Empiric Versus Imaging Guided Left Ventricular Lead Placement in Cardiac Resynchronization Therapy

University of Aarhus182 enrolled

Overview

The aim of this study is to investigate if imaging guided optimal left ventricular (LV) lead placement improves the response rate to cardiac resynchronization therapy (CRT). Consecutive patients meeting the standard criteria for CRT are included in a prospective, double-blinded, randomized trial to LV lead positioning either 1) guided by cardiac imaging using echocardiography, single-photon emission computed tomography, and visualization of cardiac venous anatomy (cardiac computed tomography (CT), venography) to target an epicardial vein at the site of latest mechanical activation without scar tissue or 2) using standard LV lead placement.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

182

Conditions

Heart Failure

Interventions

LV lead placement guided by cardiac imaging using echocardiography, single-photon emission computed tomography, and CT to target a cardiac vein at the site of latest mechanical activation without scar tissue. Visualization of cardiac venous anatomy is performed using cardiac CT if not contraindicated by depressed renal function (estimated glomerular filtration rate \<30 ml/min) or allergy to contrast media. In that case, a coronary venogram is used.

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Symptomatic heart failure (New York Heart Association functional class II - IV) despite stabile optimal medical therapy. * ECG with QRS ≥ 120 milliseconds and left bundle branch block (LBBB) or paced QRS ≥ 180 milliseconds. * LV systolic dysfunction (Ejection Fraction ≤ 35%). * written informed consent. Exclusion Criteria: * Expected lifetime \< 6 months. * Recent myocardial infarction (\< 3 months). * Pregnant or lactating. * Inadequate echocardiographic images for determination of site with latest mechanical activation * No written informed consent.

Outcomes

Primary Outcomes

Number of participants with clinical response to CRT

Response to CRT defined as a combination of survival, free of hospitalization for heart failure, and improved functional status. The primary endpoint is attained if the patient is registered for one of the following three events: 1. Death from any cause. 2. Hospitalization for heart failure. 3. No improvement in New York Heart Association (NYHA) functional class and \<10% improvement in 6-minutes hall walk at end of study period.