Comparison of Epicardial Versus Conventional Lead Placement in Cardiac Resynchronization Therapy (REVERT)
Primary Purpose
Cardiac Resynchronization Therapy, Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Primary epicardial placement of left ventricular lead
Transvenous placement of left ventricular lead
Sponsored by
About this trial
This is an interventional treatment trial for Cardiac Resynchronization Therapy focused on measuring biventricular pacing
Eligibility 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
Sites / Locations
- St.Lukes-Roosevelt Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Robotic placement of CS lead
Transvenous placement of CS lead
Arm Description
CS leads placed epicardially in the area of increased dyssynchrony as demonstrated by low dose dobutamine stress testing.
CS lead will be placed transvenously
Outcomes
Primary Outcome Measures
CHF Hospitalizations & mortality
Heart failure and mortality will be assesd along with six minute hall walk tests
Secondary Outcome Measures
Full Information
NCT ID
NCT01302470
First Posted
February 18, 2011
Last Updated
February 18, 2015
Sponsor
St. Luke's-Roosevelt Hospital Center
Collaborators
Montefiore Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01302470
Brief Title
Comparison of Epicardial Versus Conventional Lead Placement in Cardiac Resynchronization Therapy
Acronym
REVERT
Official Title
Randomized Study of Endovascular Versus Epicardial Lead Placement for Resynchronization Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Luke's-Roosevelt Hospital Center
Collaborators
Montefiore Medical Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Resynchronization Therapy, Heart Failure
Keywords
biventricular pacing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Robotic placement of CS lead
Arm Type
Active Comparator
Arm Description
CS leads placed epicardially in the area of increased dyssynchrony as demonstrated by low dose dobutamine stress testing.
Arm Title
Transvenous placement of CS lead
Arm Type
Active Comparator
Arm Description
CS lead will be placed transvenously
Intervention Type
Procedure
Intervention Name(s)
Primary epicardial placement of left ventricular lead
Other Intervention Name(s)
cardiac resynchronization therapy
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Transvenous placement of left ventricular lead
Other Intervention Name(s)
Cardiac resynchronization Therapy, CRT/ AICD
Intervention Description
Conventional placement of left ventricular leads performed in the electrophysiology department.
Primary Outcome Measure Information:
Title
CHF Hospitalizations & mortality
Description
Heart failure and mortality will be assesd along with six minute hall walk tests
Time Frame
one year post implant.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
St.Lukes-Roosevelt Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of Epicardial Versus Conventional Lead Placement in Cardiac Resynchronization Therapy
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