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Prospective Registry of Epicardial LV Leads Placed During Cardiac Surgery Procedures

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Loren Berenbom, MD, University of Kansas
ClinicalTrials.gov Identifier:
NCT00288288
First received: February 3, 2006
Last updated: September 24, 2012
Last verified: September 2012
History of Changes
  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

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Kansas:

Enrollment: 40
Study Start Date: March 2006
Study Completion Date: May 2010
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:

  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:

  1. No previous pacemaker or ICD implant
  2. No permanent atrial fibrillation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00288288

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas
Medtronic
Investigators
Principal Investigator: Loren Berenbom, MD University of Kansas
  More Information

No publications provided

Responsible Party: Loren Berenbom, MD, Principal Investigator, University of Kansas
ClinicalTrials.gov Identifier: NCT00288288     History of Changes
Other Study ID Numbers: PROPEL
Study First Received: February 3, 2006
Last Updated: September 24, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013