Prospective Registry of Epicardial LV Leads Placed During Cardiac Surgery Procedures

This study is currently recruiting participants.

Verified by University of Kansas, September 2008

First Received: February 3, 2006 Last Updated: September 15, 2008 History of Changes

Sponsors and Collaborators:	University of Kansas Berenbom, Loren, M.D. Medtronic
Information provided by:	University of Kansas
ClinicalTrials.gov Identifier:	NCT00288288

Purpose

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.

Condition	Intervention
Chronic Heart Failure	Procedure: Epicardial left ventricular lead placement Procedure: Transvenous left ventricular lead implant

MedlinePlus related topics: Heart Failure Heart Surgery Surgery

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Prospective Registry of Epicardial LV Leads Placed During Cardiac Surgery Procedures

Further study details as provided by University of Kansas:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	40
Study Start Date:	March 2006
Estimated Study Completion Date:	September 2008

Groups/Cohorts	Assigned Interventions
1 Epicardial left ventricular lead placement during a clinically indicated open chest surgery	Procedure: Epicardial left ventricular lead placement Epicardial left ventricular lead placement
2 Transvenous left ventricular lead implant during a clinically indicated CRT system implant	Procedure: Transvenous left ventricular lead implant Transvenous left ventricular lead implant

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Medical Center

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

No previous pacemaker or ICD implant
No permanent atrial fibrillation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00288288

Contacts

Contact: Kathleen Dalton, ARNP

913-588-9674

kdalton@mac.md

Locations

United States, Kansas
University of Kansas Medical Center	Recruiting
Kansas City, Kansas, United States, 66160
Contact: Kathleen M Dalton, ARNP 913-588-9674 kdalton@mac.md
Contact: Caroline W Murray 913-588-9679 cmurray@mac.md

Sponsors and Collaborators

University of Kansas

Berenbom, Loren, M.D.

Medtronic

Investigators

Principal Investigator:

Loren Berenbom, MD

University of Kansas

More Information

No publications provided

Responsible Party:	University of Kansas Medical Center ( Loren Berenbom )
Study ID Numbers:	PROPEL
Study First Received:	February 3, 2006
Last Updated:	September 15, 2008
ClinicalTrials.gov Identifier:	NCT00288288 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 07, 2009