Effects of left ventricular pacing optimalisation on cardiac perfusion, contractile force, and clinical performance in patients with ventricular dysfunction and heart failure

Recruiting

Conditions: heartfailue
10019280
congestive heartfailure

Registration Number: NL-OMON31055

Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 52

Inclusion Criteria

Heart failure, New York Heart Association (NYHA) class III or IV
QRS-duration >120 ms, or when paced > 200 ms on 12-lead ecg
left bundle branch block on ecg
LVEF at most 35%
Dyssynchrony on echocardiography
Optimal medical treatment for congestive heart failure

Exclusion Criteria

Age < 18 years
Severe heart failure with life expectancy < 6 months
Permanent or persistent atrial fibrillation
Indication for cardiac surgery within 6 months
Life expectancy < 1 year
Contraindications for anesthesia
Participation in another clinical trial
Pregnancy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Degree of change in cardiac perfusion abnormalities and the relation to cardiac<br /><br>function.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Determination of the diagnostic value of TDI, 2D- and 3D-echocardiography to<br /><br>predict the optimal site of LV stimulation in BIV paced patients to support and<br /><br>optimize pacing therapy.<br /><br>Change in clinical status.<br /><br>Improvement of NYHA classification.<br /><br>Difference in QRS duration on the ECG.<br /><br>Improvement of 6MWT.<br /><br>Improvement in QOL score.<br /><br>Changes in biomarkers (ANP, and pro-BNP).<br /><br>Determination of the feasibility of epicardial LV lead placement at the site of<br /><br>maximum dyssynchrony.</p><br>