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

St. Luke's-Roosevelt Hospital Center

Status

Completed

Conditions

Heart Failure

Cardiac Resynchronization Therapy

Treatments

Procedure: Transvenous placement of left ventricular lead

Procedure: Primary epicardial placement of left ventricular lead

Study type

Interventional

Funder types

Other

Identifiers

NCT01302470

04-052

Details and patient eligibility

About

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.

Full description

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

Enrollment

30 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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