Status:
ENROLLING_BY_INVITATION
Promoting Shared Decision Making for Severe Aortic Stenosis
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
University of California, San Francisco
University of Colorado, Denver
Conditions:
Aortic Stenosis
Eligibility:
All Genders
65-85 years
Phase:
NA
Brief Summary
The goal of this study is to increase shared decision making for patients considering treatment for severe aortic stenosis. The main questions it aims to answer are: * Do patient decision aids and cl...
Detailed Description
The goal of this study is to promote shared decision making for patients considering treatment for severe aortic stenosis. The main questions it aims to answer are: * Do patient decision aids and cli...
Eligibility Criteria
Inclusion
- Between 65-85 years of age
- Language is English or Spanish
- Diagnosed with severe aortic stenosis defined as (e.g. an aortic valve area \< 1 cm2 or as determined by clinician)
- Attend a scheduled visit with an Interventional Cardiologist and/or Cardiac Surgeon from the Heart Valve Team at a participating site
Exclusion
- Prior aortic valve replacement surgery
- High risk for either SAVR or TAVI (e.g., Society of Thoracic Surgery score \>8% or clinician determined)
- Prior coronary artery bypass surgery (CABG)
- End stage renal disease on dialysis
- Severe lung disease (chronic obstructive pulmonary disease; COPD) requiring home oxygen
- Advanced Cirrhosis
- Unable to consent for self (proxy respondents are not allowed)
Key Trial Info
Start Date :
March 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2027
Estimated Enrollment :
1300 Patients enrolled
Trial Details
Trial ID
NCT06171737
Start Date
March 27 2024
End Date
October 31 2027
Last Update
June 8 2025
Active Locations (8)
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1
The Regents of the University of California, San Francisco
San Francisco, California, United States, 94117
2
University of Colorado Denver
Aurora, Colorado, United States, 80045-7202
3
Emory University
Atlanta, Georgia, United States, 30308-0000
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114