Prevalence of Wildtype Amyloid After TAVR

March 20, 2019 updated by: North Florida Foundation for Research and Education

Prevalence of Wildtype Amyloid Among TAVR Patients With Impaired Hemodynamics

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.

Study Overview

Status

Withdrawn

Conditions

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.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This research is interested in determining how prevalent wildtype amyloidosis is after transcatheter aortic valve replacement (TAVR) patients with impaired hemodynamics. 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 this condition is not routinely evaluated for. We suspect that wildtype amyloidosis may be especially common among patients with abnormal vital signs after their TAVR procedure.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North Florida Foundation for Research and Education

Investigators

  • Principal Investigator: Anthony Bavry, MD, ACC AHA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2019

Primary Completion (Actual)

March 20, 2019

Study Completion (Actual)

March 20, 2019

Study Registration Dates

First Submitted

January 30, 2019

First Submitted That Met QC Criteria

January 30, 2019

First Posted (Actual)

January 31, 2019

Study Record Updates

Last Update Posted (Actual)

March 22, 2019

Last Update Submitted That Met QC Criteria

March 20, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #: 201802928

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Study Protocol
    Information comments: Type Study Protocol To request an electronic copy send email to Anthony.bavry@va.gov or debra.robertson1@va.gov
  2. Individual Participant Data Set
    Information comments: De-identified data set for primary and secondary outcomes measures To request an electronic copy send email to Anthony.bavry@va.gov or Debra.robertson1@va.gov

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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