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

Heart Failure Clinical Trial

— CONTRACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00551681
• Other study ID #: RDC-2006-04
• Status: Completed
• Phase: N/A
• First received: October 30, 2007
• Last updated: April 20, 2016
• Start date: November 2007
• Est. completion date: August 2015

Study information

• Verified date: April 2016
• Source: R&D Cardiologie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Left Ventricular Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

Device:
• biventricular pacemaker with epicardial left ventricular lead
epicardial left ventricular lead placement
• transvenous left ventricular lead placement
implantation of biventricular pacemaker with transvenous left ventricular lead placement

Locations

Country	Name	City	State
Netherlands	St Antonius Hospital	Nieuwegein	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
R&D Cardiologie

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of change in cardiac perfusion following epicardial LV lead placement, compared to transvenous LV lead placement		6 months	No
Secondary	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	No