Mascot Study: Management of Atrial Fibrillation (AF) Suppression in AF-Heart Failure (HF) COmorbidity Therapy
NCT ID: NCT00187252
Last Updated: 2019-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
380 participants
INTERVENTIONAL
2003-09-30
2008-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
CRT + AF Suppression turned ON
Atrial Overdrive Pacing
Pacemaker/ ICD implant
2
CRT + AF Suppression turned OFF
Atrial Overdrive Pacing
Pacemaker/ ICD implant
Interventions
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Atrial Overdrive Pacing
Pacemaker/ ICD implant
Eligibility Criteria
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Inclusion Criteria
* 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
* Coronary artery bypass grafting (CABG) or percutaneous transluminal coronary angioplasty (PTCA) \< 3 months
* Life expectancy \< 6 months
* Permanent AF
* Pregnancy
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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St. Jude Medical
Principal Investigators
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Luigi Padeletti, MD
Role: PRINCIPAL_INVESTIGATOR
Ospedale Carregi, Firenze, Italy
Locations
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Clinica Medica Generale e Cardiologia - Ospedale Careggi
Florence, , Italy
Countries
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References
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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.
Other Identifiers
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CR03001HF
Identifier Type: -
Identifier Source: org_study_id
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