Clinical trial NCT01323686: Empiric Versus Imaging Guided Left Ventricular Lead Placement in Cardiac Resynchronization Therapy
Official title: Empiric Versus Imaging Guided Left Ventricular Lead Placement in Cardiac Resynchronization Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2011-03-28
Enrollment: 182
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with clinical response to CRT
timeFrame: 6 months after CRT implantation
Secondary outcomes:
measure: All cause mortality
timeFrame: 6 months after CRT implantation
measure: Hospitalization for heart failure
timeFrame: 6 months after CRT implantation
measure: Changes in NYHA functional class
timeFrame: 6 months after CRT implantation
measure: Changes in 6-Minutes Hall Walk
timeFrame: 6 months after CRT implantation
measure: Changes in Quality of Life
timeFrame: 6 months after CRT implantation
measure: Changes in Biochemical marker of heart failure
timeFrame: 6 months after CRT implantation
measure: Changes in LV Ejection Fraction
timeFrame: 6 months after CRT implantation
measure: Changes of LV end-diastolic volume
timeFrame: 6 months after CRT implantation
measure: Changes of LV end-systolic volume
timeFrame: 6 months after CRT implantation
measure: Changes of LV dyssynchrony
timeFrame: 6 months after CRT implantation
measure: Changes of mitral regurgitation grade
timeFrame: 6 months after CRT implantation
measure: Duration of CRT implantation
timeFrame: During CRT implantation
measure: Complications
timeFrame: 6 months after CRT implantation
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Department of Cardiology, Aarhus University Hospital, Skejby
Study officials:
affiliation: Aarhus University Hospital
name: Jens C. Nielsen, Professor, PhD, DMSc
role: STUDY_CHAIR
affiliation: Aarhus University Hospital
name: Anders Sommer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.