Feasibility Of continuous non-invasive blood pressure measurement in cardiac Resynchronization ThErapy
- Conditions
- failure of pumpfunction of the heartHeart failure10019280
- Registration Number
- NL-OMON36535
- Lead Sponsor
- Sint Antonius Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
1) End stage heart failure with NYHA class II, III or IV despite optimal medical treatment 2) QRS duration > 120msec for patients in NYHA class III or IV, QRS duration > 150msec for patients in NYHA class II
3) Left ventricular ejection fraction < 35%
1) Age < 18 years
2) Planned revascularization therapy or reparative cardiac surgery <6 months
3) Expected heart transplantation <1 year
4) Severe heart failure with short (<6 months) life expectancy
5) Chronic atrial fibrillation
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Difference of 3.5% in left ventricular ejection fraction between both<br /><br>strategies measured by 3-D echocardiography.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Changes in NYHA classification, NT-pro-BNP, 6-MWT, and QOL score assessed by the<br /><br>Minnesota Living with Heart Failure questionnaire, LVEDD, LVESD, LVEDV and<br /><br>LVESV, MR, incidence of ventriculartachycardia<br /><br>or fibrillation (VT, VF), ICD delivered antitachycardia pacing (ATP) and<br /><br>shocks, days of hospitalization<br /><br>for or associated with worsening HF and mortality of any cause.</p><br>
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