Aortic Valve Stenosis Clinical Trial
Official title:
Targeted Testing for Transthyretin Cardiac Amyloid Among Aortic Stenosis Patients-Pilot
NCT number | NCT04363294 |
Other study ID # | STU-2020-0386 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2022 |
Est. completion date | August 2023 |
Verified date | March 2021 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | August 2023 |
Est. primary completion date | September 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 75 Years and older |
Eligibility | Inclusion Criteria: - Successful implantation of a transcatheter heart valve with a commercially available valve (i.e. Sapien 3, Sapien Ultra, Evolut R, Evolut Pro, Evolut Pro+, or Lotus Edge) for native or bioprosthetic aortic stenosis - Pre-implantation echocardiography with tissue Doppler imaging, if feasible - Post-implantation invasive cardiac hemodynamics Exclusion Criteria: - Age <75 years - Moderate to severe paravalvular aortic regurgitation on post-operative echocardiography |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Texas Southwestern Medical Center | Mid America Heart Institute |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Prevalence ATTR with s'<6 plus AVi <0.5 | Prevalence of ATTR among participants with both s'<6 and AVi <0.5 mm Hg/beats per minute | Within 28 days after TAVR when bone scan completed | |
Other | Prevalence ATTR with s'=6 plus AVi <0.5 | Prevalence of ATTR among participants with both s'=6 and AVi <0.5 mm Hg/beats per minute | Within 28 days after TAVR when bone scan completed | |
Other | KCCQ-12 | Kansas City Cardiomyopathy Questionnaire(KCCQ) - a shortened 12 question version of the 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. | 1 year after TAVR | |
Other | Favorable outcome | Proportion of subjects who are alive with reasonable quality of life. Reasonable quality of life is defined as KCCQ-12 =60 without any meaningful worsening (decrease in KCCQ-12 summary score =10). | 1 year after TAVR | |
Primary | Prevalence ATTR with AVi <0.5 | Prevalence of ATTR among participants with AVi <0.5 mm Hg/beats per minute | Within 28 days after TAVR when bone scan completed | |
Primary | Prevalence ATTR with AVi =0.5 | Prevalence of ATTR among participants with AVi =0.5 mm Hg/beats per minute | Within 28 days after TAVR when bone scan completed | |
Secondary | Sensitivity AVi | Sensitivity of AVi <0.5 mm Hg/beats per minute | Within 28 days after TAVR when bone scan completed | |
Secondary | Specificity AVi | Specificity of AVi =0.5 mm Hg/beats per minute | Within 28 days after TAVR when bone scan completed | |
Secondary | Positive predictive value AVi | Positive predictive value of AVi <0.5 at predicting ATTR | Within 28 days after TAVR when bone scan completed | |
Secondary | Negative predictive value AVi | Negative predictive value of AVi =0.5 at ruling out ATTR | Within 28 days after TAVR when bone scan completed |
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