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

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 Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: Imaging guided optimal LV lead placement

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus N, Denmark, DK-8200
    • Department of Cardiology, Aarhus University Hospital, Skejby

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Imaging guided LV lead placement	Other: Imaging guided optimal LV lead placement; 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.
No Intervention: Empiric LV lead placement; LV lead placement using standard clinical routine.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Study Chair: Jens C. Nielsen, Professor, PhD, DMSc, Aarhus University Hospital; Principal Investigator: Anders Sommer, MD, Aarhus University Hospital

Publications and helpful links

General Publications

• Sommer A, Kronborg MB, Poulsen SH, Bottcher M, Norgaard BL, Bouchelouche K, Mortensen PT, Gerdes C, Nielsen JC. Empiric versus imaging guided left ventricular lead placement in cardiac resynchronization therapy (ImagingCRT): study protocol for a randomized controlled trial. Trials. 2013 Apr 26;14:113. doi: 10.1186/1745-6215-14-113.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: March 25, 2011
• First Submitted That Met QC Criteria: March 25, 2011
• First Posted (Estimate): March 28, 2011

Study Record Updates

• Last Update Posted (Estimate): September 5, 2014
• Last Update Submitted That Met QC Criteria: September 4, 2014
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: sksCRT