Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT05532956
Status:
UNKNOWN
Last Update Posted:
2022-09-08
First Post:
2022-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Impact of Tricuspid Regurgitation on Patients Lives. Exploration of Experience and Impact on a Daily Basis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014262', 'term': 'Tricuspid Valve Insufficiency'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-05', 'studyFirstSubmitDate': '2022-09-05', 'studyFirstSubmitQcDate': '2022-09-05', 'lastUpdatePostDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Evaluation of the impact of severe tricuspid insufficiency and its symptoms on patients' quality of life", 'timeFrame': '4 hours', 'description': 'These are individual interviews conducted by a psychologist and collective support to consolidate the information obtained during the individual interviews.\n\nThis is a purely qualitative analysis. It is not intended to create a new questionnaire or validate existing questionnaires'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Severe tricuspid regurgitation'], 'conditions': ['Severe Tricuspid Regurgitation Medically Treated and Not Operated (Without Valve Replacement or Repair)']}, 'descriptionModule': {'briefSummary': '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.\n\nFor 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.', 'detailedDescription': 'Patients eligible for this study are selected by their cardiologist to participate in one of two interviews:\n\n* 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.\n* 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with severe tricuspid regurgitation treated medically and not operated (without valve replacement or repair)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject, male or female, at least 60 years old,\n* Suffering from isolated severe tricuspid insufficiency,\n* Symptomatic despite medical treatment,\n* Without tricuspid surgery or transcatheter tricuspid surgery, and/or not eligible for surgery,\n* Potentially eligible for tricuspid transcatheter therapy (repair or replacement), without considering purely anatomical criteria related to the valve,\n* Not suffering from refractory heart failure (stage D) requiring heart transplant or DMCA (mechanical circulatory assist device),\n* Without cognitive impairment,\n* Not suffering from severe deafness,\n* Speaking and understanding French,\n* Person not under legal protection and not deprived of liberty'}, 'identificationModule': {'nctId': 'NCT05532956', 'acronym': 'EVOQUE', 'briefTitle': 'Evaluation of the Impact of Tricuspid Regurgitation on Patients Lives. Exploration of Experience and Impact on a Daily Basis.', 'organization': {'class': 'OTHER', 'fullName': "Gérond'if"}, 'officialTitle': 'Evaluation of the Impact of Tricuspid Regurgitation on Patients Lives. Exploration of Experience and Impact on a Daily Basis.', 'orgStudyIdInfo': {'id': '2022-A00641-42'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Individual semi-structured interview', 'description': 'A semi-structured individual interview lasting a maximum of 1.5 hour ,conducted by a psychologist, remotely (telephone, videoconference) or at home'}, {'label': 'Collective interview', 'description': 'Group interviews lasting a maximum of 2 hours will consolidate the information obtained during individual interviews'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Isabelle Dufour', 'role': 'CONTACT', 'email': 'isabelle.dufour@gerondif.org', 'phone': '+33 (0) 185781010'}, {'name': 'Adrien Besseiche, PhD', 'role': 'CONTACT', 'email': 'adrien.besseiche@gerondif.org', 'phone': '+33 (0) 185781010'}], 'overallOfficials': [{'name': 'Caroline BACLET-ROUSSEL', 'role': 'STUDY_CHAIR', 'affiliation': "Psychologist, Project and Research Manager, Gérond'if"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Gérond'if", 'class': 'OTHER'}, 'collaborators': [{'name': 'Edwards Lifesciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}