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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imaging guided LV lead placement | Experimental |
| |
| Empiric LV lead placement | No Intervention | LV lead placement using standard clinical routine. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imaging guided optimal LV lead placement | Other | 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. |
| 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:
| 6 months after CRT implantation |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens C. Nielsen, Professor, PhD, DMSc | Aarhus University Hospital | Study Chair |
| Anders Sommer, MD | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, Aarhus University Hospital, Skejby | Aarhus N | DK-8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39360929 | Derived | Fyenbo DB, Norgaard BL, Blanke P, Sommer A, Duchscherer J, Kalk K, Kronborg MB, Jensen JM, McVeigh ER, Delgado V, Leipsic J, Nielsen JC. Geometric Changes in Mitral Valve Apparatus during Long-term Cardiac Resynchronization Therapy as Assessed with Cardiac CT. Radiol Cardiothorac Imaging. 2024 Oct;6(5):e230320. doi: 10.1148/ryct.230320. | |
| 23782792 |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| 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 |
| 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. |