Tricuspid Valve Disease KCCQ Validation
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 23-000298
About this study
The purpose of this study is to use patient interviews and qualitative research methods to determine the gaps in the current KCCQ in patients with severe tricuspid regurgitation (TR). Also, to construct a KCCQ-TR supplement and perform cognitive debriefing with patients. Additionally, to examine the psychometric properties of the current KCCQ in patients with severe TR.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- All race/ethnicity categories, English speaking, men and women.
- Age ≥ 21 years.
- Current severe/massive/torrential tricuspid regurgitation (TR), considered symptomatic from TR.
- Goal Age/Sex/Race Distribution: ≥ 20% non-white, 40% women/men, 40% < 65/ ≥ 65 years of age.
Exclusion Criteria:
- Unwillingness to participate.
- Cognitive barriers which would make it difficult to participate in discussion.
- Non-English speaking.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 1/10/23. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available