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Feasibility Of continuous non-invasive blood pressure measurement in cardiac Resynchronization ThErapy

Completed
Conditions
failure of pumpfunction of the heart
Heart failure
10019280
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
Inclusion Criteria

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%

Exclusion Criteria

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
NameTimeMethod
<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
NameTimeMethod
<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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