Status:
COMPLETED
Mascot Study: Management of Atrial Fibrillation (AF) Suppression in AF-Heart Failure (HF) COmorbidity Therapy
Lead Sponsor:
Abbott Medical Devices
Conditions:
Heart Failure
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate whether adding AF Suppression™ to cardiac resynchronization therapy (CRT) improves the prognosis of heart failure patients benefiting from cardiac resynchroniz...
Eligibility Criteria
Inclusion
- HF patients
- New York Heart Association (NYHA) III - IV
- Spontaneous QRS ≥130 ms and/or mechanical interventricular delay \> 50 ms
- Left ventricular ejection fraction (LVEF) ≤ 35%
- Left ventricular end diastolic diameter (LVEDD) ≥ 55 mm
- Optimized medical regimen
- Age \> 18 years
Exclusion
- Unstable angina or acute myocardial infarction (MI) (\< 3 months)
- Coronary artery bypass grafting (CABG) or percutaneous transluminal coronary angioplasty (PTCA) \< 3 months
- Life expectancy \< 6 months
- Permanent AF
- Pregnancy
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2008
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT00187252
Start Date
September 1 2003
End Date
June 1 2008
Last Update
February 4 2019
Active Locations (1)
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1
Clinica Medica Generale e Cardiologia - Ospedale Careggi
Florence, Italy, 50134