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

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ClinicalTrials.gov Identifier: NCT00187252
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : February 12, 2009
Sponsor:
Information provided by:
St. Jude Medical

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.

Condition or disease Intervention/treatment Phase
Heart Failure Atrial Fibrillation Ventricular Dysfunction Device: Atrial Overdrive Pacing Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Management of Atrial Fibrillation Suppression in AF-HF COmorbidity Therapy
Study Start Date : September 2003
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christophe Bailleul, St. Jude Medical
ClinicalTrials.gov Identifier: NCT00187252     History of Changes
Other Study ID Numbers: CR03001HF
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: February 12, 2009
Last Verified: February 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