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Physician Notification for Aortic Stenosis (DETECT AS Trial)
N/A
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
Subjects with severe aortic stenosis having an aortic valve area of less than or equal to 1.0cm2.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
DETECT AS Trial Summary
This trial is looking at whether electronic provider notification of severe aortic stenosis impacts its management, on the utilization of aortic valve replacement, and on ethnic and racial disparities in AVR utilization.
Who is the study for?
This trial is for patients with severe aortic stenosis, where the opening of their aortic valve is less than or equal to 1.0cm2. It's not for those who already have artificial (bioprosthetic or mechanical) valves in place.Check my eligibility
What is being tested?
The DETECT AS Trial tests if notifying physicians electronically about their patient's severe aortic stenosis improves management and increases the use of valve replacement surgery, especially among different ethnic and racial groups.See study design
What are the potential side effects?
Since this trial involves sending notifications rather than medical treatments, there are no direct side effects from interventions like drugs or surgeries.
DETECT AS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart valve is severely narrowed.
DETECT AS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Establish impact of electronic physician notification letter on the likelihood of AVR utilization for patients with a clinical indication for severe AS
Secondary outcome measures
Impact on mortality rate
Impact on proportion of patients referred to Cardiology/Heart Valve Team
Impact on rate of heart failure hospitalization
+1 moreDETECT AS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Notification Letter ArmExperimental Treatment1 Intervention
Providers that will receive an electronic Physician Notification Letter.
Group II: Control GroupActive Control1 Intervention
Providers that will not be contacted.
Find a Location
Who is running the clinical trial?
Edwards LifesciencesIndustry Sponsor
180 Previous Clinical Trials
60,634 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,197,541 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a replacement valve in your aorta.My heart valve is severely narrowed.
Research Study Groups:
This trial has the following groups:- Group 1: Notification Letter Arm
- Group 2: Control Group
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.
Is there still capacity for enrolment in this experiment?
"Clinicaltrials.gov reports this medical trial is currently enrolling patients, with the initial posting of the study on February 9th 2022 and most recent update occuring April 4th 2022."
Answered by AI
What is the current participant headcount for this investigation?
"Affirmative. Clinicaltrials.gov's data indicates that this research project, which was initially announced on February 9th 2022, is presently enrolling participants. Altogether, the trial needs to recruit roughly 940 patients from a single site."
Answered by AI
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