Mechanistic Clinical Trial of Advanced Imaging for CRT

University of Virginia180 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

180

Conditions

Heart Failure, Systolic

Interventions

CMR/CTA Guidance for CRTDIAGNOSTIC_TEST

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Virginia Health System

Charlottesville, Virginia, United States

RECRUITING

Outcomes

Primary Outcomes

Left ventricular end-systolic volume (LVESV) improvement

Change in LVESV with cardiac resynchronization therapy (CRT)

Time frame: One Year

Central Contacts

Kenneth C Bilchick, MD

CONTACT

4349242465 bilchick@virginia.edu

Hollis Phillips, BA

CONTACT

434-243-0046 hp9r@hscmail.mcc.virginia.edu

Data from ClinicalTrials.gov

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