Advanced Imaging-Guided CRT for Heart Failure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to guide cardiac resynchronization therapy (CRT) for individuals with heart failure. Researchers aim to determine if advanced imaging techniques, such as cardiac magnetic resonance (CMR) and computed tomography angiography (CTA), can enhance CRT outcomes compared to the standard approach. Individuals with heart failure and reduced blood-pumping ability who meet specific CRT guidelines may qualify for this study. Participants will be randomly assigned to receive either standard CRT or the new imaging-guided CRT. As an unphased trial, this study allows participants to contribute to innovative research that could improve heart failure treatments.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this imaging-guided CRT procedure is safe for heart failure patients?
Studies have shown that cardiovascular magnetic resonance (CMR) and computed tomography angiography (CTA) safely capture images of the heart. Research indicates that CMR effectively detects heart problems and aids doctors in treatment decisions. Patients generally tolerate it well, with no major safety issues reported.
One study examined both CMR and CTA for heart disease, finding these imaging methods useful for understanding heart conditions. No serious side effects were reported, making them reliable options for guiding heart treatments.
These findings suggest that using CMR and CTA to guide cardiac resynchronization therapy (CRT) is likely safe. No evidence of major risks exists, making these imaging methods a promising choice for guiding heart procedures.12345Why are researchers excited about this trial?
Researchers are excited about the imaging-guided CRT technique for heart failure because it uses advanced imaging methods like CMR (Cardiac Magnetic Resonance) and CTA (Computed Tomography Angiography) to precisely guide cardiac resynchronization therapy. Unlike standard CRT, which relies on general placement of leads, this approach allows for more accurate targeting of the heart's dysfunctional areas. This precision could potentially enhance the effectiveness of the therapy, improve heart function, and lead to better outcomes for patients with heart failure.
What evidence suggests that CMR/CTA guidance is effective for heart failure?
This trial will compare standard CRT with CMR-guided CRT. Research has shown that advanced imaging methods like CMR (cardiac magnetic resonance) and CTA (computed tomography angiography) can enhance the effectiveness of CRT (cardiac resynchronization therapy) for treating heart failure. One study found that image-guided CRT helps doctors place the device more accurately in the heart, improving heart function. Another study showed that patients with severe heart failure experienced significant benefits from CMR-guided procedures. These imaging techniques enable doctors to plan and perform CRT more precisely, potentially leading to better outcomes for patients with heart failure.45678
Who Is on the Research Team?
Kenneth Bilchick, MD
Principal Investigator
University of Virginia Health System
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Patients undergo CMR, CTA, echocardiography, blood testing, cardiopulmonary exercise testing, and complete a heart failure questionnaire
Treatment
Patients receive CRT with either standard procedure or CMR-guided LV lead placement
Follow-up
Participants are monitored for safety and effectiveness after treatment with assessments at 6 and 12 months
Long-term Follow-up
Clinical follow-up for survival free of appropriate ICD therapies over 3 years
What Are the Treatments Tested in This Trial?
Interventions
- CMR/CTA Guidance for CRT
CMR/CTA Guidance for CRT is already approved in European Union, United States for the following indications:
- Heart failure with reduced ejection fraction (HFrEF)
- Left bundle branch block (LBBB)
- QRS duration ≥150 ms
- Symptomatic heart failure with reduced ejection fraction (HFrEF)
- Left bundle branch block (LBBB)
- QRS duration ≥150 ms
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Virginia
Lead Sponsor