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

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

This study is not yet open for participant recruitment.
Verified by R&D Cardiologie, October 2007

Sponsored by:	R&D Cardiologie
Information provided by:	R&D Cardiologie
ClinicalTrials.gov Identifier:	NCT00551681

Purpose

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.

Condition	Intervention
Left Ventricular Dysfunction Heart Failure	Device: biventricular pacemaker with epicardial left ventricular lead Device: transvenous left ventricular lead placement

MedlinePlus related topics:

Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by R&D Cardiologie:

Primary Outcome Measures:

Degree of change in cardiac perfusion following epicardial LV lead placement, compared to transvenous LV lead placement [ Time Frame: 6 months ]

Secondary Outcome Measures:

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

Estimated Enrollment:	52
Study Start Date:	November 2007
Estimated Study Completion Date:	April 2009

Arms	Assigned Interventions
1: Active Comparator Epicardial left ventricular lead placement	Device: biventricular pacemaker with epicardial left ventricular lead epicardial left ventricular lead placement
2: Active Comparator transvenous left ventricular lead	Device: transvenous left ventricular lead placement implantation of biventricular pacemaker with transvenous left ventricular lead placement

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00551681

Locations


Netherlands, Utrecht
	St Antonius Hospital	Not yet recruiting
	Nieuwegein, Utrecht, Netherlands, 3435 CM
	Contact: Vincent F van Dijk, MD 0031 30 6092278 v.van.dijk@antonius.net
	Principal Investigator: Lucas VA Boersma, MD, PHD

Sponsors and Collaborators

R&D Cardiologie

Investigators


Principal Investigator:	Lucas VA Boersma, MD, PHD	St. Antonius Hospital

More Information

Study ID Numbers:	RDC-2006-04
First Received:	October 30, 2007
Last Updated:	October 30, 2007
ClinicalTrials.gov Identifier:	NCT00551681
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by R&D Cardiologie:

cardiac resynchronisation therapy

epicardial lead

coronary sinus

Study placed in the following topic categories:

Ventricular Dysfunction

Heart Failure

Heart Diseases

Ventricular Dysfunction, Left

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 17, 2008