Ignite Creation Date:
2025-12-24 @ 7:03 PM
Ignite Modification Date:
2025-12-25 @ 4:37 PM
Study NCT ID:
NCT05840757
Status:
COMPLETED
Last Update Posted:
2024-05-14
First Post:
2023-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Non-Invasive MOnitoring in Transcathether Aortic Valve Implantation
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-13', 'studyFirstSubmitDate': '2023-04-04', 'studyFirstSubmitQcDate': '2023-04-30', 'lastUpdatePostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac Output', 'timeFrame': 'During aortic valve implantation which generally takes about 40mins', 'description': 'Cardiac Output (CO in L/min)'}, {'measure': 'Cardiac Index', 'timeFrame': 'During aortic valve implantation which generally takes about 40mins', 'description': 'Cardiac Index (CI in L/min/m2)'}, {'measure': 'Systolic blood pressure', 'timeFrame': 'During aortic valve implantation which generally takes about 40mins', 'description': 'systolic blood pressure (sBP in mmHg)'}, {'measure': 'Diastolic blood pressure', 'timeFrame': 'During aortic valve implantation which generally takes about 40mins', 'description': 'diastolic blood pressure (dBP in mmHg)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transcatheter aortic valve implantation', 'hemodynamic parameter'], 'conditions': ['Aortic Valve Disease']}, 'descriptionModule': {'briefSummary': 'In patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) minimal evidence is available for invasive hemodynamic monitoring and no evidence for tools able to measure traditionally invasive parameters non-invasively for peri-procedural guidance and post-interventional management.\n\nThe aim of this study is to evaluate the effectiveness and safety of a non-invasive hemodynamics monitoring tool called ClearSight for monitoring during TAVI procedures compared with standard invasive measurements.', 'detailedDescription': 'In patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) minimal evidence is available for invasive hemodynamic monitoring and no evidence for tools able to measure traditionally invasive parameters non-invasively for peri-procedural guidance and post-interventional management.\n\nThe aim of this study is to evaluate the effectiveness and safety of a non-invasive hemodynamics monitoring tool called ClearSight for monitoring during TAVI procedures compared with standard invasive measurements.\n\nThe ClearSight monitoring system works non-invasively by utilizing an inflatable finger cuff which adjusts automatically to measure the arterial blood pressure which enables the calculation of parameters such as cardiac output or index. Multiple studies have demonstrated the reliability and feasibility of continuous non-invasive monitoring, in different settings, however it was never performed in patients undergoing TAVI.\n\nThe ClearSight monitoring system will be directly compared to invasive measurements of hemodynamic parameters during the procedure. In addition, information regarding baseline hemodynamics and its changes during/after procedure may give important information on peri- and post-procedural management and short-term outcomes and discharge planning. A tool, providing this information non-invasively with the same accuracy might result in a major improvement in daily practice..'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Adult patients (\\>18 years old) with severe aortic stenosis undergoing elective TAVI.\n\nExclusion Criteria:\n\n* Emergency indication for TAVI\n* Severe tricuspid regurgitation\n* Severe mitral stenosis or severe regurgitation\n* Invasive right heart catheterization impossible\n* Dependency on right ventricle pacing immediately after TAVI implantation\n* Vulnerable subjects\n* Known or suspected non-compliance, drug or alcohol abuse\n* Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation affecting this study\n* Previous enrolment into the current investigation'}, 'identificationModule': {'nctId': 'NCT05840757', 'acronym': 'NIMO-TAVI', 'briefTitle': 'Non-Invasive MOnitoring in Transcathether Aortic Valve Implantation', 'organization': {'class': 'OTHER', 'fullName': 'University of Basel'}, 'officialTitle': 'Non-Invasive MOnitoring in Transcathether Aortic Valve Implantation - A Single-center, Prospective, Interventional Study With the ClearSight® Finger Cuff', 'orgStudyIdInfo': {'id': 'Basel'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Hemodynamic Monitoring', 'description': 'Simultaneous measurement of hemodynamic parameters such as Cardiac output, cardiac index and blood pressure with invasive right heart catheterization and non-invasive application of the Clearsight Finger Cuff.', 'interventionNames': ['Device: HemoSphere ClearSight Module']}], 'interventions': [{'name': 'HemoSphere ClearSight Module', 'type': 'DEVICE', 'description': 'The Clear Sight system consists of a finger cuff connected to a monitor It will be applied to the patients finger before and removed after the TAVI procedure.', 'armGroupLabels': ['Hemodynamic Monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'state': 'Canton of Basel-City', 'country': 'Switzerland', 'facility': 'University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Basel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Structural Cardiology', 'investigatorFullName': 'Thomas Nestelberger', 'investigatorAffiliation': 'University of Basel'}}}}