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OpenTrials
Completed

NCT Number: NCT00288288

Prospective Registry of Epicardial LV Leads Placed During Cardiac Surgery Procedures

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.

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Key information

Conditions

Chronic Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Left ventricular ejection fraction < or = 35%
  • QRS duration greater than or = to 120ms
  • NYHA Functional Class 3 or 4
  • Age > or = to 18 years

Exclusion criteria

  • No previous pacemaker or ICD implant
  • No permanent atrial fibrillation

Treatment and study plan

Epicardial left ventricular lead placement

Procedure

Epicardial left ventricular lead placement

Transvenous left ventricular lead implant

Procedure

Transvenous left ventricular lead implant

Sponsors and collaborators

Lead sponsor

University of Kansas

Other

Collaborators

  • Medtronic

Registry information

Important dates

Study start
2006
Study completion
2010
First posted
Feb 7, 2006
Registry last updated
Sep 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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