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Mechanistic Clinical Trial of Advanced Imaging for CRT

RECRUITINGN/ASponsored by University of Virginia
Actively Recruiting
PhaseN/A
SponsorUniversity of Virginia
Started2018-01-05
Est. completion2025-01-15
Eligibility
Age20 Years – 90 Years
Healthy vol.Accepted
Locations1 site

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.

Eligibility

Age: 20 Years – 90 YearsHealthy volunteers accepted
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.

Conditions2

Heart DiseaseHeart Failure Systolic

Locations1 site

University of Virginia Health System
Charlottesville, Virginia, 22908
John Hoover434-243-4861jrh5r@hscmail.mcc.virginia.edu

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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