Comparison of Epicardial Versus Conventional Lead Placement in Cardiac Resynchronization Therapy

Study Overview
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Brief Summary
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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
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A secondary goal is to explore the link between efficacy of CRT and inotropic contractile reserve as measured by dobutamine stress echocardiography.

Official Title
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Randomized Study of Endovascular Versus Epicardial Lead Placement for Resynchronization Therapy

Conditions
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Cardiac Resynchronization Therapy, Heart Failure

Intervention / Treatment
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* Procedure: Primary epicardial placement of left ventricular lead
* Procedure: Transvenous placement of left ventricular lead


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Robotic placement of CS lead<br>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<br>* 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<br>* Other names: cardiac resynchronization therapy;|
| Active Comparator: Transvenous placement of CS lead<br>CS lead will be placed transvenously | Procedure: Transvenous placement of left ventricular lead<br>* Conventional placement of left ventricular leads performed in the electrophysiology department.<br>* Other names: CRT/ AICD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CHF Hospitalizations & mortality | Heart failure and mortality will be assesd along with six minute hall walk tests | one year post implant. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biventricular pacing