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Amyloidosis Incidence in High-Risk Cardiac Device Patients

NCT06186167 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2024-02-20

No results posted yet for this study

Summary

This single-practice prospective cohort study aims to enhance the diagnosis of cardiac amyloidosis in high-risk patients undergoing standard cardiac device implantation. By analyzing chest wall fat tissue, which is usually discarded, we aim to determine the diagnostic yield of such biopsies for amyloidosis and to develop a predictive screening model based on clinical, lab, and imaging data. The study, running from December 2023 to December 2024, expects to enroll 100 patients and may provide a new, non-invasive diagnostic avenue for this condition.

Conditions

  • Amyloid
  • Cardiac Amyloidosis
  • Amyloidosis Cardiac
  • Systemic Amyloidosis
  • AL Amyloidosis
  • Infiltrative Cardiomyopathy, Amyloid
  • ATTR Amyloidosis Wild Type

Interventions

PROCEDURE

Chest Wall Fat Tissue Collection

As part of routine cardiac device implantation, chest wall fat tissue is collected for histopathological analysis. This tissue, which is typically discarded, will be used to identify amyloid deposits in high-risk cardiac patients. No additional surgical intervention is performed beyond the standard procedure for device implantation.

Sponsors & Collaborators

  • Midwest Heart & Vascular Specialists

    lead OTHER

Principal Investigators

  • Vasvi Singh, MD · Midwest Heart & Vascular Specialists

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-29
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06186167 on ClinicalTrials.gov