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

Not Applicable

Completed

• Conditions: Heart Failure; Atrial Fibrillation; Ventricular Dysfunction
• Interventions: Device: Atrial Overdrive Pacing

• Registration Number: NCT00187252
• Lead Sponsor: Abbott Medical Devices

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 resynchronization therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 380

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Atrial Overdrive Pacing	CRT + AF Suppression turned OFF
1	Atrial Overdrive Pacing	CRT + AF Suppression turned ON

Primary Outcome Measures

Name	Time	Method
Prevalence of permanent atrial fibrillation	2 years

Trial Locations

Locations (1)

Clinica Medica Generale e Cardiologia - Ospedale Careggi; 🇮🇹 Firenze, Italy