Comparison of Epicardial Versus Conventional Lead Placement in Cardiac Resynchronization Therapy

NCT01302470 | Completed

• 1 other identifier: 04-052
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Resynchronization Therapy; Heart Failure

Keywords

biventricular pacing

Outcome Measures

Primary Outcomes (1)

• CHF Hospitalizations & mortality

  Heart failure and mortality will be assesd along with six minute hall walk tests

  one year post implant.

Study Arms (2)

Robotic placement of CS lead

ACTIVE COMPARATOR

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

Procedure: Primary epicardial placement of left ventricular lead

Transvenous placement of CS lead

ACTIVE COMPARATOR

CS lead will be placed transvenously

Procedure: Transvenous placement of left ventricular lead

Interventions

Primary epicardial placement of left ventricular lead 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

Also known as: cardiac resynchronization therapy

Robotic placement of CS lead

Transvenous placement of left ventricular lead PROCEDURE

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

Also known as: Cardiac resynchronization Therapy, CRT/ AICD

Transvenous placement of CS lead

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• St. Luke's-Roosevelt Hospital Center: lead
• Montefiore Medical Center: collaborator

Study Sites (1)

St.Lukes-Roosevelt Hospital

New York, New York, 10025, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2011
• First Posted: February 24, 2011
• Study Start: February 1, 2005
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: February 19, 2015

Record last verified: 2015-02

Locations

US (1)