Status:
UNKNOWN
Mechanistic Clinical Trial of Advanced Imaging for CRT
Lead Sponsor:
University of Virginia
Conditions:
Heart Failure, Systolic
Eligibility:
All Genders
20-90 years
Phase:
NA
Brief 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.
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 gu...
Eligibility Criteria
Inclusion
- Chronic systolic HF
- LVEF 35% or less
- Guideline-based class I or II indication for CRT
Exclusion
- 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.
Key Trial Info
Start Date :
January 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 15 2025
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT03398369
Start Date
January 5 2018
End Date
January 15 2025
Last Update
February 6 2020
Active Locations (1)
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1
University of Virginia Health System
Charlottesville, Virginia, United States, 22908