Cardiomyopathy
Conditions
Keywords
Heart failure, Super responder
Brief summary
The purpose of this study is to determine clinical outcomes related to deactivation of Cardiac Resynchronization Therapy device in subjects with super response.
Interventions
Cardiac Resynchronization Therapy Device pacing activity, on or off
Sponsors
Yuksek Ihtisas Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* super response to Cardiac Resynchronization Therapy * near normal Left ventricular ejection fraction * \>99% pacing
Exclusion criteria
* \<99% pacing * atrial fibrillation * ischemic cardiomyopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical/Echocardiographic outcome | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 12 months | Number of participants experiencing mortality |
| Heart failure hospitalization | 12 months | Number of participants experiencing heart failure hospitalization |
| Cardiac Resynchronization Therapy Device intervention | 12 months | Heart failure hospitalization Cardiac Resynchronization Therapy Device intervention for detected episodes. |
Outcome results
None listed