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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00187252
Other study ID # CR03001HF
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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