Your session is about to expire
← 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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
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
2,933 Previous Clinical Trials
13,198,181 Total Patients Enrolled
MedtronicIndustry Sponsor
606 Previous Clinical Trials
828,365 Total Patients Enrolled
Catholic Medical CenterOTHER
5 Previous Clinical Trials
2,427 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe aortic stenosis or my heart valve replacement is severely degenerated.I am having a heart valve replacement through my leg using a specific Medtronic device.I cannot take blood thinners in pill form due to health reasons.I have a bleeding disorder or a condition affecting blood clotting.I am older than 65 years.My kidney function is very low.I am on long-term blood thinner medication.You have a serious medical condition that may reduce your life expectancy to less than 12 months.I have a condition that makes my blood clot more than normal.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group
- Group 2: HALT Cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has this intervention achieved regulatory acceptance by the FDA?
"With limited data in support of safety and efficacy, the risk assessment score for this treatment is a 1."
Answered by AI
How many volunteers have been recruited to take part in this experiment?
"Affirmative. Clinicaltrials.gov reveals that this medical experiment, which was initially announced on June 22nd of 2020, is presently enrolling test subjects. A total of 300 patients are required from 3 different sites."
Answered by AI
Are there any vacancies to partake in this clinical trial?
"Affirmative. Clinicaltrials.gov states that this clinical trial is presently enrolling patients, having been initially launched on June 22nd 2020 and last modified on November 2nd 2021. This research needs to find 300 participants from 3 distinct locations."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger