Prevalence of Wildtype Amyloid After TAVR

NCT ID: NCT03825406

Last Updated: 2019-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-20

Study Completion Date

2019-03-20

Brief Summary

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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

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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.

Conditions

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Amyloidosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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North Florida Foundation for Research and Education

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anthony Bavry, MD

Role: PRINCIPAL_INVESTIGATOR

ACC AHA

Study Documents

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Document Type: Study Protocol

Type Study Protocol To request an electronic copy send email to [email protected] or [email protected]

View Document

Document Type: Individual Participant Data Set

De-identified data set for primary and secondary outcomes measures To request an electronic copy send email to [email protected] or [email protected]

View Document

Other Identifiers

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#: 201802928

Identifier Type: -

Identifier Source: org_study_id

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