Tricuspid Valve Disease KCCQ Validation

Overview

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.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Shannon Dunlay, M.D., M.S.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Shannon Dunlay, M.D., M.S.

Closed for enrollment

More information

Publications

Publications are currently not available

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