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Prospective Registry of Epicardial LV Leads Placed During Cardiac Surgery Procedures

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00288288
First Posted: February 7, 2006
Last Update Posted: September 25, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtronic
Information provided by (Responsible Party):
Loren Berenbom, MD, University of Kansas
  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

Further study details as provided by Loren Berenbom, MD, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Medical Center
  More Information

Responsible Party: Loren Berenbom, MD, Principal Investigator, University of Kansas
ClinicalTrials.gov Identifier: NCT00288288     History of Changes
Other Study ID Numbers: PROPEL
First Submitted: February 3, 2006
First Posted: February 7, 2006
Last Update Posted: September 25, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases