Comparison of Epicardial Versus Conventional Lead Placement in Cardiac Resynchronization Therapy

NCT ID: NCT01302470

Last Updated: 2015-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2012-03-31

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.

Conditions

Cardiac Resynchronization Therapy; Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Robotic placement of CS lead

CS leads placed epicardially in the area of increased dyssynchrony as demonstrated by low dose dobutamine stress testing.

Group Type: ACTIVE_COMPARATOR

Primary epicardial placement of left ventricular lead

Intervention Type: PROCEDURE

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

Transvenous placement of CS lead

CS lead will be placed transvenously

Group Type: ACTIVE_COMPARATOR

Transvenous placement of left ventricular lead

Intervention Type: PROCEDURE

Conventional placement of left ventricular leads performed in the electrophysiology department.

Interventions

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

Intervention Type: PROCEDURE

Transvenous placement of left ventricular lead

Conventional placement of left ventricular leads performed in the electrophysiology department.

Intervention Type: PROCEDURE

Other Intervention Names

cardiac resynchronization therapy; Cardiac resynchronization Therapy; CRT/ AICD

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Montefiore Medical Center

OTHER

Sponsor Role: collaborator

St. Luke's-Roosevelt Hospital Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

St.Lukes-Roosevelt Hospital

New York, New York, United States

Countries

United States

Other Identifiers

04-052

Identifier Type: -

Identifier Source: org_study_id