- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00187252
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
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
-
-
-
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
|
Pacemaker/ ICD implant
|
Active Comparator: 2
CRT + AF Suppression turned OFF
|
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
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
- 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.
- 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.
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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