What side effects are associated with this type of intervention?

The most common treatments for aortic stenosis, particularly aortic valve replacement (AVR), include surgical AVR (SAVR) and transcatheter AVR (TAVR). SAVR can lead to side effects such as bleeding, infection, arrhythmias, and anesthesia-related complications. TAVR, being less invasive, still carries risks like vascular complications, stroke, and paravalvular leak. Both treatments require careful patient selection and management to mitigate these risks.

What prior FDA approvals exist?

The FDA has approved several treatments for aortic stenosis, particularly focusing on aortic valve replacement (AVR). Traditional surgical AVR has been a long-standing treatment. More recently, transcatheter aortic valve replacement (TAVR) has gained approval for patients at high or intermediate surgical risk. TAVR involves the use of devices such as the Edwards SAPIEN valve and Medtronic's CoreValve. These treatments align with the goals of the Electronic Provider Notification trial, which aims to improve provider adherence to clinical guidelines for managing severe aortic stenosis.

What other types of research exist?

Promising novel alternatives to Electronic Provider Notification for Aortic Stenosis patients in 2024 include advanced telemedicine platforms, AI-driven decision support systems, and enhanced patient monitoring technologies. These alternatives aim to improve provider awareness and adherence to clinical guidelines by leveraging modern technology for better communication, decision-making, and patient management.

← Back to Search

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

No Placebo-Only Group

Summary

This trial tests if sending doctors alerts about patients with severe heart valve problems can improve treatment and reduce care differences among different groups.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My heart valve is severely narrowed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Establish impact of electronic physician notification letter on the likelihood of AVR utilization for patients with a clinical indication for severe AS

Secondary study objectives

Impact on mortality rate

Impact on proportion of patients referred to Cardiology/Heart Valve Team

Impact on rate of heart failure hospitalization

+1 more

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

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.

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Aortic Stenosis (AS) are Surgical Aortic Valve Replacement (SAVR) and Transcatheter Aortic Valve Replacement (TAVR). Both procedures replace the narrowed aortic valve with a prosthetic valve, improving blood flow from the heart to the body. This is vital for AS patients as it alleviates symptoms like chest pain and shortness of breath, and reduces the risk of heart failure and mortality. The DETECT AS Trial emphasizes electronic provider notifications to improve the timely recognition and management of severe AS, ensuring adherence to clinical guidelines and increasing the utilization of these life-saving treatments.

Lessons Learnt from Recent Trials in Ischemic Heart Disease.Statistical Appraisal of 6 Recent Clinical Trials in Cardiology: JACC State-of-the-Art Review.Utility of Consumer Physical Activity Trackers as an Intervention Tool in Cardiovascular Disease Prevention and Treatment.