NCT03398369

Mechanistic Clinical Trial of Advanced Imaging for CRT

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 20 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure, Systolic

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-01-05
• Primary completion: 2025-01-15
• Completion: 2025-01-15
• First posted: 2018-01-12
• Last updated: 2020-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study