An interventional study of Decision Aid and Shared Decision Making Skills Training in Aortic Stenosis, sponsored by Massachusetts General Hospital. Enrolling by invitation at 8 sites in United States. Open to participants aged 65 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Health services research
Among 189 studies in Aortic Valve Stenosis with a site in United States — 44 open to participants now, 68 under way, 3 of them phase 3. Aortic Valve Stenosis · United States.
Among the 189 studies in Aortic Valve Stenosis with a site in United States, this one is the 14th largest by planned enrollment of the 125 interventional ones that give a count, is one of 13 that started in 2024, is one of 102 with no phase, reaches primary completion later than 36 of the 67 other live ones, and was the 160th registered.
1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.
This study's planned enrollment of 1,300 is above the median of 126 across 554 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →44 of the 189 studies in Aortic Valve Stenosis with a site in United States are open now.
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 209 Aortic Valve Stenosis studies recruiting now, 163 (78%) set no upper age limit and 9 (4%) stop at 75 or younger; 25 take children under 18; 14 take healthy volunteers.
This study: 65 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →189 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 7 · Phase 3 7 · Phase 4 6
First in 2000; this study’s year is marked. 13 started in 2024.
Median enrollment 172 across the 125 interventional studies, 102 across the 64 observational. Of the 106 that completed or were terminated, 50 (47%) have results posted.
82 of 189 have an industry lead sponsor. The 10 most frequent:
Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Massachusetts General Hospital has 6 studies filed under Aortic Valve Stenosis — fewer than ten, so there is no comparison to draw.
13 of the studies in Aortic Valve Stenosis with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06689839EnCompass Technologies, Inc.Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR | 2026-12 |
| NCT05603026University Hospitals Cleveland Medical CenterMRI in Transcatheter Aortic Valve Replacement Patients | 2026-12-30 |
| NCT07827105AccurKardia, Inc.ECG-based AI Screening for Cases of Undiagnosed Moderate-to-Severe Aortic Stenosis in the Primary Care Setting | 2027-02 |
| NCT06077201Vanderbilt University Medical CenterHome-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions | 2027-02-01 |
| NCT06580158Mayo ClinicAI in Outpatient Practice for Diagnosing Aortic Stenosis and Diastolic Dysfunction | 2027-03 |
Among the 189 studies in Aortic Valve Stenosis with a site in United States, from their registry updates:
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:
All participating sites will start in the usual care group and then will be randomly assigned a time to switch to the intervention group. Participants will complete surveys before and after their specialist visit.
Researchers will compare data from patients seen during usual care with data from those seen after the interventions are implemented to see if there are improvements in the quality of decisions.
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:
This study is a batched stepped wedge cluster randomized trial with 8 sites, about 56 surgeons and interventional cardiologists, and will enroll about 1300 patients. All participating sites will start in the usual care group and then will be randomly assigned a time to switch to the intervention group. The interventions include a patient decision aid that was created by the American College of Cardiology CardioSmart program and a online shared decision making skills training course for clinicians. The coordinating center will provide implementation support to sites when they transition to the intervention arm. Data collection is similar across usual care and intervention groups. Patient participants will complete surveys before and after their specialist visit. Clinician participants will be randomly selected to complete a survey after the patient visit. Limited clinical data will be collected from the medical record.
Researchers will compare data from patients seen during usual care with data from those seen after the interventions are implemented to see if there are improvements in the quality of decisions. Researchers will also calculate percentage of patients reached with decision aids and percentage of clinicians who complete training at each site to measure the success of the implementation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group will receive usual care without any support for using the decision aid and without any access to the clinician training.
The patients in this group will receive a decision aid that covers the main treatment options for aortic stenosis. The clinicians in this group will receive a 60-minute online training session that will provide practical tips, interactive case studies and tools for conducting shared decision making conversations covering core competencies
Behavioral: Decision Aid · Behavioral: Shared Decision Making Skills Training
The American College of Cardiology decision aid: Treatment Options for Severe Aortic Stenosis for patients deciding between Tavi and Surgery
60-minute online training session that will provide practical tips, interactive case studies and tools for conducting shared decision making conversations covering core competencies
Shared Decision Making
Shared Decision Making Process scale; Scores range 0-4 with higher scores indicating greater shared decision making occurred.
Time frame: About 1 week post visit
Reach
% of eligible patients who receive decision aid
Time frame: About 1 week post visit
Patient Knowledge
Multiple choice knowledge score ranging from 0-100; higher scores indicate higher knowledge
Time frame: About 1 week post visit
Preference-treatment concordance
% of patients who received preferred treatment within 6 months of visit
Time frame: About 1 week post visit
Patient experience
CAHPS MD-patient communication subscale and visit rating score
Time frame: About 1 week post visit
Clinician satisfaction
% of clinicians who mark "very" or "extremely" satisfied with visit
Time frame: About 1 week post visit
Adoption
% of eligible clinicians who complete the shared decision making skills training
Time frame: 4 weeks from the start of intervention period for each site
Timeliness (time to decision)
% of patients who report stage of decision making is "made a decision"
Time frame: About 1 week post visit
Timeliness (burden)
% of visits where clinicians report visit length is "longer than normal"
Time frame: About 1 week post visit
Plan to share: Yes — To promote research replicability, transparency and future use of the data, de-identified data sets will be created and will be available, by request, to outside researchers. The Data Package (comprised of the de-identified Analyzable Data Set, Full Protocol, metadata, data dictionary, full statistical analysis plan, and analytic code from the project) will be deposited in the Patient-Centered Outcomes Research Institute's Data Repository at the ICPSR. Participant information sheets for the study will indicate that de-identified information will be deposited in an open access service to promote use of the data by other researchers. No information that contains identifiers or that could be used to link an individual to the data will be included in the de-identified data set. No data will be provided from qualitative transcripts as this may lead to identifying information about participants. However, codes abstracted from qualitative transcripts may be made available.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: The PCORI-designated repository will make the data available for third-party requests when PCORI makes the Final Research Report available, or at the time of publication the primary results, whichever comes first.
Access criteria: Researchers may access the data through the PCORI-designated repository (ICPSR's website) once it is made available.
Started Mar 2024 (actual). Primary completion is estimated for May 2027, 38 months after the start.
Of 177 non-industry interventional studies with no phase under Aortic Valve Stenosis, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 79. This study's planned 38 months is below that.
Counting every sponsor, half of 288 studies reached it within 33 months; a quarter within 18 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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