Nctid:
NCT06227286
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000008944", "term"=>"Mitral Valve Insufficiency"}], "ancestors"=>[{"id"=>"D000006349", "term"=>"Heart Valve Diseases"}, {"id"=>"D000006331", "term"=>"Heart Diseases"}, {"id"=>"D000002318", "term"=>"Cardiovascular Diseases"}], "browseLeaves"=>[{"id"=>"M11910", "name"=>"Mitral Valve Insufficiency", "asFound"=>"Mitral 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"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>176}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-03-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-02", "completionDateStruct"=>{"date"=>"2028-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-02-02", "studyFirstSubmitDate"=>"2024-01-17", "studyFirstSubmitQcDate"=>"2024-01-17", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-05", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2028-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Prevalence of Afterload mismatch", "timeFrame"=>"Within 1 years after transcatheter Mitral valve edge-to-edge repair", "description"=>"postoperative-LVEF / preoperative-LVEF \\<85% OR postoperative-LVEDVi / preoperative-LVEDVi \\>110%"}], "secondaryOutcomes"=>[{"measure"=>"Major adverse composite events", "timeFrame"=>"Within 1 years after transcatheter Mitral valve edge-to-edge repair", "description"=>"Cardiovascular death, acute heart failure, hospitalization caused by chronic heart failure, myocardial infarction, unplanned coronary revascularization (PCI/PTCA/CABGs), stroke"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Mitral Regurgitation"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this multicenter, randomized, double-blind controlled study is to learn about the individuals after transcatheter edge-to-edge mitral valve repair (TEER). The main questions it aims to answer are: (1) can enhanced external counterpulsation (EECP) reduce the prevalence of afterload mismatch after TEER? (2) can EECP prevent the major adverse cardiac events after TEER? Participants will be randomly assigned into EECP or Sham-EECP intervention after TEER. Researchers will compare the EECP and Sham-EECP to see if it helps reduce the prevalence of afterload mismatch after TEER."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"100 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\n* Consent to participate\n* Age \\> 18 years\n* Moderate or severe Mitral Regurgitation\n* Patients who meet the indications for transcatheter Mitral valve edge-to-edge repair and have undergone TEERM\n\nExclusion Criteria\n\n* Lower extremity deep vein thrombosis, active thrombophlebitis\n* Moderate or severe aortic stenosis/insufficiency\n* Moderate pulmonary hypertension (mean pulmonary pressure \\>50mmHg)\n* Aortic aneurysm/cerebral aneurysm Uncontrolled hypertension (\\>180/110mmHg) Arrhythmias that may interfere with the ECG gating function of the EECP device Hemorrhagic disease or obvious bleeding tendency Limb infection Pregnant/lactating women"}, "identificationModule"=>{"nctId"=>"NCT06227286", "briefTitle"=>"Enhanced External Counter Pulsation on Afterload Mismatch Rate in Post-TEER (PAMPER)", "organization"=>{"class"=>"OTHER", "fullName"=>"Sun Yat-sen University"}, "officialTitle"=>"Enhanced External Counter Pulsation on Afterload Mismatch Rate in Post-TEER (PAMPER): A Multicenter, Randomized, Double-blind Controlled Study", "orgStudyIdInfo"=>{"id"=>"PAMPER Study"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"EECP Arm", "description"=>"Participants would be assigned for treating with EECP initiated with 0.030 MPa, 30-45 minutes per day, 5 days per week, 7 weeks in total.", "interventionNames"=>["Device: EECP"]}, {"type"=>"SHAM_COMPARATOR", "label"=>"Sham-EECP Arm", "description"=>"Participants would be assigned for treating with Sham-EECP initiated with 70 mmHg, 30-45 minutes per day, 5 days per week, 7 weeks in total.", "interventionNames"=>["Device: Sham-EECP"]}], "interventions"=>[{"name"=>"EECP", "type"=>"DEVICE", "description"=>"EECP: 30-45 minutes/day, 5 days/week, 7 weeks, initiates with 0.030MPa.", "armGroupLabels"=>["EECP Arm"]}, {"name"=>"Sham-EECP", "type"=>"DEVICE", "description"=>"EECP: 30-45 minutes/day, 5 days/week, 7 weeks, constant to 75 mmHg.", "armGroupLabels"=>["Sham-EECP Arm"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"510000", "city"=>"Guangzhou", "state"=>"Guangdong", "country"=>"China", "contacts"=>[{"name"=>"Xiaodong Zhuang, PhD", "role"=>"CONTACT", "email"=>"zhuangxd3@mail.sysu.edu.cn", "phone"=>"+86 13760755035"}], "facility"=>"First Affiliated Hospital, Sun Yat-Sen University", "geoPoint"=>{"lat"=>23.11667, "lon"=>113.25}}, {"zip"=>"510000", "city"=>"Guangzhou", "state"=>"Guangdong", "country"=>"China", "contacts"=>[{"name"=>"Longgen Xiong", "role"=>"CONTACT", "email"=>"xionglg66@126.com", "phone"=>"+8613922761639"}], "facility"=>"Second Affiliated Hospital of Guangzhou Medical University", "geoPoint"=>{"lat"=>23.11667, "lon"=>113.25}}, {"zip"=>"510000", "city"=>"Guangzhou", "state"=>"Guangdong", "country"=>"China", "contacts"=>[{"name"=>"Zhuoshan Huang, PhD", "role"=>"CONTACT", "email"=>"huangzhsh@mail.sysu.edu.cn", "phone"=>"+86 13728059476"}], "facility"=>"Third Affiliated Hospital, Sun Yat-Sun University", "geoPoint"=>{"lat"=>23.11667, "lon"=>113.25}}, {"zip"=>"522000", "city"=>"Jieyang", "state"=>"Guangdong", "country"=>"China", "contacts"=>[{"name"=>"Mingwei Xu, PhD", "role"=>"CONTACT", "email"=>"versy@163.com", "phone"=>"+86 13828186368"}], "facility"=>"Jieyang People's Hospital", "geoPoint"=>{"lat"=>23.5418, "lon"=>116.36581}}, {"zip"=>"515041", "city"=>"Shantou", "state"=>"Guangdong", "country"=>"China", "contacts"=>[{"name"=>"Jilin Li, PhD", "role"=>"CONTACT", "email"=>"lijilin@126.com", "phone"=>"+86 13592852807"}], "facility"=>"Second Affiliated Hospital of Shantou University Medical College", "geoPoint"=>{"lat"=>23.36814, "lon"=>116.71479}}, {"zip"=>"528400", "city"=>"Zhongshan", "state"=>"Guangdong", "country"=>"China", "contacts"=>[{"name"=>"Li Feng, PhD", "role"=>"CONTACT", "email"=>"lifengdoc@126.com", "phone"=>"+86 13902593410"}], "facility"=>"Zhongshan People's Hospital", "geoPoint"=>{"lat"=>21.31992, "lon"=>110.5723}}], "centralContacts"=>[{"name"=>"Xiaodong Zhuang, PhD", "role"=>"CONTACT", "email"=>"zhuangxd3@mail.sysu.edu.cn", "phone"=>"+86 13760755035"}], "overallOfficials"=>[{"name"=>"Xiaodong Zhuang, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"First Affiliated Hospital, Sun Yat-Sen University"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Sun Yat-sen University", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"First Affiliated Hospital, Sun Yat-Sen University", "class"=>"OTHER"}, {"name"=>"Third Affiliated Hospital, Sun Yat-Sen University", "class"=>"OTHER"}, {"name"=>"Second Affiliated Hospital of Shantou University Medical College", "class"=>"UNKNOWN"}, {"name"=>"Second Affiliated Hospital of Guangzhou Medical University", "class"=>"OTHER"}, {"name"=>"Zhongshan People's Hospital, Guangdong, China", "class"=>"OTHER"}, {"name"=>"Jieyang People's Hospital", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Professor", "investigatorFullName"=>"Xiao-dong Zhuang", "investigatorAffiliation"=>"Sun Yat-sen University"}}}}
