Evaluation of the Impact of Tricuspid Regurgitation on Patients Lives. Exploration of Experience and Impact on a Daily Basis.

NCT ID: NCT05532956

Last Updated: 2022-09-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2022-10-31

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.

Conditions

Severe Tricuspid Regurgitation Medically Treated and Not Operated (Without Valve Replacement or Repair)

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Individual semi-structured interview

A semi-structured individual interview lasting a maximum of 1.5 hour ,conducted by a psychologist, remotely (telephone, videoconference) or at home

No interventions assigned to this group

Collective interview

Group interviews lasting a maximum of 2 hours will consolidate the information obtained during individual interviews

No interventions assigned to this group

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

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edwards Lifesciences

INDUSTRY

Sponsor Role: collaborator

Gérond'if

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caroline BACLET-ROUSSEL

Role: STUDY_CHAIR

Psychologist, Project and Research Manager, Gérond'if

Central Contacts

Isabelle Dufour

Role: CONTACT

isabelle.dufour@gerondif.org

+33 (0) 185781010

Adrien Besseiche, PhD

Role: CONTACT

adrien.besseiche@gerondif.org

+33 (0) 185781010

Other Identifiers

2022-A00641-42

Identifier Type: -

Identifier Source: org_study_id