Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
300 participants
INTERVENTIONAL
2020-06-22
2035-06-22
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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HALT Cohort
Patients who develop HALT
Proteomics Analysis
Determine a panel of circulating proteins that discriminates between patients with and without Hypo-Attenuated Leaflet Thickening (HALT)
Control Group
Patients who do not develop HALT
Proteomics Analysis
Determine a panel of circulating proteins that discriminates between patients with and without Hypo-Attenuated Leaflet Thickening (HALT)
Interventions
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Proteomics Analysis
Determine a panel of circulating proteins that discriminates between patients with and without Hypo-Attenuated Leaflet Thickening (HALT)
Eligibility Criteria
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Inclusion Criteria
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
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
65 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
Catholic Medical Center
OTHER
Minneapolis Heart Institute
OTHER
Massachusetts General Hospital
OTHER
Responsible Party
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Sammy Elmariah
Director, Interventional Cardiology Research
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
Catholic Medical Center
Manchester, New Hampshire, United States
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Role: primary
Role: primary
Other Identifiers
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2020P001793
Identifier Type: -
Identifier Source: org_study_id