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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014