Mechanistic Clinical Trial of Advanced Imaging for CRT

University of Virginia

Status

Enrolling

Conditions

Heart Failure, Systolic

Treatments

Diagnostic Test: CMR/CTA Guidance for CRT

Study type

Interventional

Funder types

Other

Identifiers

NCT03398369

UVAMRICRTTRIAL

Details and patient eligibility

About

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.

Full 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.

Enrollment

180 estimated patients

Sex

All

Ages

20 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Chronic systolic HF
LVEF 35% or less
Guideline-based class I or II indication for CRT

Exclusion criteria

Inability to provide informed consent
Pregnancy
Presence of metal embedded in the body due to prior accident or injury, as documented by skull films or other imaging
Cerebral aneurysm clips
Cochlear implants
Other metallic implants known to be contraindications to CMR (does not include pacemakers and ICDs)
Severe claustrophobia
Acute kidney injury
Acute renal failure or chronic kidney disease with GFR < 45 cc/min/1.73m2
Liver transplant
Gadolinium allergy
>10% premature ventricular contraction (PVC) burden; and 13) estimated >10% atrial fibrillation (AF) burden based on available clinical data.