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Prospective Registry of Epicardial LV Leads Placed During Cardiac Surgery Procedures

NCT ID: NCT00288288

Last Updated: 2012-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-03-31

Study Completion Date

2010-05-31

Brief Summary

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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

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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.

Conditions

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Chronic Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

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

Epicardial left ventricular lead placement

Intervention Type PROCEDURE

Epicardial left ventricular lead placement

2

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

Transvenous left ventricular lead implant

Intervention Type PROCEDURE

Transvenous left ventricular lead implant

Interventions

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Epicardial left ventricular lead placement

Epicardial left ventricular lead placement

Intervention Type PROCEDURE

Transvenous left ventricular lead implant

Transvenous left ventricular lead implant

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

University of Kansas

OTHER

Sponsor Role lead

Responsible Party

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Loren Berenbom, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Loren Berenbom, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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PROPEL

Identifier Type: -

Identifier Source: org_study_id