Effects of Left Ventricular Pacing Optimilization on Card... | NCT00551681

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

NCT00551681

Sponsor

R&D Cardiologie

Status

Completed

Last Update Posted

Apr 21, 2016Estimated

Enrollment

52Actual

Phase

Not Applicable

Conditions

Left Ventricular Dysfunction
Heart Failure

Interventions

biventricular pacemaker with epicardial left ventricular lead
transvenous left ventricular lead placement

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Feb 2015Actual

Completion Date

Aug 2015Actual

First Submitted Date

Oct 30, 2007

First Submission Date that Met QC Criteria

Oct 30, 2007

First Posted Date

Oct 31, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2016

Last Update Posted Date

Apr 21, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Epicardial left ventricular lead placement	Device: biventricular pacemaker with epicardial left ventricular lead
2	Active Comparator	transvenous left ventricular lead	Device: transvenous left ventricular lead placement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
biventricular pacemaker with epicardial left ventricular lead	Device	epicardial left ventricular lead placement	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Degree of change in cardiac perfusion following epicardial LV lead placement, compared to transvenous LV lead placement		6 months

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lucas VA Boersma, MD, PHD	St. Antonius Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Antonius Hospital		Nieuwegein	Utrecht	3435 CM	Netherlands

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D018754	Ventricular Dysfunction
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Term
D018487	Ventricular Dysfunction, Left
D006333	Heart Failure