NCT03825406

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2019

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

March 20, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2019

Completed
Last Updated

March 22, 2019

Status Verified

March 1, 2019

Enrollment Period

Same day

First QC Date

January 30, 2019

Last Update Submit

March 20, 2019

Conditions

Amyloidosis

Outcome Measures

Primary Outcomes (1)

  • 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)

    1 to 2 years post TAVR

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Patient that do not qualify for a TAVR procedure as normal clinical care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Amyloidosis

Condition Hierarchy (Ancestors)

Proteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Anthony Bavry, MD

    ACC AHA

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2019

First Posted

January 31, 2019

Study Start

March 20, 2019

Primary Completion

March 20, 2019

Study Completion

March 20, 2019

Last Updated

March 22, 2019

Record last verified: 2019-03