randomized interventional trial comparing the efficacy of circumferential pulmonary vein ostia ablation using surgical versus catheter techniques in the treatment of paroxysmal atrial fibr...
Detailed Description
Title: Surgical or Catheter Ablation in patients with Lone Atrial Fibrillation: determination of acute and long term SUCCESS (SCALAF-success trial). Background: Anti-arrhythmic drugs are used in dail...
Eligibility Criteria
Inclusion
- Patient has documented Paroxysmal AF as defined by the ACC/AHA/ESC guidelines
- Minimal one documented AF episode in the last 6 months
- Refractory to minimal two Class I or III anti-arrhythmic drug
- Age \> 18 years
- Signed and dated the Patient Informed Consent.
- Patient can tolerate anti-coagulation therapy (Warfarin/Coumadin)
Exclusion
- Patient has a structural heart disease
- Ejection fraction \< 40 %
- Echocardiographic evidence for a left atrium \> 45 mm (parasternal axis)
- Patients on amiodarone, or patients known to be intolerant for amiodarone
- Dextrocardia, current endocarditis, systemic infection, renal failure
- Patient has known cerebrovascular disease, including a history of stroke, CVA or TIA
- Pregnancy at enrolment; or planned pregnancy within the follow up period
- Patient has a life expectancy less than 1 year
- The subject is participating in another device or drug study
- The patient is unable and/or unwilling to cooperate with study procedures or required follow up visits
- Echocardiographic (TTE) evidence for presence of left atrial thrombus
- Previous (cardio-) thoracic surgery
- Previous left atrial ablation
- Patients with permanent or persistent AF
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00703157
Start Date
November 1 2007
End Date
November 1 2016
Last Update
May 16 2017
Active Locations (1)
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1
Isala Klinieken
Zwolle, Netherlands, 8011 JW