Mechanistic Clinical Trial of Advanced Imaging for CRT
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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 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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Intervention CMR-Guided CRT |
Diagnostic Test: 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.
|
No Intervention: Control Standard CRT |
Outcome Measures
Primary Outcome Measures
- Left ventricular end-systolic volume (LVESV) improvement [One Year]
Change in LVESV with cardiac resynchronization therapy (CRT)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Chronic systolic HF
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LVEF 35% or less
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Guideline-based class I or II indication for CRT
Exclusion Criteria:
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Inability to provide informed consent
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Pregnancy
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Presence of metal embedded in the body due to prior accident or injury, as documented by skull films or other imaging
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Cerebral aneurysm clips
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Cochlear implants
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Other metallic implants known to be contraindications to CMR (does not include pacemakers and ICDs)
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Severe claustrophobia
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Acute kidney injury
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Acute renal failure or chronic kidney disease with GFR < 45 cc/min/1.73m2
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Liver transplant
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Gadolinium allergy
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10% premature ventricular contraction (PVC) burden; and 13) estimated >10% atrial fibrillation (AF) burden based on available clinical data.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Virginia Health System | Charlottesville | Virginia | United States | 22908 |
Sponsors and Collaborators
- University of Virginia
Investigators
- Principal Investigator: Kenneth C Bilchick, MD, University of Virginia Health System
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UVAMRICRTTRIAL