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

Heart Failure Clinical Trial

— ImagingCRT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01323686
• Other study ID #: sksCRT
• Status: Completed
• Phase: N/A
• First received: March 25, 2011
• Last updated: September 4, 2014
• Start date: April 2011
• Est. completion date: September 2014

Study information

• Verified date: August 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: September 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Denmark	Department of Cardiology, Aarhus University Hospital, Skejby	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	All cause mortality		6 months after CRT implantation	No
Secondary	Hospitalization for heart failure		6 months after CRT implantation	No
Secondary	Changes in NYHA functional class		6 months after CRT implantation	No
Secondary	Changes in 6-Minutes Hall Walk		6 months after CRT implantation	No
Secondary	Changes in Quality of Life	Using Minnesota Living with Heart Failure questionnaire.	6 months after CRT implantation	No
Secondary	Changes in Biochemical marker of heart failure	Nt-ProBNP	6 months after CRT implantation	No
Secondary	Changes in LV Ejection Fraction		6 months after CRT implantation	No
Secondary	Changes of LV end-diastolic volume		6 months after CRT implantation	No
Secondary	Changes of LV end-systolic volume		6 months after CRT implantation	No
Secondary	Changes of LV dyssynchrony		6 months after CRT implantation	No
Secondary	Changes of mitral regurgitation grade		6 months after CRT implantation	No
Secondary	Duration of CRT implantation		During CRT implantation	No
Secondary	Complications		6 months after CRT implantation	No