Mechanistic Clinical Trial of Advanced Imaging for CRT

RECRUITING

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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.

Conditions:

🦠 Heart Failure, Systolic

🗓️ Study Start (Actual) 5 January 2018

🗓️ Primary Completion (Estimated) 15 January 2025

✅ Study Completion (Estimated) 15 January 2025

👥 Enrollment (Estimated) 180

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 Charlottesville, Virginia, United States

📋 Eligibility Criteria

Description

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.

Ages Eligible for Study: 20 Years to 90 Years (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 7 January 2018
First Submitted that Met QC Criteria 7 January 2018
First Posted 12 January 2018

Study Record Updates

Last Update Submitted that Met QC Criteria 4 February 2020
Last Update Posted 6 February 2020
Last Verified February 2020