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NCT02247427 Clinical Trial

Clinical Outcomes Related to Cardiac Resynchronization Therapy Deactivation of Super Responders

Cardiomyopathy Clinical Trial

Official title:
Midterm Clinical Outcomes Related to Cardiac Resynchronization Therapy Deactivation of Super Responders

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02247427
Other study ID # TYIH-132
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received September 16, 2014
Last updated September 18, 2014
Start date January 2009
Est. completion date June 2014

Study information
Verified date September 2014
Source Yuksek Ihtisas Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine clinical outcomes related to deactivation of Cardiac Resynchronization Therapy device in subjects with super response.

Recruitment information / eligibility
Status Completed
Enrollment 19
Est. completion date June 2014
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria:

- super response to Cardiac Resynchronization Therapy

- near normal Left ventricular ejection fraction

- >99% pacing

Exclusion Criteria:

- <99% pacing

- atrial fibrillation

- ischemic cardiomyopathy

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Cardiac Resynchronization Therapy Device
Cardiac Resynchronization Therapy Device pacing activity, on or off

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Yuksek Ihtisas Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical/Echocardiographic outcome Clinical/Echocardiographic outcome including New York Heart Association class, 6-min walk test, Left ventricular ejection fraction, Left ventricular end- diastolic diameter, Left ventricular end-systolic volume, and Left ventricular end-systolic diameter. 12 months
Secondary Mortality Number of participants experiencing mortality 12 months
Secondary Heart failure hospitalization Number of participants experiencing heart failure hospitalization 12 months
Secondary Cardiac Resynchronization Therapy Device intervention Heart failure hospitalization Cardiac Resynchronization Therapy Device intervention for detected episodes. 12 months
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