Status:
COMPLETED
Impact of a Patient Decision Aid for Treatment of Aortic Stenosis
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
University of Colorado, Denver
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
This project will evaluate the impact of a patient decision aid created by the American College of Cardiology for patients considering treatment of aortic stenosis. The decision aid describes surgical...
Detailed Description
The pilot trial will enroll patients who are coming in to see a valve specialist (cardiac surgeon or interventional cardiologist) to discuss treatment options for aortic stenosis. The study will recru...
Eligibility Criteria
Inclusion
- Adults 18-85 years only
- English speaking
- Severe aortic stenosis, defined as an aortic valve area \< 1 cm2
- Never had AVR or who had previous AVR \> 6 months previous
- Patients perceived by the clinician to be at low or intermediate risk for SAVR
Exclusion
- Concomitant disease of another heart valve or the aorta that required either transcatheter or surgical intervention
Key Trial Info
Start Date :
September 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2021
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT04103931
Start Date
September 23 2019
End Date
September 1 2021
Last Update
January 5 2022
Active Locations (2)
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1
University of Colorado Denver I Anschutz Medical Campus
Aurora, Colorado, United States, 80045
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114