Mechanistic Clinical Trial of Advanced Imaging for CRT
Recruiting · NCT03398369 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Virginia
View the official record on ClinicalTrials.gov →Interventions studied
CMR/CTA Guidance for CRT
What this trial is about
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.
Who can take part
Age range
20 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- University of Virginia Health System - Charlottesville, Virginia, United States