Effects of Left Ventricular Pacing Optimilization on Cardiac Perfusion, Contractile Force, and Clinical Performance in Patients With Ventricular Dysfunction and Heart Failure

Not Applicable

Completed

• Conditions: Left Ventricular Dysfunction; Heart Failure
• Interventions: Device: biventricular pacemaker with epicardial left ventricular lead; Device: transvenous left ventricular lead placement

• Registration Number: NCT00551681
• Lead Sponsor: R&D Cardiologie

Brief Summary

To compare a surgical approach of LV lead placement for BIV pacing with the conventional transvenous approach by assessment of differences on the effects on cardiac perfusion and relate this to the clinical cardiac function.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-10-30
• Study First Submitted QC: 2007-10-30
• Study First Posted: 2007-10-31
• Study Start: 2007-11
• Primary Completion: 2015-02
• Study Completion: 2015-08
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-20
• Last Update Posted: 2016-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Heart failure NYHA III or IV
• QRS duration >120msec or, when paced > 200msec on 12-lead ECG
• LBBB on ecg
• LV ejection fraction 35% or less
• LV dyssynchony on echocardiography

Exclusion Criteria

• Severe (drug refractory) heart failure with short (<6 months) life expectancy.
• Permanent or persistent atrial fibrillation
• Other indications for cardiac surgery within 6 months
• Life expectancy less than one year due to other conditions
• Major contra-indication for general anaesthesia
• Participation in another study
• Pregnancy or the desire to become pregnant during the follow up of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	biventricular pacemaker with epicardial left ventricular lead	Epicardial left ventricular lead placement
2	transvenous left ventricular lead placement	transvenous left ventricular lead

Primary Outcome Measures

Name	Time	Method
Degree of change in cardiac perfusion following epicardial LV lead placement, compared to transvenous LV lead placement	6 months

Secondary Outcome Measures

Name	Time	Method
Resynchronization of the LV, measured with TDI, 2D- and 3D-echocardiography, in patients with epicardial LV lead placement, compared to transvenous LV lead placement	6 months

Trial Locations

Locations (1)

St Antonius Hospital; 🇳🇱 Nieuwegein, Utrecht, Netherlands