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

September 5, 2022 updated by: Gérond'if

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with severe tricuspid regurgitation treated medically and not operated (without valve replacement or repair)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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
Collective interview
Group interviews lasting a maximum of 2 hours will consolidate the information obtained during individual interviews

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the impact of severe tricuspid insufficiency and its symptoms on patients' quality of life
Time Frame: 4 hours

These are individual interviews conducted by a psychologist and collective support to consolidate the information obtained during the individual interviews.

This is a purely qualitative analysis. It is not intended to create a new questionnaire or validate existing questionnaires
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gérond'if

Collaborators

Edwards Lifesciences

Investigators

  • Study Chair: Caroline BACLET-ROUSSEL, Psychologist, Project and Research Manager, Gérond'if

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

September 5, 2022

First Submitted That Met QC Criteria

September 5, 2022

First Posted (Actual)

September 8, 2022

Study Record Updates

Last Update Posted (Actual)

September 8, 2022

Last Update Submitted That Met QC Criteria

September 5, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-A00641-42

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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