Comparison of Epicardial Versus Conventional Lead Placement in Cardiac Resynchronization Therapy

Not Applicable

Completed

• Conditions: Cardiac Resynchronization Therapy; Heart Failure

• Registration Number: NCT01302470
• Lead Sponsor: St. Luke's-Roosevelt Hospital Center

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 Timeline

• Study Start: 2005-02
• Study First Submitted: 2011-02-18
• Study First Submitted QC: 2011-02-23
• Study First Posted: 2011-02-24
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-18
• Last Update Posted: 2015-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
CHF Hospitalizations & mortality	one year post implant.	Heart failure and mortality will be assesd along with six minute hall walk tests

Trial Locations

Locations (1)

St.Lukes-Roosevelt Hospital; 🇺🇸 New York, New York, United States