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

  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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

University of Virginia Health System
Charlottesville, Virginia 22908
Contact:
John Hoover
434-243-4861
jrh5r@hscmail.mcc.virginia.edu

More Details

Status
Recruiting
Sponsor
University of Virginia

Study Contact

Kenneth C Bilchick, MD
4349242465
bilchick@virginia.edu

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.