Severe Tricuspid Regurgitation Medically Treated and Not Operated (Without Valve Replacement or Repair)EVOQUENCT05532956
Evaluation of the Impact of Tricuspid Regurgitation on Patients Lives. Exploration of Experience and Impact on a Daily Basis.
An observational study of Severe Tricuspid Regurgitation Medically Treated and Not Operated (Without Valve Replacement or Repair), run by Gérond'if.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Severe Tricuspid Regurgitation Medically Treated and Not Operated (Without Valve Replacement or Repair)
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with severe tricuspid regurgitation treated medically and not operated (without valve replacement or repair)
Who may be able to join
- 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),
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- Without cognitive impairment,
- Not suffering from severe deafness,
- Speaking and understanding French,
- Person not under legal protection and not deprived of liberty
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Keywords
- Severe tricuspid regurgitation
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the impact of severe tricuspid insufficiency and its symptoms on patients' quality of life
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
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study startSep 2022 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Tricuspid Regurgitation Medically Treated and Not Operated (Without Valve Replacement or Repair)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gérond'if
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences
- Responsible party
- Sponsor
- Investigators
- Caroline BACLET-ROUSSEL, Study chair, Psychologist, Project and Research Manager, Gérond'if
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532956
- Sponsor's protocol ID
- 2022-A00641-42
- Acronym
- EVOQUE
- Status last verified
- Aug 2022
- First submitted
- 5 Sep 2022
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Tricuspid Regurgitation on Patients Lives. Exploration of Experience and Impact on a Daily Basis.
- ClinicalTrials.gov ID
- NCT05532956
- Acronym / sponsor ID
- EVOQUE / 2022-A00641-42
- Keywords
- Severe tricuspid regurgitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Gérond'ifUniversity, hospital or other
- Collaborators
- Edwards Lifesciences
- Study start
- Sep 2022 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with severe tricuspid regurgitation treated medically and not operated (without valve replacement or repair)
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline BACLET-ROUSSEL study chair
Psychologist, Project and Research Manager, Gérond'if
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Tricuspid Regurgitation Medically Treated and Not Operated (Without Valve Replacement or Repair), run by Gérond'if.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabelle Dufour (+33 (0) 185781010, isabelle.dufour@gerondif.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the impact of severe tricuspid insufficiency and its symptoms on patients' quality of life (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.