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Completed

NCT Number: NCT01302470

Comparison of Epicardial Versus Conventional Lead Placement in Cardiac Resynchronization Therapy

The primary goal of this study is to evaluate the use of robotically -assisted device leads as a primary strategy for heart resynchronization.This trials aims to compare transvenous lead placement with robotic lead placement for cardiac resynchronization therapy.

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Key information

Conditions

Cardiac Resynchronization Therapy Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St.Lukes-Roosevelt Hospital

New York, 10025, United States

About this study

A secondary goal is to explore the link between efficacy of CRT and inotropic contractile reserve as measured by dobutamine stress echocardiography.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Symptomatic NYHA class III or IV heart failure from idiopathic or ischemic heart failure
  • QRS interval greater than or equal to 130 msec
  • Left ventricular end diastolic diameter greater than or equal to 55 mm
  • left ventricular ejection fraction less than or equal to 35
  • Willingness to participate

Exclusion criteria

  • Acute renal failure; active GI bleeding; unexplained fever which may be due to an infection
  • untreated active infection
  • acute stroke
  • severe uncontrolled systemic hypertension
  • severe systemic electrolyte imbalance
  • severe concomitant illness that drastically shortens life expectancy
  • severe coagulopathy
  • history of severe COPD and inability to tolerate single lung ventilation
  • History of prior left sided thoracotomy
  • history of recent intravenous drug use
  • concomitant psychiatric diagnosis that impairs patient's ability to comply with study protocol
  • participation in another investigational protocol

Treatment and study plan

Primary epicardial placement of left ventricular lead

Procedure

Epicardial leads will be placed on the left ventricle in the area of the most dyssynchrony . the leads will be attached to a Medtronic Cardiac resynchronization/ AICD/ device

Other names: cardiac resynchronization therapy

Transvenous placement of left ventricular lead

Procedure

Conventional placement of left ventricular leads performed in the electrophysiology department.

Other names: Cardiac resynchronization Therapy, CRT/ AICD

Primary outcomes

  1. CHF Hospitalizations & mortality

    Time frame: one year post implant.

    Heart failure and mortality will be assesd along with six minute hall walk tests

Sponsors and collaborators

Lead sponsor

St. Luke's-Roosevelt Hospital Center

Other

Collaborators

  • Montefiore Medical Center

Registry information

Official study title

Randomized Study of Endovascular Versus Epicardial Lead Placement for Resynchronization Therapy

Acronym: REVERT

Important dates

Study start
2005
Primary completion
2012
Study completion
2012
First posted
Feb 24, 2011
Registry last updated
Feb 19, 2015

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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