Prospective Registry of Epicardial LV Leads Placed During Cardiac Surgery Procedures

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00288288

Enrollment

Registered

2006-02-07

Start date

2006-03-31

Completion date

2010-05-31

Last updated

2012-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Heart Failure

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.

Interventions

PROCEDUREEpicardial left ventricular lead placement

Epicardial left ventricular lead placement

PROCEDURETransvenous left ventricular lead implant

Transvenous left ventricular lead implant

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026