Imaging Study of Allocation of Pacing Targets in Cardiac Resynchronization Therapy

Libin Cardiovascular Institute of Alberta

Status: Completed

Conditions: Systolic Heart Failure; Cardiac Resynchronization Therapy; Image Guidance; Dysynchrony; Digital Twins

Treatments: Procedure: Standard CRT lead delivery; Procedure: 4D Model guided delivery of cardiac pacing leads

Study type: Interventional

Funder types: Other

Identifiers

NCT01640769

MAPIT-CRT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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210 participants in 2 patient groups, including a placebo group

Image guided delivery of pacing leads

Active Comparator group

Description:

4D model-guided placement of LV and RV leads to optimal myocardial targets, as derived from pre-procedural Cardiac MRI

Treatment:

Procedure: 4D Model guided delivery of cardiac pacing leads

Standard delivery of pacing leads

Placebo Comparator group

Description:

Standard LV and RV lead placement

Treatment:

Procedure: Standard CRT lead delivery