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

Heart Failure Clinical Trial

— MASCOT  

Official title:

Management of Atrial Fibrillation Suppression in AF-HF COmorbidity Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00187252
• Other study ID #: CR03001HF
• Status: Completed
• Phase: N/A
• Start date: September 2003
• Est. completion date: June 2008

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure
• Ventricular Dysfunction

Intervention

Device:
• Atrial Overdrive Pacing
Pacemaker/ ICD implant

Locations

Country	Name	City	State
Italy	Clinica Medica Generale e Cardiologia - Ospedale Careggi	Firenze

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of permanent atrial fibrillation		2 years