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

This study has been completed.
Sponsor:
Information provided by:
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00187252
First received: September 13, 2005
Last updated: February 11, 2009
Last verified: February 2009
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional 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
Study First Received: September 13, 2005
Last Updated: February 11, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by St. Jude Medical:
Ventricular Dyssynchrony

Additional relevant MeSH terms:
Atrial Fibrillation
Heart Failure
Ventricular Dysfunction
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014