Prevalence of Wildtype Amyloid After TAVR

Prevalence of Wildtype Amyloid Among TAVR Patients With Impaired Hemodynamics

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03825406

Enrollment

Registered

2019-01-31

Start date

2019-03-20

Completion date

2019-03-20

Last updated

2019-03-22

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

Conditions

Amyloidosis

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to 100 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of participants who die or have poor quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ)	1 to 2 years post TAVR	Measurement tool is the Kansas City Cardiomyopathy Questionnaire (KCCQ)

Outcome results