| NCT ID | NCT04552275 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Massachusetts General Hospital |
| Condition | Aortic Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2020-06-22 |
| Primary Completion | 2030-06-22 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 300 participants in total. It began in 2020-06-22 with a primary completion date of 2030-06-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Roukoz Abou Karam
✉ raboukaram@mgh.harvard.eduFrequently Asked Questions
Who can join the NCT04552275 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Aortic Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04552275 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04552275 currently recruiting?
Yes, NCT04552275 is actively recruiting participants. Contact the research team at raboukaram@mgh.harvard.edu for enrollment information.
Where is the NCT04552275 trial being conducted?
This trial is being conducted at Boston, United States, Minneapolis, United States, Manchester, United States.
Who is sponsoring the NCT04552275 clinical trial?
NCT04552275 is sponsored by Massachusetts General Hospital. The trial plans to enroll 300 participants.