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

NCT ID: NCT00551681

Last Updated: 2016-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2015-08-31

Brief Summary

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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

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Conditions

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Left Ventricular Dysfunction Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Epicardial left ventricular lead placement

Group Type ACTIVE_COMPARATOR

biventricular pacemaker with epicardial left ventricular lead

Intervention Type DEVICE

epicardial left ventricular lead placement

2

transvenous left ventricular lead

Group Type ACTIVE_COMPARATOR

transvenous left ventricular lead placement

Intervention Type DEVICE

implantation of biventricular pacemaker with transvenous left ventricular lead placement

Interventions

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biventricular pacemaker with epicardial left ventricular lead

epicardial left ventricular lead placement

Intervention Type DEVICE

transvenous left ventricular lead placement

implantation of biventricular pacemaker with transvenous left ventricular lead placement

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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R&D Cardiologie

OTHER

Sponsor Role lead

Responsible Party

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Vincent van Dijk

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lucas VA Boersma, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

St. Antonius Hospital

Locations

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St Antonius Hospital

Nieuwegein, Utrecht, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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RDC-2006-04

Identifier Type: -

Identifier Source: org_study_id

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