Cardiac Resynchronization Therapy, Digital Twins, Dysynchrony, Image Guidance, Systolic Heart Failure
Conditions
Keywords
Cardiomyopathy, Cardiac Resynchronization Therapy, Image guided therapy, Digital twins, Cardiac Magnetic Resonance Imaging, MRI
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURE4D Model guided delivery of cardiac pacing leads
4D model-guided placement of LV and RV leads to optimal myocardial targets, as derived from pre-procedural Cardiac MRI
PROCEDUREStandard CRT lead delivery
Standard lead delivery
Sponsors
Heart and Stroke Foundation of Canada
Libin Cardiovascular Institute of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
4 dimensional cardiac model to guide optimal delivery of left and right ventricular pacing leads in patients referred for cardiac resynchronization therapy.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years. 2. Ejection fraction ≤ 35 %. 3. LBBB with QRS duration ≥ 120 msec. 4. NYHA class II-IV. 5. On maximum tolerated heart failure medication therapy ≥ 6 weeks. 6. Clinically accepted for CRT device implantation.
Exclusion criteria
1. Failure to provide consent. 2. CCS class III-IV angina. 3. Recent Q-wave myocardial infarction or revascularization procedure ( ≤ 3 months). 4. Atrial fibrillation at time of randomization \>6 weeks in duration 5. Standard contra-indications to MRI. 6. Documented severe allergy to intravenous contrast dye ( iodinated CT contrast or Gadolinium MRI contrast). 7. Estimated Glomerular Filtration Rate (eGFR) ≤ 45 ml/min/m2. 8. Patient is pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determination of response to image guided placement of cardiac ventricular pacing leads in cardiac resynchronization therapy (CRT) | 6 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart failure hospital admissions | 12 months | — |
| improvement in 6-minute hall walk ≥ 30 meters or ≥ 10% | 6 months | 6 minute hallwalk will be done at baseline, 3 months and 6 months |
| Improvement in New York Heart Association (NYHA) functional class by ≥ 1 | 6 months | NYHA class will be determined at baseline, 3 months and 6 months (score out of 4) |
| Improvement in Quality of Life (QOL) score by ≥ 10 points | 6 months | A Minnesota Living with Heart Failure questionnaire will be administered at baseline, 3 months and 6 months (visual analogue score out of 100) |
| All-cause mortality | 12 months | — |
| Total procedural time | 6 month | Total procedural time from first needle to skin closure, in minutes |
| Fluoroscopy dose and exposure time | 6 month | Total fluoroscopy exposure time and radiation dose will be recorded at end of procedure and recorded (in minutes). |
| Procedural complications | 6 months | All procedural complications will be recorded following completion of procedure and at 3 and 6 months. |
| Device complications | 6 months | All device-related complications, inclusive of need for lead repositioning, will be recorded at 3 months and 6 months. |
| Rate of concordant lead delivery to the optimal myocardial target | 6 month | 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. |
Countries
Canada
Outcome results
None listed