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

Tracking Information
First Received Date ^ICMJE	February 18, 2011
Last Updated Date	December 13, 2012
Start Date ^ICMJE	February 2005
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. ] [ Designated as safety issue: No ] Heart failure and mortality will be assesd along with six minute hall walk tests
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01302470 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	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	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 Arm (s)	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
Enrollment ^ICMJE	30
Completion Date	March 2012
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
Gender	Both
Ages	18 Years to 85 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01302470
Other Study ID Numbers ^ICMJE	04-052
Has Data Monitoring Committee	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
Information Provided By	St. Luke's-Roosevelt Hospital Center
Verification Date	June 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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