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NCT03398369NARecruiting

Mechanistic Clinical Trial of Advanced Imaging for CRT

University of Virginia

Start Date

1/5/2018

Completion Date

1/15/2025

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 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.

Eligibility Criteria

Age Range: 20 years to 90 years

Inclusion Criteria: 1. Chronic systolic HF 2. LVEF 35% or less 3. Guideline-based class I or II indication for CRT Exclusion Criteria: 1. 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.

Interventions

DIAGNOSTIC_TEST

CMR/CTA Guidance for CRT

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Conditions

Heart Failure, Systolic

Locations

University of Virginia Health System

Charlottesville, Virginia 22908

United States