Status:
COMPLETED
Cardiac Resynchronization Therapy (CRT)-Narrow-dp/Dt-Study
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Collaborating Sponsors:
Medtronic
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Goal is to examine the efficy of Cardiac Resynchronization Therapy in heart failure patients with narrow QRS complex and optimized medical treatment but echocardiographic desynchronization detection a...
Eligibility Criteria
Inclusion
- EF \< 35%
- CHD or dilate cardiomyopathy
- sinus rhythm
- NYHA III (or IV but stable recompenstated)
- QRS \< 120 ms 2-3 of the following:
- LV-fillingtime \< 40% of the cyclelength
- TDI septal-lateral (LV basal) \> 60ms
- 2D-Strain-Score \> 9 points
Exclusion
- tricuspid or artificial valve
- AV block II or III or PQ time \> 250ms
- revasculisation or condition after cardiac surgery \< 3 months
- myocardial infarction or bypass OP \< 3 months
- hytertrphic obstructive cardiomyopathy, constrictive pericarditis
- intravenous catecholamines because of HF
- manifeste hyperthyreoses
- kidney failure (creatine \>2,5 mg/dl)
- no written informed consent
- no compliance
- participation in another study
- life expectancy \< 1 year
- patients \< 18 years
- pragnancy or no safe contraception
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00821938
Start Date
November 1 2008
End Date
July 1 2016
Last Update
July 3 2025
Active Locations (1)
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1
Schuechtermann-Kliniken
Bad Rothenfelde, Germany