NCT00551681

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2007

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

April 21, 2016

Status Verified

April 1, 2016

Enrollment Period

7.3 years

First QC Date

October 30, 2007

Last Update Submit

April 20, 2016

Conditions

Left Ventricular DysfunctionHeart Failure

Keywords

cardiac resynchronisation therapyepicardial leadcoronary sinus

Outcome Measures

Primary Outcomes (1)

  • Degree of change in cardiac perfusion following epicardial LV lead placement, compared to transvenous LV lead placement

    6 months

Secondary Outcomes (1)

  • 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

Study Arms (2)

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

biventricular pacemaker with epicardial left ventricular leadDEVICE

epicardial left ventricular lead placement

1
transvenous left ventricular lead placementDEVICE

implantation of biventricular pacemaker with transvenous left ventricular lead placement

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Antonius Hospital

Nieuwegein, Utrecht, 3435 CM, Netherlands

Location

MeSH Terms

Conditions

Ventricular Dysfunction, LeftHeart Failure

Condition Hierarchy (Ancestors)

Ventricular DysfunctionHeart DiseasesCardiovascular Diseases

Study Officials

  • Lucas VA Boersma, MD, PHD

    St. Antonius Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 30, 2007

First Posted

October 31, 2007

Study Start

November 1, 2007

Primary Completion

February 1, 2015

Study Completion

August 1, 2015

Last Updated

April 21, 2016

Record last verified: 2016-04

Locations

NL(1)