Comparison of Epicardial Versus Conventional Lead Placement in Cardiac Resynchronization Therapy

Completed · Not applicable

Conditions studied: Cardiac Resynchronization Therapy, Heart Failure

In brief

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.

Key facts

Study ID

NCT01302470

Run by

St. Luke's-Roosevelt Hospital Center

People needed

30

Starts

2005-02-01

Expected to finish

2012-03-01

Last updated by the study team

2015-02-19

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• St.Lukes-Roosevelt Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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