Identifying biomarkers for Hypo-Attenuated Leaflet Thickening in heart patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The HALT Biomarker Study aims to identify a panel of circulating proteins that can distinguish between patients with and without Hypo-Attenuated Leaflet Thickening (HALT). It will also assess changes in these proteins after treatment with systemic anticoagulation and identify proteins that may predict HALT occurrence. The study will enroll adult patients over 65 years old who are undergoing transfemoral transcatheter aortic valve replacement (TAVR) for severe aortic stenosis or bioprosthetic valve degeneration. Blood samples and clinical data will be collected at various time points to achieve these objectives.

Why it matters

Who can join: the full rules

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

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Catholic Medical Center
  Manchester, New Hampshire, United States Recruiting
• Minneapolis Heart Institute
  Minneapolis, Minnesota, United States Not yet recruiting

Study contacts

• Study coordinator: Roukoz Abou Karam
• Email: raboukaram@mgh.harvard.edu

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.