Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
180 participants
INTERVENTIONAL
2018-01-05
2025-01-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention
CMR-Guided CRT
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.
Control
Standard CRT
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. LVEF 35% or less
3. Guideline-based class I or II indication for CRT
Exclusion Criteria
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.
20 Years
90 Years
ALL
No
Sponsors
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University of Virginia
OTHER
Responsible Party
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Kenneth Bilchick, MD
Associate Professor of Medicine
Principal Investigators
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Kenneth C Bilchick, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia Health System
Locations
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University of Virginia Health System
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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UVAMRICRTTRIAL
Identifier Type: -
Identifier Source: org_study_id
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