Clinical trial NCT05532956: Evaluation of the Impact of Tricuspid Regurgitation on Patients Lives. Exploration of Experience and Impact on a Daily Basis.
Official title: Evaluation of the Impact of Tricuspid Regurgitation on Patients Lives. Exploration of Experience and Impact on a Daily Basis.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Severe Tricuspid Regurgitation Medically Treated and Not Operated (Without Valve Replacement or Repair)
Keywords: Severe tricuspid regurgitation
Lead sponsor: Gérond'if
Sponsor class: OTHER
Collaborators: name: Edwards Lifesciences
First posted: 2022-09-08
Enrollment: 24
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe tricuspid regurgitation treated medically and not operated (without valve replacement or repair)

Brief summary: The purpose of this study is to objectively assess the impact of the pathology on the patient's life so as to best inform the choices of evaluators "the French National Authority for Health" (HAS) and decision makers "the Economics Committee for Health Products" (CEPS) through the expression of the patients' feelings themselves.

For this, the study will assess the impact of severe tricuspid insufficiency and its symptoms on the quality of life of patients from a physical, psychological and social point of view.

Detailed description: Patients eligible for this study are selected by their cardiologist to participate in one of two interviews:

* Individual semi-structured interview lasting 45 minutes to 1.5 hours conducted by a psychologist These interviews are recorded (voice recording by dictaphone). They address the experience of patients with different degrees of severity of the pathology (severe, massive or torrential regurgitation), questioning the different dimensions of the impact of tricuspid regurgitation on their life, as well as the hierarchy of consequences for their lives and their daily lives.
* Collective interview lasting 1.5 hours to 2 hours which allows to consolidate the information obtained during the individual interviews in order to best assess the impact of the tricuspid regurgitation on the daily life and the patient experience.

Eligibility criteria: Inclusion Criteria:

* Subject, male or female, at least 60 years old,
* Suffering from isolated severe tricuspid insufficiency,
* Symptomatic despite medical treatment,
* Without tricuspid surgery or transcatheter tricuspid surgery, and/or not eligible for surgery,
* Potentially eligible for tricuspid transcatheter therapy (repair or replacement), without considering purely anatomical criteria related to the valve,
* Not suffering from refractory heart failure (stage D) requiring heart transplant or DMCA (mechanical circulatory assist device),
* Without cognitive impairment,
* Not suffering from severe deafness,
* Speaking and understanding French,
* Person not under legal protection and not deprived of liberty

Primary outcomes:
measure: Evaluation of the impact of severe tricuspid insufficiency and its symptoms on patients' quality of life
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Psychologist, Project and Research Manager, Gérond'if
name: Caroline BACLET-ROUSSEL
role: STUDY_CHAIR
References: