Prospective Registry of Epicardial LV Leads Placed During Cardiac Surgery Procedures

Completed

• Conditions: Chronic Heart Failure
• Interventions: Procedure: Epicardial left ventricular lead placement; Procedure: Transvenous left ventricular lead implant

• Registration Number: NCT00288288
• Lead Sponsor: University of Kansas

Brief 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.

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.

Study Timeline

• Study First Submitted: 2006-02-03
• Study First Submitted QC: 2006-02-03
• Study First Posted: 2006-02-07
• Study Start: 2006-03
• Study Completion: 2010-05
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-24
• Last Update Posted: 2012-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Epicardial left ventricular lead placement	Epicardial left ventricular lead placement during a clinically indicated open chest surgery
2	Transvenous left ventricular lead implant	Transvenous left ventricular lead implant during a clinically indicated CRT system implant

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States