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

Primary Purpose

Heart Failure, Atrial Fibrillation, Ventricular Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Atrial Overdrive Pacing
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Ventricular Dyssynchrony

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinica Medica Generale e Cardiologia - Ospedale Careggi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

CRT + AF Suppression turned ON

CRT + AF Suppression turned OFF

Outcomes

Primary Outcome Measures

Prevalence of permanent atrial fibrillation

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
February 1, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00187252
Brief Title
Mascot Study: Management of Atrial Fibrillation (AF) Suppression in AF-Heart Failure (HF) COmorbidity Therapy
Acronym
MASCOT
Official Title
Management of Atrial Fibrillation Suppression in AF-HF COmorbidity Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Atrial Fibrillation, Ventricular Dysfunction
Keywords
Ventricular Dyssynchrony

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
380 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
CRT + AF Suppression turned ON
Arm Title
2
Arm Type
Active Comparator
Arm Description
CRT + AF Suppression turned OFF
Intervention Type
Device
Intervention Name(s)
Atrial Overdrive Pacing
Intervention Description
Pacemaker/ ICD implant
Primary Outcome Measure Information:
Title
Prevalence of permanent atrial fibrillation
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luigi Padeletti, MD
Organizational Affiliation
Ospedale Carregi, Firenze, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica Medica Generale e Cardiologia - Ospedale Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
15450280
Citation
Padeletti L, Musilli N, Porciani MC, Colella A, Di Biase L, Ricciardi G, Pieragnoli P, Michelucci A, Gensini G. Atrial fibrillation and cardiac resynchronization therapy: the MASCOT study. Europace. 2004 Sep;5 Suppl 1:S49-54. doi: 10.1016/j.eupc.2004.07.007.
Results Reference
background
PubMed Identifier
18760135
Citation
Padeletti L, Muto C, Maounis T, Schuchert A, Bongiorni MG, Frank R, Vesterlund T, Brachmann J, Vicentini A, Jauvert G, Tadeo G, Gras D, Lisi F, Dello Russo A, Rey JL, Boulogne E, Ricciardi G; Management of Atrial fibrillation Suppression in AF-HF COmorbidity Therapy Study Group. Atrial fibrillation in recipients of cardiac resynchronization therapy device: 1-year results of the randomized MASCOT trial. Am Heart J. 2008 Sep;156(3):520-6. doi: 10.1016/j.ahj.2008.04.013. Epub 2008 Jul 7.
Results Reference
derived

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

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