Improving decision-making for patients with aortic valve stenosis
Structured Shared Decision Making for Patients Undergoing Elective Surgical or Transcatheter Aortic Valve Replacement (TOGETHER): A Randomized-controlled Trial
NA · Insel Gruppe AG, University Hospital Bern · NCT05711186
This study tests if a new way of helping patients with severe aortic stenosis make treatment choices can improve their satisfaction and outcomes compared to standard care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern (other) |
| Locations | 1 site (Bern) |
| Trial ID | NCT05711186 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a structured shared decision-making approach for patients with symptomatic severe aortic stenosis who are considering either surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). The trial aims to enhance patient-centered outcomes by integrating patient values and preferences into the treatment decision process. It is a randomized, open-label, single-center trial involving 140 patients referred for treatment. The study compares the structured decision-making approach against usual care to determine its impact on patient satisfaction and treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients aged 70 years or older with symptomatic severe aortic stenosis who are eligible for both SAVR and TAVR.
Not a fit: Patients with a life expectancy of less than one year or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better-informed treatment choices and improved patient satisfaction for those with aortic valve stenosis.
How similar studies have performed: Other studies have shown that shared decision-making can improve patient outcomes, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 70 years 2. Symptomatic severe aortic stenosis defined by an aortic valve area ≤1.0 cm2 or an aortic valve area indexed to body surface area \<0.6cm2/m2 3. Both SAVR and transfemoral TAVR as reasonable treatment options based on heart team decision Exclusion Criteria: 1. Life expectancy \<1 year irrespective of valvular heart disease 2. Inability to provide informed consent 3. Participation in another clinical trial with an active intervention
Where this trial is running
Bern
- Bern University Hospital, Dep. of Cardiology — Bern, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Thomas Pilgrim, Prof. — Department of Cardiology, University Hospital Bern, Inselspital, Bern
- Study coordinator: Thomas Pilgrim, Prof.
- Email: thomas.pilgrim@insel.ch
- Phone: +41 31 632 50 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Aortic Valve Stenosis, Symptomatic Aortic Stenosis, SAVR, Shared Decision-Making, TAVR, TAVI, Decision Support Techniques