Prevalence of Wildtype Amyloid After TAVR

North Florida Foundation for Research and Education

Overview

Those with abnormal vital signs after TAVR need to be willing to obtain a bone scan to evaluate for wildtype amyloidosis. Positive bone scan findings will require evaluation for primary amyloidosis with blood and urine monoclonal immunoglobulin testing. Primary amyloidosis is a different type of disease which requires different treatment.

This research is interested in determining how common wildtype amyloidosis is after transcatheter aortic valve replacement (TAVR). Amyloidosis is a condition characterized by abnormal protein which can accumulate and impair various organs, including the heart. Research suggests that amyloidosis might be common among TAVR patients, but it is a condition that is not routinely evaluated for. We suspect that wildtype amyloidosis may be especially common among patients with abnormal vital signs after their TAVR procedure.

Study Type

OBSERVATIONAL

Conditions

Amyloidosis

Eligibility

Sex: ALLMin age: 50 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria * Patients that underwent a TAVR procedure at the Malcolm Randall VA Medical Center. * Implant of current generation TAVR (i.e. Sapien S3, Evolut R, or Evolut Pro). * Willingness to obtain bone scintigraphy if evidence of impaired hemodynamics after valve deployment. * Willingness to have blood drawn * Willingness to complete SF12 quality of life KCCQ Exclusion Criteria: --Patient that do not qualify for a TAVR procedure as normal clinical care

Outcomes

Primary Outcomes

Number of participants who die or have poor quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ)

Measurement tool is the Kansas City Cardiomyopathy Questionnaire (KCCQ)

Time frame: 1 to 2 years post TAVR

Data from ClinicalTrials.gov

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