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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
Must not have
Contraindication to systemic oral anticoagulation therapy
Bleeding diathesis or known coagulopathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot take blood thinners in pill form due to health reasons.
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I have a bleeding disorder or a condition affecting blood clotting.
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My kidney function is very low.
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I am on long-term blood thinner medication.
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I have a condition that makes my blood clot more than normal.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
3,010 Previous Clinical Trials
13,308,720 Total Patients Enrolled
MedtronicIndustry Sponsor
618 Previous Clinical Trials
763,713 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
Aortic Stenosis Research Study Groups: Control Group, HALT Cohort
Aortic Stenosis 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
~167 spots leftby Jun 2030
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