← Back to Search

Proteomics Analysis for Heart Valve Disease (HALT Trial)

Phase 1
Recruiting
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

HALT Trial Summary

This trial is designed to find a panel of proteins that could help diagnose a condition called Hypo-Attenuated Leaflet Thickening (HALT), which is a problem with the leaflets in the heart valves. The study will also look at how well treatment with a blood thinner works for this condition.

Who is the study for?
Adults over 65 with severe aortic stenosis or valve degeneration, who are getting a specific heart valve replacement (Medtronic Evolut series). Not for those with bleeding disorders, on chronic anticoagulation therapy, severe kidney disease, short life expectancy due to other conditions, currently in another study, or pregnant.Check my eligibility
What is being tested?
The HALT Biomarker Study aims to find protein markers in the blood that can help diagnose and track treatment response of Hypo-Attenuated Leaflet Thickening (HALT) after patients receive transcatheter aortic valve replacements. It involves two phases: discovery and validation.See study design
What are the potential side effects?
Since this trial focuses on proteomics analysis rather than drug intervention, direct side effects from the procedure are not specified. However, systemic anticoagulation used to treat HALT may increase bleeding risk.

HALT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have severe aortic stenosis or my heart valve replacement is severely degenerated.
Select...
I am having a heart valve replacement through my leg using a specific Medtronic device.
Select...
I am older than 65 years.

HALT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Derivation of the panel of circulating proteins indicative of HALT
Establish the rate at which these characteristics indicative of future HALT
Secondary outcome measures
Cross-validation of the panel of circulating proteins indicative of HALT

HALT Trial Design

2Treatment groups
Experimental Treatment
Group I: HALT CohortExperimental Treatment1 Intervention
Patients who develop HALT
Group II: Control GroupExperimental Treatment1 Intervention
Patients who do not develop HALT

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,945 Previous Clinical Trials
13,203,578 Total Patients Enrolled
MedtronicIndustry Sponsor
610 Previous Clinical Trials
828,439 Total Patients Enrolled
Catholic Medical CenterOTHER
5 Previous Clinical Trials
2,427 Total Patients Enrolled

Media Library

Control Group Clinical Trial Eligibility Overview. Trial Name: NCT04552275 — Phase 1
Hypoattenuated Leaflet Thickening Research Study Groups: Control Group, HALT Cohort
Hypoattenuated Leaflet Thickening Clinical Trial 2023: Control Group Highlights & Side Effects. Trial Name: NCT04552275 — Phase 1
Control Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT04552275 — Phase 1
~180 spots leftby Jun 2030
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top