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

Abbott Medical Devices380 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

380

Conditions

Heart Failure Atrial Fibrillation Ventricular Dysfunction

Interventions

Atrial Overdrive PacingDEVICE

Pacemaker/ ICD implant

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Clinica Medica Generale e Cardiologia - Ospedale Careggi

Florence, Italy

Outcomes

Primary Outcomes

Prevalence of permanent atrial fibrillation

Time frame: 2 years

Data from ClinicalTrials.gov

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