Prospective Registry of Epicardial LV Leads Placed During Cardiac Surgery Procedures

Kansas Board of Regents

Status: Completed

Conditions: Chronic Heart Failure

Treatments: Procedure: Transvenous left ventricular lead implant; Procedure: Epicardial left ventricular lead placement

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00288288

PROPEL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

1

Description:

Epicardial left ventricular lead placement during a clinically indicated open chest surgery

Treatment:

Procedure: Epicardial left ventricular lead placement

2

Description:

Transvenous left ventricular lead implant during a clinically indicated CRT system implant

Treatment:

Procedure: Transvenous left ventricular lead implant