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CompletedNCT00288288Updated Sep 25, 2012

Prospective Registry of Epicardial LV Leads Placed During Cardiac Surgery Procedures

An observational study in Chronic Heart Failure, sponsored by University of Kansas. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-09-25.

Sponsored by University of Kansas · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study summary

The primary purpose of this study is to compare the time, risk and cost savings of 2 patient groups who receive FDA approved left ventricular pacing leads.

Read the detailed description

The purpose of this study is to: a) examine the usefulness of placing an epicardial LV lead at the time of open chest surgery in patients who are likely to benefit from a CRT system following their surgery; b) compare differences between patients who receive LV leads using the transvenous approach and those patients who receive LV leads using the epicardial approach; and c) assess the cost effectiveness of placing the LV lead via the transvenous versus the epicardial approaches.

02

Conditions studied

  • Chronic Heart Failure

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03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 40 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.

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Lead sponsor

University of Kansas is the lead sponsor of 81 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Medical Center

Inclusion criteria

  1. Left ventricular ejection fraction \< or = 35%
  2. QRS duration greater than or = to 120ms
  3. NYHA Functional Class 3 or 4
  4. Age > or = to 18 years

Exclusion criteria

Exclusion Criteria:

  1. No previous pacemaker or ICD implant
  2. No permanent atrial fibrillation
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (actual)

Groups and cohorts

  • 1

    Epicardial left ventricular lead placement during a clinically indicated open chest surgery

    Procedure: Epicardial left ventricular lead placement

  • 2

    Transvenous left ventricular lead implant during a clinically indicated CRT system implant

    Procedure: Transvenous left ventricular lead implant

Interventions

  • ProcedureEpicardial left ventricular lead placement

    Epicardial left ventricular lead placement

  • ProcedureTransvenous left ventricular lead implant

    Transvenous left ventricular lead implant

06

Study locations

1 site
  • University of Kansas Medical Center
    Kansas City, Kansas 66160, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00288288
Lead sponsor
University of Kansas
Collaborators
Medtronic
Responsible party
Loren Berenbom, MD (Principal Investigator, University of Kansas) — Principal investigator
First posted
Feb 7, 2006
Start date
Mar 2006
Completion
May 2010
Last update
Sep 25, 2012

Study contacts

Loren Berenbom, MD
principal investigator · University of Kansas Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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