Recruiting

Advanced Imaging

Sponsor:

University of Virginia

Code:

NCT03398369

Conditions

Heart Failure, Systolic

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

Interventions

CMR/CTA Guidance for CRT

Study Details

Brief 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.

Conditions

Heart Failure, Systolic

Study ID

NCT03398369

Start date

Jan 5, 2018

Status verified date

Feb, 2020

Completion date

Jan 15, 2025

Anticipated

Primary completion date

Jan 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention

CMR-Guided CRT

no intervention: Control

Standard CRT

Interventions

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.

Primary outcome measure

  • Left ventricular end-systolic volume (LVESV) improvement [ Time Frame: One Year ]

Central Contacts and Locations

Central contacts

Kenneth C Bilchick, MD

4349242465bilchick@virginia.edu

Hollis Phillips, BA

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

Locations

University of Virginia Health System

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

John Hoover

434-243-4861jrh5r@hscmail.mcc.virginia.edu

More Information

Sponsor

University of Virginia

Last update posted

Feb 6, 2020

Last verified

Feb, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2020-02-06.