Prospective Registry of Epicardial LV Leads Placed During Cardiac Surgery Procedures

Chronic Heart Failure Clinical Trial

Official title:

Prospective Registry of Epicardial LV Leads Placed During Cardiac Surgery Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00288288
• Other study ID #: PROPEL
• Status: Completed
• Phase: N/A
• First received: February 3, 2006
• Last updated: September 24, 2012
• Start date: March 2006
• Est. completion date: May 2010

Study information

• Verified date: September 2012
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Heart Failure

Intervention

Procedure:
• Epicardial left ventricular lead placement
Epicardial left ventricular lead placement
• Transvenous left ventricular lead implant
Transvenous left ventricular lead implant

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Medtronic

Country where clinical trial is conducted

United States,