Mechanistic Clinical Trial of Advanced Imaging for CRT
Purpose
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
- Heart Failure, Systolic
Eligibility
- Eligible Ages
- Between 20 Years and 90 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Chronic systolic HF 2. LVEF 35% or less 3. Guideline-based class I or II indication for CRT
Exclusion Criteria
- 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Intervention |
CMR-Guided CRT |
|
|
No Intervention Control |
Standard CRT |
|
Recruiting Locations
University of Virginia Health System
Charlottesville, Virginia 22908
Charlottesville, Virginia 22908
More Details
- Status
- Recruiting
- Sponsor
- University of Virginia
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.