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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.
 
ClinicalTrials.gov Identifier: NCT01302470
Recruitment Status : Completed
First Posted : February 24, 2011
Last Update Posted : February 19, 2015
Sponsor:
Collaborator:
Montefiore Medical Center
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center

Tracking Information
First Submitted Date  ICMJE February 18, 2011
First Posted Date  ICMJE February 24, 2011
Last Update Posted Date February 19, 2015
Study Start Date  ICMJE February 2005
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2011)
CHF Hospitalizations & mortality [ Time Frame: one year post implant. ]
Heart failure and mortality will be assesd along with six minute hall walk tests
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Epicardial Versus Conventional Lead Placement in Cardiac Resynchronization Therapy
Official Title  ICMJE Randomized Study of Endovascular Versus Epicardial Lead Placement for Resynchronization Therapy
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cardiac Resynchronization Therapy
  • Heart Failure
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Primary epicardial placement of left ventricular lead
  • Active Comparator: Transvenous placement of CS lead
    CS lead will be placed transvenously
    Intervention: Procedure: Transvenous placement of left ventricular lead
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 13, 2012)
30
Original Estimated Enrollment  ICMJE
 (submitted: February 23, 2011)
50
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01302470
Other Study ID Numbers  ICMJE 04-052
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party St. Luke's-Roosevelt Hospital Center
Study Sponsor  ICMJE St. Luke's-Roosevelt Hospital Center
Collaborators  ICMJE Montefiore Medical Center
Investigators  ICMJE Not Provided
PRS Account St. Luke's-Roosevelt Hospital Center
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP