Heart Failure
Conditions
Keywords
Cardiac Resynchronization Therapy, Image-guided therapy, Lead placement, MRI
Brief summary
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.
Interventions
DEVICECARTBox
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.
Sponsors
CART-Tech B.V.
ZonMw: The Netherlands Organisation for Health Research and Development
Health Holland
UMC Utrecht
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Heart failure with LV ejection fraction ≤ 35%; * New York Heart Association class II, III, or IV (ambulatory); * Optimal medical treatment that is tolerable; * Left bundle branch block (LBBB) and QRS ≥ 130 ms, OR non-LBBB and QRS ≥ 150 ms.
Exclusion criteria
* Pregnancy or lactation; * Subjects with impaired renal function (severe renal insufficiency, GFR \< 30 ml/min/1.73m2); * Atrial fibrillation or atrial fibrillation during MRI * Documented allergic reaction to gadolinium; * Impossibility to undergo an MRI scan; * Participation in another clinical study that prohibits any procedures other than standard.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in % of patients with succesfull LV lead location | Direct post-CRT | Lead location, defined as being within, adjacent, or remote from the pre-defined target. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in reverse remodelling and volumetric response | 6 months | Measured as the relative decrease in LV end-systolic volume, indexed to body surface area (LVESVi). Response defined as LVESVi-reduction ≥ 15%. |
| Change in EQ-5D-5L | 6, 12 and 24 months | A quality of life questionnaire |
| Change in Kansas City Cardiomyopathy Questionnaire | 6, 12 and 24 months | A quality of life questionnaire |
| Change in CRT response score | 12 months | A hierarchical clinical endpoints, combining relative LVESVi-decrease, change in New York Heart Association class, and death at 12 month follow-up. |
| Health Technology Assessment | 24 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Difference in pacing threshold | Direct post-CRT | Compared between groups and according to LV lead location. Measured in mV. |
| Difference in total implantation procedure time. | Direct post-CRT | Compared between both groups. Measured in minutes. |
| Difference in % of patients with disappearance of apical rocking | Direct post-CRT and 6 months | Compared between groups and according to LV lead location. Option to assess other indices of mechanical recoordination. |
| Difference in total fluoroscopy time during procedure. | Direct post-CRT | Compared between both groups. Measured in minutes. |
| Difference in total contrast dose used during procedure. | Direct post-CRT | Compared between both groups. Measured in dose area product. |
| Difference in change in QRS duration | Direct post-CRT and 6 months | Compared between groups and according to LV lead location. Measured in ms. |
| Difference in change in QRSarea | Direct post-CRT and 6 months | Compared between groups and according to LV lead location. Measured in μVs. |
| Difference in Q-LV sense | Direct post-CRT | Compared between groups and according to LV lead location. Measured in ms. |
Countries
Netherlands
Outcome results
None listed