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

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

This study has been completed.

First Received on September 13, 2005. Last Updated on February 11, 2009 History of Changes

Sponsor:	St. Jude Medical
Information provided by:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT00187252

Purpose

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.

Condition	Intervention
Heart Failure Atrial Fibrillation Ventricular Dysfunction	Device: Atrial Overdrive Pacing

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Management of Atrial Fibrillation Suppression in AF-HF COmorbidity Therapy

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Heart Failure

U.S. FDA Resources

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:

Prevalence of permanent atrial fibrillation [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	380
Study Start Date:	September 2003
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 CRT + AF Suppression turned ON	Device: Atrial Overdrive Pacing Pacemaker/ ICD implant
Active Comparator: 2 CRT + AF Suppression turned OFF	Device: Atrial Overdrive Pacing Pacemaker/ ICD implant

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187252

Locations

Italy
Clinica Medica Generale e Cardiologia - Ospedale Careggi
Firenze, Italy, 50134

Sponsors and Collaborators

St. Jude Medical

Investigators

Principal Investigator:

Luigi Padeletti, MD

Ospedale Carregi, Firenze, Italy

More Information

Publications:

Padeletti L, Musilli N, Porciani MC, Colella A, Di Biase L, Ricciardi G, Pieragnoli P, Michelucci A, Gensini G. Atrial fibrillation and cardiac resynchronization therapy: the MASCOT study. Europace. 2004 Sep;5 Suppl 1:S49-54.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Padeletti L, Muto C, Maounis T, Schuchert A, Bongiorni MG, Frank R, Vesterlund T, Brachmann J, Vicentini A, Jauvert G, Tadeo G, Gras D, Lisi F, Dello Russo A, Rey JL, Boulogne E, Ricciardi G; Management of Atrial fibrillation Suppression in AF-HF COmorbidity Therapy Study Group. Atrial fibrillation in recipients of cardiac resynchronization therapy device: 1-year results of the randomized MASCOT trial. Am Heart J. 2008 Sep;156(3):520-6. Epub 2008 Jul 7.

Responsible Party:	Christophe Bailleul, St. Jude Medical
ClinicalTrials.gov Identifier:	NCT00187252 History of Changes
Other Study ID Numbers:	CR03001HF
Study First Received:	September 13, 2005
Last Updated:	February 11, 2009
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by St. Jude Medical:

Ventricular Dyssynchrony

Additional relevant MeSH terms:

Atrial Fibrillation
Heart Failure
Ventricular Dysfunction
Arrhythmias, Cardiac

Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012