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New treatment option for Aortic Stenosis
Official title The HALT Biomarker Study
ClinicalTrials.gov ID: NCT04552275
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- Age \> 65 years
- Subject with severe native AS or severe bioprosthetic valve degeneration
- Subject undergoing transfemoral TAVR using a Medtronic Evolut R, Evolut Pro or Evolut Pro+ transcatheter heart valve
You likely can't join if
- Chronic anticoagulation therapy
- Contraindication to systemic oral anticoagulation therapy
- Chronic kidney disease with EGFR\<30 ml/min
- Bleeding diathesis or known coagulopathy
- Hypercoagulable state
- Life-expectancy \<12 months due to other medical conditions (e.g., malignancy, severe Alzheimer's disease, etc.)
See the full eligibility criteria
- Age \> 65 years
- Subject with severe native AS or severe bioprosthetic valve degeneration
- Subject undergoing transfemoral TAVR using a Medtronic Evolut R, Evolut Pro or Evolut Pro+ transcatheter heart valve
- Chronic anticoagulation therapy
- Contraindication to systemic oral anticoagulation therapy
- Chronic kidney disease with EGFR\<30 ml/min
- Bleeding diathesis or known coagulopathy
- Hypercoagulable state
- Life-expectancy \<12 months due to other medical conditions (e.g., malignancy, severe Alzheimer's disease, etc.)
- The patient is currently participating in another investigational device or drug study that has not reached its primary objective/endpoint
- Pregnant, lactating, or planning pregnancy within next 12 months
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Minneapolis, Minnesota, United States
- Manchester, New Hampshire, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Minneapolis, Minnesota, United States; Manchester, New Hampshire, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.