Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-27 @ 6:42 AM
Study NCT ID:
NCT07123766
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-14
First Post:
2025-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Investigation for the PoliaValve Aortic Heart Valve- India
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D001022', 'term': 'Aortic Valve Insufficiency'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, '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': '2025-11-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2025-07-28', 'studyFirstSubmitQcDate': '2025-08-08', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Clinical Outcomes Events', 'timeFrame': '12 months following patient enrollment completion', 'description': 'The rate of adverse events will be compared to clinical outcomes for surgically implanted heart valves reported in the literature: a) thromboembolism, b) valve thrombosis, c) major paravalvular leak, d) major hemorrhage, e) endocarditis, f) all-caused death, g) valve related death, h) valve related reoperation, i) valve explant, j) hemorrhage, k) all-cause reoperation'}], 'secondaryOutcomes': [{'measure': 'Effective Orifice Area (EOA)', 'timeFrame': '12 months following patient enrollment completion', 'description': 'Using doppler echocardiography to Measure Effective Orifice Area (EOA)'}, {'measure': 'Mean Pressure Gradient(MPG)', 'timeFrame': '12 months following patient enrollment completion', 'description': 'The mean pressure gradient (MPG) is a measure of the average pressure difference across a valve or a specific area in a fluid system, often measured by transthoracic echocardiogram.'}, {'measure': 'New York Heart Association(NYHA) Improvement Assessment', 'timeFrame': '12 months following patient enrollment completion', 'description': 'Clinically significant improvement (one grade) in the New York Heart Association (NYHA) functional classification status at 365 days compared to baseline. a. Class I - No symptoms and no limitations in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. b. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. c. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100m). Comfortable only at rest. d. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.'}, {'measure': 'Rate of Stroke', 'timeFrame': '12 months following patient enrollment completion', 'description': 'Assessment of patient experiencing a stroke verified by imaging and or physical exam'}, {'measure': 'Rate of Transient Ischemic Attack(TIA)', 'timeFrame': '12 months following patient enrollment completion', 'description': 'Assessment of patient having a transient ischemic attack(TIA) verified by imaging and or physical exam'}, {'measure': 'Intensive Care Unit(ICU) Duration of Stay', 'timeFrame': '30 days post procedure', 'description': 'Length of stay in the ICU post valve implantation defined as arrival time/date in hours and minutes to transfer to floor time/date in hours and minutes.'}, {'measure': 'Ventilation Time', 'timeFrame': '30 days post procedure', 'description': 'Ventilation time in hours defined as arrival time/date in recovery in hours and minutes to date and time extubated in hours and minutes'}, {'measure': 'Rate of New Onset Atrial Fibrillation', 'timeFrame': '12 months post procedure'}, {'measure': 'Length of Stay in Hospital', 'timeFrame': '30 days post procedure'}, {'measure': 'Readmission', 'timeFrame': '30 days post procedure', 'description': 'Patient readmission to the hospital post discharge measured by date/time'}, {'measure': 'Hemolysis screen', 'timeFrame': '12 months post procedure', 'description': 'Hemolysis screen is measured by blood tests including hemoglobin and liver enzyme assessments'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart Valve Diseases', 'Aortic Valve Regurgitation', 'Aortic Valve Disease', 'Polymeric Aortic Valve'], 'conditions': ['AORTIC VALVE DISEASES', 'Aortic Valve Stenosis', 'Aortic Valve Regurgitation']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to conduct a clinical investigation of the HeartHill PoliaValve Aortic Valve to collect evidence on the device's safety and performance.", 'detailedDescription': 'The PoliaValve is indicated as a replacement for diseased, damaged, or malfunctioning native aortic heart valve via open heart surgery. The study is a single-arm, open label, non-randomized multi- center clinical trial. Up to 10 sites in the country of India will enroll up to 50 patients. These patients will follow the study schedule for 1 year after implantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is 45 years or older\n* Provide written informed consent prior to trial procedures after standard of care studies and tests indicate that the patient needs aortic valve replacement\n* Agrees to attend all follow-up assessments for up to 1 year and is willing to comply with specified follow-up evaluations for the clinical trial\n* Diagnosed with severe symptomatic aortic valve stenosis and/or regurgitation\n\nExclusion Criteria:\n\n* Requires multiple valve replacement / repair\n* Requires emergency surgery\n* Has had prior valve surgery\n* Requires a surgical procedure outside of the cardiac area\n* Requires a cardiac procedure other than a CABG or root enlargement or aortic root replacement\n* Requires or are planning another unrelated surgery within 12 months of undergoing implantation of the study device\n* Has active endocarditis/myocarditis or within 3 months to the scheduled surgery\n* Has renal insufficiency as determined by creatinine (S-Cr) level as ≥ 1.5 mg/dl or end-stage renal disease requiring chronic dialysis at screening visit\n* Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months (90 days) prior to planned valve surgery\n* Has acute myocardial infarction (AMI) within 30 days prior to planned valve surgery\n* Has life expectancy to less than 12 months\n* Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM), except patients who have isolated subaortic muscular hypertrophy diagnosed at the time of surgery\n* Diagnosed with abnormal calcium metabolism and/or hyperparathyroidism\n* Echocardiographic left ventricular ejection fraction \\<25%\n* Echocardiographic evidence of an intra-cardiac thrombus or vegetation\n* Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery\n* Documented leukopenia (WBC \\< 4.0 x 103/µL), acute anemia (Hgb \\< 10.0 gm/dl or 6 mmol/L), thrombocytopenia (platelet count \\< 100 x103/µL) or history of bleeding diathesis or coagulopathy\n* Has prior organ transplant or is currently an organ transplant candidate\n* Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial\n* Pregnant, lactating or planning to become pregnant during the duration of participation in trial\n* Currently incarcerated or unable to give voluntary informed consent\n* Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant\n* Requires concomitant left ventricular assist device (LVAD) placement, Impella placement, and/or intra-aortic balloon pump\n* Currently has uncontrolled infection\n* Currently diagnosed as uncontrolled diabetes mellitus (Random BLS \\> 300 mg/dl)'}, 'identificationModule': {'nctId': 'NCT07123766', 'briefTitle': 'Clinical Investigation for the PoliaValve Aortic Heart Valve- India', 'organization': {'class': 'INDUSTRY', 'fullName': 'Suzhou Hearthill Medical Technology Co.,LTD'}, 'officialTitle': 'A Prospective, Multicenter, Single-Arm Study With Objective Performance Criteria Evaluating the Efficacy and Safety of PoliaValve® Artificial Heart Valve', 'orgStudyIdInfo': {'id': 'PoliaValve-SA-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group(PoliaValve)', 'description': 'Patients receiving the PoliaValve (Aortic) from HearrHill Medical', 'interventionNames': ['Device: PoliaValve (Aortic)']}], 'interventions': [{'name': 'PoliaValve (Aortic)', 'type': 'DEVICE', 'description': 'Aortic Valve Replacement', 'armGroupLabels': ['Experimental group(PoliaValve)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Kevin Yan', 'role': 'CONTACT', 'email': 'kevin.yan@hearthillmedical.com', 'phone': '(+86)021-68248839'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suzhou Hearthill Medical Technology Co.,LTD', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}