Mechanistic Clinical Trial of Advanced Imaging for CRT

  • STATUS
    Recruiting
  • End date
    Jan 15, 2025
  • participants needed
    180
  • sponsor
    University of Virginia
Updated on 26 February 2022
angiography
MRI

Summary

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.

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.

Details
Condition Heart Failure, Systolic
Treatment MRI-Guided CRT, CMR/CTA Guidance for CRT
Clinical Study IdentifierNCT03398369
SponsorUniversity of Virginia
Last Modified on26 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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