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| ID | Type | Description | Link |
|---|---|---|---|
| 404460098327 | Other Grant/Funding Number | ZonMW | |
| LSHM191o3-Ho7o | Other Grant/Funding Number | Health-Holland |
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| Name | Class |
|---|---|
| CART-Tech B.V. | UNKNOWN |
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
| Health Holland | OTHER |
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Cardiac resynchronization therapy (CRT) is an established pacemaker therapy for patients with symptomatic chronic heart failure, but is hampered by a non-response rate of 30-40%. Optimising left ventricular (LV) lead placement is the cornerstone of improving treatment. The optimal location for the lead is remote from scar but within segments demonstrating late electromechanical activation. The present study aims to investigate the efficacy and clinical effect of the use of real-time guided lead placement using cardiac MRI and fluoroscopy in a blinded, multicenter, randomized controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Live visualised, fluoroscopy-fused, image-guided, left ventricular lead placement on the basis of avoiding scar and targeting late mechanically activated segments. |
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| Control group | No Intervention | Empirical standard-of-care left ventricular lead placement, in line with current CRT implantation guidelines with electrical guiding on the basis of Q-LV sense. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CARTBox | Device | CARTBox performs analysis of cardiac MRI scans. The result is a treatment file that displays optimal targets for left ventricular lead implantation in CRT. This file will be used as an overlay with live fluoroscopy during the implantation procedure in the intervention group. |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in % of patients with succesfull LV lead location | Lead location, defined as being within, adjacent, or remote from the pre-defined target. | Direct post-CRT |
| Measure | Description | Time Frame |
|---|---|---|
| Change in reverse remodelling and volumetric response | Measured as the relative decrease in LV end-systolic volume, indexed to body surface area (LVESVi). Response defined as LVESVi-reduction ≥ 15%. | 6 months |
| Change in EQ-5D-5L |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in total implantation procedure time. | Compared between both groups. Measured in minutes. | Direct post-CRT |
| Difference in total fluoroscopy time during procedure. | Compared between both groups. Measured in minutes. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mathias Meine, MD, PhD | UMC Utrecht | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus MC | Rotterdam | South Holland | 3015 GD | Netherlands | ||
| Amsterdam UMC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36713038 | Background | Wouters PC, van Slochteren FJ, Tuinenburg AE, Doevendans PA, Cramer MM, Delnoy PHM, van Dijk VF, Meine M. On-screen image-guided lead placement in cardiac resynchronization therapy: Feasibility and outcome in a multicenter setting. Heart Rhythm O2. 2022 Oct 18;4(1):9-17. doi: 10.1016/j.hroo.2022.10.002. eCollection 2023 Jan. | |
| 34697125 |
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Within legal and ethical limits, deidentified individual clinical trial participant-level data (IPD), generated by our research, can be made available. Upon publication, data will be made available upon reasonable request and in agreement with a collaboration agreement. A data sharing and management plan is provided.
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
A quality of life questionnaire
| 6, 12 and 24 months |
| Change in Kansas City Cardiomyopathy Questionnaire | A quality of life questionnaire | 6, 12 and 24 months |
| Change in CRT response score | A hierarchical clinical endpoints, combining relative LVESVi-decrease, change in New York Heart Association class, and death at 12 month follow-up. | 12 months |
| Health Technology Assessment | The value of image-guided lead placement will be investigated in terms of healthcare expenditure revolving heart failure care. This assesment will be based on a previously conducted preliminary economic analysis. | 24 months |
| Direct post-CRT |
| Difference in total contrast dose used during procedure. | Compared between both groups. Measured in dose area product. | Direct post-CRT |
| Difference in change in QRS duration | Compared between groups and according to LV lead location. Measured in ms. | Direct post-CRT and 6 months |
| Difference in change in QRSarea | Compared between groups and according to LV lead location. Measured in μVs. | Direct post-CRT and 6 months |
| Difference in Q-LV sense | Compared between groups and according to LV lead location. Measured in ms. | Direct post-CRT |
| Difference in pacing threshold | Compared between groups and according to LV lead location. Measured in mV. | Direct post-CRT |
| Difference in % of patients with disappearance of apical rocking | Compared between groups and according to LV lead location. Option to assess other indices of mechanical recoordination. | Direct post-CRT and 6 months |
| Amsterdam |
| Netherlands |
| UMC Groningen | Groningen | Netherlands |
| Maastricht UMC+ | Maastricht | Netherlands |
| St. Antonius Nieuwegein | Nieuwegein | Netherlands |
| UMC Utrecht | Utrecht | Netherlands |
| Isala Zwolle | Zwolle | Netherlands |
| Wouters PC, van Lieshout C, van Dijk VF, Delnoy PH, Doevendans PA, Cramer MJ, Frederix GW, van Slochteren FJ, Meine M. Advanced image-supported lead placement in cardiac resynchronisation therapy: protocol for the multicentre, randomised controlled ADVISE trial and early economic evaluation. BMJ Open. 2021 Oct 25;11(10):e054115. doi: 10.1136/bmjopen-2021-054115. |
| 40117420 | Result | Gerrits W, Wouters PC, Chiu CSL, Guglielmo M, Cramer MJ, van der Harst P, Vernooy K, van Stipdonk AMW, van Halm VP, van Dijk VF, Ghani A, Maass AH, Yap SC, van Slochteren FJ, Meine M. Optimizing CRT Lead Placement Accuracy With CMR-Guided On-Screen Targeting: A Randomized Controlled Trial (ADVISE-CRT III). JACC Clin Electrophysiol. 2025 Jun;11(6):1293-1305. doi: 10.1016/j.jacep.2025.01.022. Epub 2025 Mar 19. |