Advanced Imaging-Guided CRT for Heart Failure

Overseen By Kenneth C Bilchick, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Virginia

Disqualifiers: Pregnancy, Kidney disease, Liver transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Ongoing

180 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a mechanistic clinical trial with randomization to guidance for the CRT procedure using cardiac magnetic resonance (CMR) and computed tomography angiography (CTA) versus a standard procedure.

Research Team

Kenneth Bilchick, MD

Principal Investigator

University of Virginia Health System

Eligibility Criteria

This trial is for individuals with chronic systolic heart failure, having a left ventricular ejection fraction (LVEF) of 35% or less, and who meet the criteria for Cardiac Resynchronization Therapy (CRT). Participants must be able to consent. Those with metal in their body, severe claustrophobia, kidney issues, liver transplant, gadolinium allergy or significant irregular heartbeat are excluded.

Inclusion Criteria

I have chronic heart failure with reduced ejection fraction.

Your heart's pumping ability is very weak, at 35% or less.

My condition is recommended for cardiac resynchronization therapy.

Exclusion Criteria

You have cerebral aneurysm clips.

Criterion: You have a cochlear implant.

Inability to provide informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Patients undergo CMR, CTA, echocardiography, blood testing, cardiopulmonary exercise testing, and complete a heart failure questionnaire

1-2 weeks

Treatment

Patients receive CRT with either standard procedure or CMR-guided LV lead placement

Ongoing

Follow-up

Participants are monitored for safety and effectiveness after treatment with assessments at 6 and 12 months

12 months

Long-term Follow-up

Clinical follow-up for survival free of appropriate ICD therapies over 3 years

3 years

Treatment Details

Interventions

• CMR/CTA Guidance for CRT

Trial Overview The study compares CRT guidance using advanced imaging techniques like cardiac magnetic resonance (CMR) and computed tomography angiography (CTA), against standard CRT procedures. Patients will be randomly assigned to either the CMR/CTA-guided group or the standard procedure group.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

CMR-Guided CRT

Group II: Control Active Control 1 Intervention

Standard CRT

CMR/CTA Guidance for CRT is already approved in European Union, United States for the following indications:

Approved in European Union as CMR/CTA Guidance for CRT for:

• Heart failure with reduced ejection fraction (HFrEF)
• Left bundle branch block (LBBB)
• QRS duration ≥150 ms

Approved in United States as CMR/CTA Guidance for CRT for:

• Symptomatic heart failure with reduced ejection fraction (HFrEF)
• Left bundle branch block (LBBB)
• QRS duration ≥150 ms

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+