Comparison of Epicardial Versus Conventional Lead Placement in Cardiac Resynchronization Therapy (REVERT)

February 18, 2015 updated by: St. Luke's-Roosevelt Hospital Center

Randomized Study of Endovascular Versus Epicardial Lead Placement for 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10025
        • St.Lukes-Roosevelt Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Robotic placement of CS lead
CS leads placed epicardially in the area of increased dyssynchrony as demonstrated by low dose dobutamine stress testing.
Procedure: Primary epicardial placement of left ventricular lead
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
Active Comparator: Transvenous placement of CS lead
CS lead will be placed transvenously
Procedure: Transvenous placement of left ventricular lead
Conventional placement of left ventricular leads performed in the electrophysiology department.
Other Names:
  • Cardiac resynchronization Therapy
  • CRT/ AICD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CHF Hospitalizations & mortality
Time Frame: one year post implant.
Heart failure and mortality will be assesd along with six minute hall walk tests
one year post implant.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Luke's-Roosevelt Hospital Center

Collaborators

Montefiore Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

February 18, 2011

First Submitted That Met QC Criteria

February 23, 2011

First Posted (Estimate)

February 24, 2011

Study Record Updates

Last Update Posted (Estimate)

February 19, 2015

Last Update Submitted That Met QC Criteria

February 18, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-052

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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