Mascot Study: Management of Atrial Fibrillation (AF) Suppression in AF-Heart Failure (HF) COmorbidity Therapy (MASCOT)

Abbott

Status: Completed

Conditions: Atrial Fibrillation; Ventricular Dysfunction; Heart Failure

Treatments: Device: Atrial Overdrive Pacing

Study type: Interventional

Funder types: Industry

Identifiers

NCT00187252

CR03001HF

Details and patient eligibility

About

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 resynchronization therapy.

Enrollment: 380 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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380 participants in 2 patient groups

1

Experimental group

Description:

CRT + AF Suppression turned ON

Treatment:

Device: Atrial Overdrive Pacing

2

Active Comparator group

Description:

CRT + AF Suppression turned OFF

Treatment:

Device: Atrial Overdrive Pacing