Mechanistic Clinical Trial of Advanced Imaging for CRT

Overview

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.

Full Title of Study: “Advanced Imaging and Inflammatory Markers to Define Mechanisms of Response to CRT”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: January 15, 2025

Detailed Description

At baseline, patients will have CMR, CTA, echocardiography, blood testing, and cardiopulmonary exercise testing. They will also complete a heart failure questionnaire. In patients randomized to CMR guidance for the CRT procedure, LV lead placement will be guided by the MRI information related to scar, activation and anatomy. Patients will have follow-up assessments at 6 and 12 months. There will also be clinical follow-up for survival free of appropriate ICD therapies over 3 years.

Interventions

  • Diagnostic Test: CMR/CTA Guidance for CRT
    • The intervention is the use of CMR and CTA to determine the optimal pacing site in the left ventricle for cardiac resynchronization therapy (CRT) and guide left ventricular lead placement.

Arms, Groups and Cohorts

  • Experimental: Intervention
    • CMR-Guided CRT
  • No Intervention: Control
    • Standard CRT

Clinical Trial Outcome Measures

Primary Measures

  • Left ventricular end-systolic volume (LVESV) improvement
    • Time Frame: One Year
    • Change in LVESV with cardiac resynchronization therapy (CRT)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Virginia
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kenneth Bilchick, MD, Associate Professor of Medicine – University of Virginia
  • Overall Official(s)
    • Kenneth C Bilchick, MD, Principal Investigator, University of Virginia Health System
  • Overall Contact(s)
    • Kenneth C Bilchick, MD, 4349242465, bilchick@virginia.edu

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