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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31055

Enrollment

Registered

2007-11-15

Start date

2008-09-18

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

congestive heartfailure heartfailue

Interventions

Implantation of a biventricular pacemaker, with or without ICD-function. Depending on the randomization, a transvenous os surgical epicardial placement of the LV lead is performed.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Age

Design outcomes

Primary

Measure	Time frame
Degree of change in cardiac perfusion abnormalities and the relation to cardiac function.	—

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)