Nctid:
NCT06611579
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-02"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000014262", "term"=>"Tricuspid Valve Insufficiency"}], "ancestors"=>[{"id"=>"D000006349", "term"=>"Heart Valve Diseases"}, {"id"=>"D000006331", "term"=>"Heart Diseases"}, {"id"=>"D000002318", "term"=>"Cardiovascular Diseases"}], "browseLeaves"=>[{"id"=>"M17014", "name"=>"Tricuspid Valve Insufficiency", "asFound"=>"Tricuspid Valve Regurgitation", "relevance"=>"HIGH"}, {"id"=>"M9437", "name"=>"Heart Valve Diseases", "relevance"=>"LOW"}, {"id"=>"M9419", "name"=>"Heart Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>50}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-11-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2029-10-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-20", "studyFirstSubmitDate"=>"2024-09-19", "studyFirstSubmitQcDate"=>"2024-09-20", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-10-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Absence of device or procedure related major adverse events", "timeFrame"=>"30 days"}, {"measure"=>"Change in TR grade from baseline", "timeFrame"=>"30 days"}], "secondaryOutcomes"=>[{"measure"=>"Device and procedure related complications", "timeFrame"=>"30 days and 12 months", "description"=>"Rate of Device and procedure related complications"}, {"measure"=>"NYHA functional classification", "timeFrame"=>"30 days, 6 months, 1 year, and through study completion, an average of 1 year", "description"=>"Change in NYHA functional class from baseline"}, {"measure"=>"Six-minute-walk test", "timeFrame"=>"30 days, 6 months, 1 year, and through study completion, an average of 1 year", "description"=>"Change in distance from baseline"}, {"measure"=>"Health status - KCCQ", "timeFrame"=>"30 days, 6 months, 1 year, and through study completion, an average of 1 year", "description"=>"Change in quality of life from baseline"}, {"measure"=>"TR grade", "timeFrame"=>"30 days, 6 months, 1 year, and through study completion, an average of 1 year", "description"=>"Change in TR Grade from baseline"}, {"measure"=>"Hospitalization", "timeFrame"=>"30 days, 6 months, 1 year, and through study completion, an average of 1 year", "description"=>"Rate of all-cause hospitalization"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isUnapprovedDevice"=>true, "isFdaRegulatedDevice"=>true}, "conditionsModule"=>{"conditions"=>["Tricuspid Valve Regurgitation"]}, "descriptionModule"=>{"briefSummary"=>"Prospective, multi-center study to assess safety and performance of the inQB8 MonarQ Tricuspid Valve Replacement System.", "detailedDescription"=>"The study is a multi-center, prospective, single-arm study to assess safety and performance of the inQB8 Medical Technologies MonarQ Tricuspid Valve Replacement System."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Anatomically suitable for the MonarQ TTVR System\n* Symptomatic, tricuspid regurgitation (TR) that is severe or greater\n* Adequately treated for heart failure based upon medical standards\n* Hemodynamically stable\n\nExclusion Criteria:\n\n* Need for emergent or urgent surgery for any reason, any planned cardiac surgery within the next 12 months (365 days), or any planned percutaneous cardiac procedure within the next 90 days\n* Refractory Heart Failure (HF) that requires or required advanced intervention\n* Any condition, in the opinion of the investigator, making it unlikely the patient will be able to complete all protocol procedures and follow-up.\n* Currently participating in another investigational biologic, drug or device study"}, "identificationModule"=>{"nctId"=>"NCT06611579", "briefTitle"=>"Clinical Study of the InQB8 TTVR System", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"inQB8 Medical Technologies, LLC"}, "officialTitle"=>"A Clinical Study of the InQB8 Transcatheter Tricuspid Valve Replacement System", "orgStudyIdInfo"=>{"id"=>"CIP-21001"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Treatment", "description"=>"Treatment with the inQB8 MonarQ Transcatheter Tricuspid Valve Replacement System", "interventionNames"=>["Device: Transcatheter Tricuspid Valve Replacement"]}], "interventions"=>[{"name"=>"Transcatheter Tricuspid Valve Replacement", "type"=>"DEVICE", "otherNames"=>["inQB8 MonarQ Transcatheter Tricuspid Valve Replacement System"], "description"=>"Replacement of the tricuspid valve using a transcatheter approach", "armGroupLabels"=>["Treatment"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"11030", "city"=>"Manhasset", "state"=>"New York", "country"=>"United States", "contacts"=>[{"name"=>"Kristine McGowan", "role"=>"CONTACT", "email"=>"KMcGowan@northwell.edu", "phone"=>"516-881-7035"}, {"name"=>"Bruce Rutkin", "role"=>"CONTACT"}, {"name"=>"Elana Koss", "role"=>"CONTACT"}], "facility"=>"North Shore University Hospital", "geoPoint"=>{"lat"=>40.79788, "lon"=>-73.69957}}, {"zip"=>"19104", "city"=>"Philadelphia", "state"=>"Pennsylvania", "country"=>"United States", "contacts"=>[{"name"=>"Marisa Konig", "role"=>"CONTACT", "email"=>"Marisa.Konig@pennmedicine.upenn.edu", "phone"=>"215-662-8456"}, {"name"=>"Wilson Szeto", "role"=>"CONTACT"}], "facility"=>"Penn Presbyterian Medical Center", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}, {"zip"=>"75093", "city"=>"Plano", "state"=>"Texas", "country"=>"United States", "contacts"=>[{"name"=>"Saba Ilyas", "role"=>"CONTACT", "email"=>"Saba.Ilyas@bswhealth.org", "phone"=>"469-814-4853"}, {"name"=>"Robert Smith", "role"=>"CONTACT"}], "facility"=>"Baylor Heart Hospital", "geoPoint"=>{"lat"=>33.01984, "lon"=>-96.69889}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"inQB8 Medical Technologies, LLC", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
