Brief Title
The HALT Biomarker Study
Official Title
Circulating Biomarkers of Hypo-Attenuated Leaflet Thickening After Transcatheter Aortic Valve Replacement
Brief Summary
The purpose of the HALT Biomarkers study are to identify a panel of circulating proteins that discriminates between patients with and without Hypo-Attenuated Leaflet Thickening (HALT) and can be used to supplement the diagnosis of HALT; to characterize changes in circulating proteins after treatment of HALT with systemic anticoagulation; and to identify circulating proteins that predict the occurrence of HALT. The study population will be adult patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS) or bioprosthetic valve degeneration. Enrollment will continue until 30 patients with HALT are identified for completion of phase 1. Based on a HALT incidence rate of 10%, we anticipate enrolling 300 patients. Patients are enrolled prior to undergoing transfemoral TAVR. Blood samples, clinical data and echocardiograms will be collected at the following timepoints: baseline (pre-TAVR, T0), post-TAVR (pre-discharge, T1), 30-day follow-up (window 3-9 weeks, T2), and 6-month follow-up (T3). Cardiac 4D CT will be performed at the 30-day follow-up visit to screen for the occurrence of HALT. Patients with HALT will be treated with systemic anticoagulation for 5-6 months, at which point a follow-up CT scan and blood sample will be obtained. Control subjects will also undergo a 6-month study visit with blood sample collection. The study will be conducted within two phases. Phase 1 will serve as a derivation / discovery study in which candidate protein biomarkers of HALT will be identified. Once this is successfully completed, a second cohort will be enrolled within phase 2. Phase 2 will be performed under the auspices a future contract or amendment and will seek to cross-validate the initial study findings.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Derivation of the panel of circulating proteins indicative of HALT
Secondary Outcome
Cross-validation of the panel of circulating proteins indicative of HALT
Condition
Aortic Stenosis
Intervention
Proteomics Analysis
Study Arms / Comparison Groups
HALT Cohort
Description: Patients who develop HALT
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
300
Start Date
June 22, 2020
Completion Date
June 22, 2035
Primary Completion Date
June 22, 2030
Eligibility Criteria
Inclusion Criteria: 1. Age > 65 years 2. Subject with severe native AS or severe bioprosthetic valve degeneration 3. Subject undergoing transfemoral TAVR using a Medtronic Evolut R, Evolut Pro or Evolut Pro+ transcatheter heart valve Exclusion Criteria: 1. Chronic anticoagulation therapy 2. Contraindication to systemic oral anticoagulation therapy 3. Chronic kidney disease with EGFR<30 ml/min 4. Bleeding diathesis or known coagulopathy 5. Hypercoagulable state 6. Life-expectancy <12 months due to other medical conditions (e.g., malignancy, severe Alzheimer's disease, etc.) 7. The patient is currently participating in another investigational device or drug study that has not reached its primary objective/endpoint 8. Pregnant, lactating, or planning pregnancy within next 12 months
Gender
All
Ages
65 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, 617-643-0156, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04552275
Organization ID
2020P001793
Responsible Party
Principal Investigator
Study Sponsor
Massachusetts General Hospital
Collaborators
Medtronic
Study Sponsor
, ,
Verification Date
September 2020