Mechanistic Clinical Trial of Advanced Imaging for CRT

Advanced Imaging and Inflammatory Markers to Define Mechanisms of Response to CRT

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03398369

Enrollment

180

Registered

2018-01-12

Start date

2018-01-05

Completion date

2025-01-15

Last updated

2020-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Systolic

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.

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.

Interventions

DIAGNOSTIC_TESTCMR/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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 90 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Left ventricular end-systolic volume (LVESV) improvement	One Year	Change in LVESV with cardiac resynchronization therapy (CRT)

Countries

United States

Contacts

Primary ContactKenneth C Bilchick, MD

bilchick@virginia.edu4349242465

Backup ContactHollis Phillips, BA

hp9r@hscmail.mcc.virginia.edu434-243-0046

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026