Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-01-25 @ 6:18 AM
Study NCT ID:
NCT02981004
Status:
COMPLETED
Last Update Posted:
2019-02-07
First Post:
2016-10-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PAR I - Patient-to-Annulus Relation I
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}], '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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 304}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-06', 'studyFirstSubmitDate': '2016-10-21', 'studyFirstSubmitQcDate': '2016-11-30', 'lastUpdatePostDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'recording of hemodynamic outcome of a aortic valve in mutual dependence of anatomical facts on the basis of echocardiographic parameter', 'timeFrame': 'postprocedure before discharge (less than 30 days after implant)', 'description': 'Echocardiographic evaluation of the anatomical facts e.g. Left ventricular outflow area'}], 'secondaryOutcomes': [{'measure': 'Mortality 30 days after implant', 'timeFrame': '30 days', 'description': 'Mortality'}, {'measure': 'Morbidity 30 days after implant', 'timeFrame': '30 days', 'description': 'Morbidity'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Aortic valve disease, patient prosthesis mismatch'], 'conditions': ['Aortic Valve Disease']}, 'descriptionModule': {'briefSummary': 'The Prosthesis-to-Annulus Relation I (PAR I) trial is a German multicenter study assessing the relation between the prosthetic GOA and the area of LVOT as potentially new parameter for the prediction of hemodynamic outcome. The results may possibly guide future valve size selection an may allow prediction of functionally relevant PPM (Patient-Prosthesis-Mismatch)', 'detailedDescription': 'Great debates revolve around the hemodynamic performance of prosthetic tissue valves. It is influenced by the design and the specific sizing strategy. Design determines the actual geometric orifice area (GOA), sizing strategy the actual size of the selected valve. Currently, hemodynamic performance is generally assessed by determining the effective orifice area (EOA, derived from the continuity equation by relating flow velocities and LVOT area). The question whether a prosthesis patient mismatch (PPM) is present is then addressed by relating EOA to body surface area (EOAi). However, this relation may not be reasonable because EOAi relates flow velocity twice to patient-specific anatomic parameters (LVOT area and body surface area) . Considering this potential methodological flaw, debate and confusion regarding PPM is easily understood, despite the fact that, intuitively leaving a gradient behind after aortic valve replacement cannot be irrelevant. Thus a reliable and comparable method to determine the presence of PPM is needed. In PAR I Trial the relation between true prothetic GOA and LVOT area will be assesses as a potentially new parameter for prediction of hemodynamic outcome, to possibly guide future valve size selection (inclusive valve-in-valve) and to allow the detection of functionally relevant PPM. In the trial it will be assessed how anatomic dimensions of patients and implanted valves relate to each other and whether they allow the prediction of hemodynamic outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with aortic valve disease selected for tissue valve implantation (routine care)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:1.Patient has an indication for primary, isolated aortic valve implantation 2. Patient is above 18 Years old 3. Patient has signed patient informed consent 4. foreseen implantation of an Epic, Epic supra or Trifecta valve 5. Patient has sinus rhythm\n\nExclusion Criteria:\n\n1. Patient is younger than 18 years\n2. Patient has active endocarditis\n3. Patient is not able or does not want to participate on follow-up\n4. Patient is pregnant or nursing\n5. Surgical widening of outflow tract is planned\n6. Left ventricular ejection fraction is smaller than 50%\n7. Patient has a mitral valve or tricuspid valve insufficiency or stenosis bigger or equal Grade II'}, 'identificationModule': {'nctId': 'NCT02981004', 'acronym': 'PARI', 'briefTitle': 'PAR I - Patient-to-Annulus Relation I', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'PAR I - Prothesis-to-Annulus Relation (PAR) as Predictor of Hemodynamic Outcome in Aortic Valve Replacement', 'orgStudyIdInfo': {'id': 'CS-09-015-GE-TV'}}, 'contactsLocationsModule': {'locations': [{'city': 'Dresden', 'country': 'Germany', 'facility': 'Herzzentrum Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Asklepios St. Georg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '07747', 'city': 'Jena', 'country': 'Germany', 'facility': 'Department of Cardiothoracic Surgery', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '81925', 'city': 'Munich', 'country': 'Germany', 'facility': 'Hospital Bogenhausen', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'city': 'Rotenburg (Wümme)', 'country': 'Germany', 'facility': 'Herz- und Kreislaufzentrum Rotenburg / Fulda', 'geoPoint': {'lat': 53.11032, 'lon': 9.4036}}, {'city': 'Trier', 'country': 'Germany', 'facility': 'Krankenhaus der Barmherzigen Brüder', 'geoPoint': {'lat': 49.75565, 'lon': 6.63935}}, {'city': 'Ulm', 'country': 'Germany', 'facility': 'University Hospital of Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}], 'overallOfficials': [{'name': 'Torsten Doenst, M.D.Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head of Cardiac surgery department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}