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Search / Trial NCT06171737

Promoting Shared Decision Making for Severe Aortic Stenosis

Launched by MASSACHUSETTS GENERAL HOSPITAL · Dec 14, 2023

Trial Information

Current as of July 23, 2025

Enrolling by invitation

Keywords

Aortic Valve Stenosis Decision Making, Shared Decision Aid Continuing Medical Education Cardiology Transcatheter Aortic Valve Replacement

ClinConnect Summary

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 clinician skills training course improve the quality of decisions, and do they work well for different patient populations?
* Are heart clinics able to reach the majority of patients with decision aids before their specialist visit and do the majority of clinicians complete the training course?

This study is a batched stepped wedge cluster randomized trial with 8 sites, about 56 surgeons and inte...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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)

About Massachusetts General Hospital

Massachusetts General Hospital (MGH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing medical research and patient care. As a prominent teaching hospital affiliated with Harvard Medical School, MGH plays a pivotal role in clinical trials across a wide range of disciplines, including cardiology, oncology, neurology, and more. The institution is dedicated to fostering innovative research that translates into effective therapies and improved health outcomes. MGH's Clinical Trials Office provides comprehensive support to facilitate the design, implementation, and management of clinical studies, ensuring adherence to the highest ethical standards and regulatory compliance. With a focus on collaboration and patient-centered care, MGH strives to enhance medical knowledge and contribute to the future of healthcare.

Locations

Boston, Massachusetts, United States

Philadelphia, Pennsylvania, United States

St. Louis, Missouri, United States

Chapel Hill, North Carolina, United States

Dallas, Texas, United States

San Francisco, California, United States

Aurora, Colorado, United States

Atlanta, Georgia, United States

Atlanta, Georgia, United States

Portland, Oregon, United States

Patients applied

0 patients applied

Trial Officials

Karen Sepucha, PhD

Principal Investigator

Massachusetts General Hospital

Sammy Elmariah, MD

Principal Investigator

University of California, San Francisco

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported