Imaging-guided CRT using MRI and CT to personalize device placement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial compares a cardiac imaging-guided CRT procedure using magnetic resonance imaging and CT angiography to a standard CRT approach. Participants undergo baseline imaging and testing, including CMR, CTA, echocardiography, blood work, exercise testing, and a heart failure questionnaire. In the MRI-guided arm, the left ventricular lead is placed using MRI data on scar, activation, and anatomy, with follow-ups at 6 and 12 months and longer-term survival monitoring for three years. The study is conducted at the University of Virginia Health System and is overseen by UVA as lead sponsor.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Chronic systolic HF
2. LVEF 35% or less
3. Guideline-based class I or II indication for CRT

Exclusion Criteria:

1. Inability to provide informed consent
2. Pregnancy
3. Presence of metal embedded in the body due to prior accident or injury, as documented by skull films or other imaging
4. Cerebral aneurysm clips
5. Cochlear implants
6. Other metallic implants known to be contraindications to CMR (does not include pacemakers and ICDs)
7. Severe claustrophobia
8. Acute kidney injury
9. Acute renal failure or chronic kidney disease with GFR \< 45 cc/min/1.73m2
10. Liver transplant
11. Gadolinium allergy
12. \>10% premature ventricular contraction (PVC) burden; and 13) estimated \>10% atrial fibrillation (AF) burden based on available clinical data.

Where it's running

• University of Virginia Health System
  Charlottesville, Virginia, United States Recruiting

Study contacts

• Principal investigator: Kenneth C Bilchick, MD — University of Virginia Health System
• Study coordinator: Kenneth C Bilchick, MD
• Email: bilchick@virginia.edu
• Phone: 4349242465

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.