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

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Other: Imaging guided optimal LV lead placement

• Registration Number: NCT01323686
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-03-25
• Study First Submitted QC: 2011-03-25
• Study First Posted: 2011-03-28
• Study Start: 2011-04
• Status Verified: 2013-08
• Primary Completion: 2014-04
• Study Completion: 2014-09
• Last Update Submitted: 2014-09-04
• Last Update Posted: 2014-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Imaging guided LV lead placement	Imaging guided optimal LV lead placement	-

Primary Outcome Measures

Name	Time	Method
Number of participants with clinical response to CRT	6 months after CRT implantation	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.

Secondary Outcome Measures

Name	Time	Method
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	6 months after CRT implantation	Using Minnesota Living with Heart Failure questionnaire.
Changes in Biochemical marker of heart failure	6 months after CRT implantation	Nt-ProBNP
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

Trial Locations

Locations (1)

Department of Cardiology, Aarhus University Hospital, Skejby; 🇩🇰 Aarhus N, Denmark