Evaluation of the Impact of Tricuspid Regurgitation on Pa... | NCT05532956

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

NCT05532956

Sponsor

Gérond'if

Status

Unknown status

Last Update Posted

Sep 8, 2022Actual

Enrollment

24Estimated

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2022Estimated

Primary Completion Date

Sep 2022Estimated

Completion Date

Oct 2022Estimated

First Submitted Date

Sep 5, 2022

First Submission Date that Met QC Criteria

Sep 5, 2022

First Posted Date

Sep 8, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2022

Last Update Posted Date

Sep 8, 2022Actual

Name	Class
Edwards Lifesciences	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	4 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Isabelle Dufour	Contact	+33 (0) 185781010		isabelle.dufour@gerondif.org
Adrien Besseiche, PhD	Contact	+33 (0) 185781010		adrien.besseiche@gerondif.org

Overall Officials

Name	Affiliation	Role
Caroline BACLET-ROUSSEL	Psychologist, Project and Research Manager, Gérond'if	Study Chair

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014262	Tricuspid Valve Insufficiency

Ancestor Terms

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided