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

This study has been completed.
Sponsor:
Collaborator:
Montefiore Medical Center
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT01302470
First received: February 18, 2011
Last updated: December 13, 2012
Last verified: June 2011
History of Changes
  Purpose

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 Intervention
Cardiac Resynchronization Therapy
Heart Failure
 Procedure: Primary epicardial placement of left ventricular lead
Procedure: Transvenous placement of left ventricular lead

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Study of Endovascular Versus Epicardial Lead Placement for Resynchronization Therapy

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:
  • CHF Hospitalizations & mortality [ Time Frame: one year post implant. ] [ Designated as safety issue: No ]
    Heart failure and mortality will be assesd along with six minute hall walk tests


Enrollment: 30
Study Start Date: February 2005
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • CRT/ AICD

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302470

Locations
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
  More Information

No publications provided

Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT01302470     History of Changes
Other Study ID Numbers: 04-052
Study First Received: February 18, 2011
Last Updated: December 13, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by St. Luke's-Roosevelt Hospital Center:
biventricular pacing

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013