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

This study has been completed.
Information provided by:
St. Jude Medical Identifier:
First received: September 13, 2005
Last updated: February 11, 2009
Last verified: February 2009
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
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: Management of Atrial Fibrillation Suppression in AF-HF COmorbidity Therapy

Resource links provided by NLM:

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Prevalence of permanent atrial fibrillation [ Time Frame: 2 years ]

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00187252

Clinica Medica Generale e Cardiologia - Ospedale Careggi
Firenze, Italy, 50134
Sponsors and Collaborators
St. Jude Medical
Principal Investigator: Luigi Padeletti, MD Ospedale Carregi, Firenze, Italy
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Christophe Bailleul, St. Jude Medical Identifier: NCT00187252     History of Changes
Other Study ID Numbers: CR03001HF
Study First Received: September 13, 2005
Last Updated: February 11, 2009

Keywords provided by St. Jude Medical:
Ventricular Dyssynchrony

Additional relevant MeSH terms:
Heart Failure
Atrial Fibrillation
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes processed this record on May 22, 2017