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

Study Overview
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Brief Summary
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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.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Imaging guided optimal LV lead placement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Imaging guided LV lead placement<br> | Other: Imaging guided optimal LV lead placement<br>* 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.<br>|
| No Intervention: Empiric LV lead placement<br>LV lead placement using standard clinical routine. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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: Death from any cause. Hospitalization for heart failure. No improvement in New York Heart Association (NYHA) functional class and <10% improvement in 6-minutes hall walk at end of study period. | 6 months after CRT implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | 6 months after CRT implantation | 
| Hospitalization for heart failure |  | 6 months after CRT implantation | 
| Changes in NYHA functional class |  | 6 months after CRT implantation | 
| Changes in 6-Minutes Hall Walk |  | 6 months after CRT implantation | 
| Changes in Quality of Life | Using Minnesota Living with Heart Failure questionnaire. | 6 months after CRT implantation | 
| Changes in Biochemical marker of heart failure | Nt-ProBNP | 6 months after CRT implantation | 
| Changes in LV Ejection Fraction |  | 6 months after CRT implantation | 
| Changes of LV end-diastolic volume |  | 6 months after CRT implantation | 
| Changes of LV end-systolic volume |  | 6 months after CRT implantation | 
| Changes of LV dyssynchrony |  | 6 months after CRT implantation | 
| Changes of mitral regurgitation grade |  | 6 months after CRT implantation | 
| Duration of CRT implantation |  | During CRT implantation | 
| Complications |  | 6 months after CRT implantation |