Mechanistic Clinical Trial of Advanced Imaging for CRT

Heart Failure, Systolic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03398369
• Other study ID #: UVAMRICRTTRIAL
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2018
• Est. completion date: January 15, 2025

Study information

• Verified date: February 2020
• Source: University of Virginia
• Contact: Kenneth C Bilchick, MD
• Phone: 4349242465
• Email: bilchick[@]virginia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: January 15, 2025
• Est. primary completion date: January 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure, Systolic

Intervention

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.

Locations

Country	Name	City	State
United States	University of Virginia Health System	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

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