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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01302470
Recruitment Status : Completed
First Posted : February 24, 2011
Last Update Posted : February 19, 2015
Montefiore Medical Center
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cardiac Resynchronization Therapy Heart Failure Procedure: Primary epicardial placement of left ventricular lead Procedure: Transvenous placement of left ventricular lead Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Study of Endovascular Versus Epicardial Lead Placement for Resynchronization Therapy
Study Start Date : February 2005
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

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 Name: 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

Primary Outcome Measures :
  1. CHF Hospitalizations & mortality [ Time Frame: one year post implant. ]
    Heart failure and mortality will be assesd along with six minute hall walk tests

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01302470

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United States, New York
St.Lukes-Roosevelt Hospital
New York, New York, United States, 10025
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
Montefiore Medical Center
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Responsible Party: St. Luke's-Roosevelt Hospital Center Identifier: NCT01302470    
Other Study ID Numbers: 04-052
First Posted: February 24, 2011    Key Record Dates
Last Update Posted: February 19, 2015
Last Verified: February 2015
Keywords provided by St. Luke's-Roosevelt Hospital Center:
biventricular pacing
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases