Comparison of Epicardial Versus Conventional Lead Placement in Cardiac Resynchronization Therapy

Not Applicable

Completed

• Conditions: Cardiac Resynchronization Therapy; Heart Failure
• Interventions: Procedure: Primary epicardial placement of left ventricular lead; Procedure: Transvenous placement of left ventricular lead

• 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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robotic placement of CS lead	Primary epicardial placement of left ventricular lead	CS leads placed epicardially in the area of increased dyssynchrony as demonstrated by low dose dobutamine stress testing.
Transvenous placement of CS lead	Transvenous placement of left ventricular lead	CS lead will be placed transvenously

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