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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00187252
First Posted: September 16, 2005
Last Update Posted: February 12, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
St. Jude Medical
  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
Intervention Model: Parallel Assignment
Masking: Single (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

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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 Submitted: September 13, 2005
First Posted: September 16, 2005
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