Imaging Study of Allocation of Pacing Targets in Cardiac Resynchronization Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2023-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Systolic Heart Failure Dysynchrony Image Guidance Digital Twins Cardiac Resynchronization Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

4 dimensional cardiac model to guide optimal delivery of left and right ventricular pacing leads in patients referred for cardiac resynchronization therapy.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Image guided delivery of pacing leads

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

Group Type ACTIVE_COMPARATOR

4D Model guided delivery of cardiac pacing leads

Intervention Type PROCEDURE

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

Standard LV and RV lead placement

Group Type PLACEBO_COMPARATOR

Standard CRT lead delivery

Intervention Type PROCEDURE

Standard lead delivery

Interventions

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4D 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

Intervention Type PROCEDURE

Standard CRT lead delivery

Standard lead delivery

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No