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
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 22, 2014