Prevalence of Wildtype Amyloid After TAVR

Amyloidosis Clinical Trial

Official title:

Prevalence of Wildtype Amyloid Among TAVR Patients With Impaired Hemodynamics

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03825406
• Other study ID #: #: 201802928
• Status: Withdrawn
• Start date: March 20, 2019
• Est. completion date: March 20, 2019

Study information

• Verified date: March 2019
• Source: North Florida Foundation for Research and Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 20, 2019
• Est. primary completion date: March 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Amyloidosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
North Florida Foundation for Research and Education

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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