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Targeted Testing for ATTR Among Aortic Stenosis Patients-Pilot

NCT04363294 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-03-23

No results posted yet for this study

Summary

Our ultimate goal is to design a multi-center randomized trial to test the hypothesis that targeted testing for transthyretin cardiac amyloid (ATTR) will improve survival and health status among aortic stenosis patients who undergo transcatheter aortic valve replacement (TAVR). The hypothesis of this pilot study is to evaluate if invasive cardiac hemodynamics obtained after TAVR, by using the AortoVentricular index (AVi), can be used as a novel test to help identify participants with ATTR.

Aim 1. To determine if an abnormal AVi value can identify ATTR among aortic stenosis patients undergoing TAVR.

Aim 2. To determine if s' from echocardiography plus AVi can enhance the prediction of ATTR among aortic stenosis patients undergoing TAVR.

Aim 3. To design a pilot trial to improve patient outcomes after TAVR by targeted testing for ATTR.

Conditions

  • Aortic Valve Stenosis
  • Cardiac Amyloidosis

Interventions

DIAGNOSTIC_TEST

PYP scan

99mTc-labeled pyrophosphate

Sponsors & Collaborators

  • Mid America Heart Institute

    collaborator OTHER

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Anthony A Bavry, MD MPH · UT Southwestern Medical Center

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-31
Primary Completion
2022-09-30
Completion
2023-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04363294 on ClinicalTrials.gov