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

Management of Atrial Fibrillation Suppression in AF-HF COmorbidity Therapy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00187252

Acronym

MASCOT

Enrollment

380

Registered

2005-09-16

Start date

2003-09-30

Completion date

2008-06-30

Last updated

2019-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Heart Failure, Ventricular Dysfunction

Keywords

Ventricular Dyssynchrony

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.

Interventions

DEVICEAtrial Overdrive Pacing

Pacemaker/ ICD implant

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Prevalence of permanent atrial fibrillation	2 years

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026