Cardiac Resynchronization Therapy (CRT)-Narrow-dp/Dt-Study
Phase 4
Completed
- Conditions
- Heart Failure
- Interventions
- Procedure: LV dp/dt pressure measurement
- Registration Number
- NCT00821938
- Lead Sponsor
- Medtronic Bakken Research Center
- 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 as well as the positve increase of the intraoperative pressureincreasespeed in reverse remodelling and a secondary improvement of functional parameters
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DDD-ICD LV dp/dt pressure measurement - CRT-ICD LV dp/dt pressure measurement -
- Primary Outcome Measures
Name Time Method Indexed left ventricular volume 12 months
- Secondary Outcome Measures
Name Time Method NYHA-class, 6 minute hallwalk, QOL, BNP-level, echo-criteria 12 months
Trial Locations
- Locations (1)
Schuechtermann-Kliniken
🇩🇪Bad Rothenfelde, Germany