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| Name | Class |
|---|---|
| Heart and Stroke Foundation of Canada | OTHER |
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This randomized controlled trial will assess a cardiac MRI derived 4D digital cardiac model to optimized left and right ventricular lead delivery to improve response to cardiac resynchronization therapy.
Regional mechanical delay, myocardial scar, and inter-lead distance have each been demonstrated to be relevant variables for the realization of optimal response to cardiac resynchronization therapy (CRT). Pilot study results have suggested clinical feasibility and potential value from LV and RV lead navigation aimed at optimizing these combined variables. A computer software program has been developed to deliver an interactive, 4D digital heart model of mechanical dyssynchrony and myocardial scar to guide LV and RV CRT lead delivery to optimal targets. This multi-center randomized clinical trial has been designed to assess the feasibility, safety and clinical impact of LV-RV lead navigation using a web-deployed 4D cardiac model.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Image guided delivery of pacing leads | Active Comparator | 4D model-guided placement of LV and RV leads to optimal myocardial targets, as derived from pre-procedural Cardiac MRI |
|
| Standard delivery of pacing leads | Placebo Comparator | Standard LV and RV lead placement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4D Model guided delivery of cardiac pacing leads | Procedure | 4D model-guided placement of LV and RV leads to optimal myocardial targets, as derived from pre-procedural Cardiac MRI |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of response to image guided placement of cardiac ventricular pacing leads in cardiac resynchronization therapy (CRT) | Cardiac Resynchronization Therapy (CRT) response will be defined as a change in the Left Ventricular Ejection Fraction measured at 6 months post CRT device implant by MUGA (multigated acquisition scan / wall motion study). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | 12 months | |
| Heart failure hospital admissions | 12 months | |
| improvement in 6-minute hall walk ≥ 30 meters or ≥ 10% |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James White, MD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Conect Research, University of Calgary | Calgary | Alberta | T2N 4Z6 | Canada | ||
| Halifax Capital Districy Health Authority |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41446931 | Derived | Chew DS, Vandenberk B, Exner DV, Labib D, Flewitt J, Mikami Y, Rivest S, Chan D, Manlucu J, Leong-Sit P, Rinne C, Birnie DH, Nery PB, Sumner G, Ayala-Paredes F, Philippon F, Yee R, White JA. 4D Digital Heart Model-Guided Left and Right Ventricular Lead Placement for Cardiac Resynchronization Therapy: Results of MAPIT-CRT Trial. Circ Arrhythm Electrophysiol. 2026 Jan;19(1):e014132. doi: 10.1161/CIRCEP.125.014132. Epub 2025 Dec 25. | |
| 25221334 |
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4 dimensional cardiac model to guide optimal delivery of left and right ventricular pacing leads in patients referred for cardiac resynchronization therapy.
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| Standard CRT lead delivery | Procedure | Standard lead delivery |
|
6 minute hallwalk will be done at baseline, 3 months and 6 months |
| 6 months |
| Improvement in New York Heart Association (NYHA) functional class by ≥ 1 | NYHA class will be determined at baseline, 3 months and 6 months (score out of 4) | 6 months |
| Improvement in Quality of Life (QOL) score by ≥ 10 points | A "Minnesota Living with Heart Failure" questionnaire will be administered at baseline, 3 months and 6 months (visual analogue score out of 100) | 6 months |
| Rate of concordant lead delivery to the "optimal myocardial target" | On the day of procedure, a post lead implant bi-plane fluoroscopy image and PA-LAT CXR will be obtained. These will be reviewed by a core laboratory to score final lead tip (electrode) location using a standardized report form to determine delivery location based on the AHA segmental model. | 6 month |
| Total procedural time | Total procedural time from first needle to skin closure, in minutes | 6 month |
| Fluoroscopy dose and exposure time | Total fluoroscopy exposure time and radiation dose will be recorded at end of procedure and recorded (in minutes). | 6 month |
| Procedural complications | All procedural complications will be recorded following completion of procedure and at 3 and 6 months. | 6 months |
| Device complications | All device-related complications, inclusive of need for lead repositioning, will be recorded at 3 months and 6 months. | 6 months |
| Halifax |
| Nova Scotia |
| B3H3A7 |
| Canada |
| Libin Cardiovascular Institute | London | Ontario | N6A5A5 | Canada |
| Ottawa Heart Institute Research Corporation | Ottawa | Ontario | K1Y4W7 | Canada |
| University of Laval Research Centre | Québec | Quebec | G1V 4G5 | Canada |
| Derived |
| Laksman Z, Yee R, Stirrat J, Gula LJ, Skanes AC, Leong-Sit P, Manlucu J, McCarty D, Turkistani Y, Scholl D, Rajchl M, Goela A, Islam A, Thompson RT, Drangova M, White JA. Model-based navigation of left and right ventricular leads to optimal targets for cardiac resynchronization therapy: a single-center feasibility study. Circ Arrhythm Electrophysiol. 2014 Dec;7(6):1040-7. doi: 10.1161/CIRCEP.114.001729. Epub 2014 Sep 14. |
| ID | Term |
|---|---|
| D054143 | Heart Failure, Systolic |
| D009202 | Cardiomyopathies |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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