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

February 1, 2019 updated by: Abbott Medical Devices

Management of Atrial Fibrillation Suppression in AF-HF COmorbidity Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

380

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of permanent atrial fibrillation
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Luigi Padeletti, MD, Ospedale Carregi, Firenze, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR03001HF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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