Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-27 @ 8:33 AM
Study NCT ID:
NCT06696560
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-20
First Post:
2024-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2028-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-16', 'studyFirstSubmitDate': '2024-11-12', 'studyFirstSubmitQcDate': '2024-11-16', 'lastUpdatePostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries.', 'timeFrame': 'Within 2 years .', 'description': 'To reduce operation duration,so less hospital stay period. Echocardiography assessment intraoperative and postoperative.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatic Heart Disease With Valvulitis']}, 'descriptionModule': {'briefSummary': 'To compare intraoperative and immediate postoperative outcomes of mini-sternotomy versus mini-thoracotomy as less invasive techniques in patients with isolated aortic valvular and subvalvular disease requiring surgery according to inclusion criteria.', 'detailedDescription': '1. It has been demonstrated that minimally invasive aortic valve replacement (MIAVR) approaches are safe and effective for the treatment of aortic valve diseases. To date, the main advantage of these approaches is represented by the reduced surgical trauma, with a subsequent reduced complication rate and faster recovery. This makes such approaches an appealing choice also for frail patients \\[obese, aged, chronic obstructive pulmonary disease (COPD)(1).\n2. Minimally invasive aortic valve replacement (MIAVR) has been increasingly accepted in the surgical community as a potential alternative to conventional sternotomy, with advantages of reduced trauma, improved cosmotic and reduced hospitalization(2).\n3. The Mini sternotomy (MS) approach represents the most common technique used for Minimally invasive AVR. The MS approach is achieved through 6 to 10cm midline vertical skin incision, performing a partial J sternotomy at the third to fifth intercostal space (3). MIAVR via right mini thoracotomy (RT) is performed through five to seven cm skin incision placed at the level of the second intercostal space without rib resection. After sacrificing the right internal thoracic artery(4).\n4. Despite these excellent results, there have been an increasing number of cases performed via minimally invasive aortic valve replacement (MIAVR). This approach has now become an established alternative to FS in order to reduce the "invasiveness" of the surgical procedure, while maintaining the same efficacy, quality and safety of a conventional approach (5).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with isolated Aortic valve and subvalvular disease.\n2. sexes included with acceptance of patients to participate in this study and approval of Ethical Committee.\n\nExclusion Criteria:\n\n1. Patients ages who less than 16 yrs and more than 60yrs.\n2. Emergent open heart surgery.\n3. Patients with current Infective endocarditis.\n4. Patients with chest deformity pectus excavatum or carinatum due to difficult access.\n5. The patient refused to sign the informed consent to participate in the research.\n6. Patients with Aortic root abscess or Aortic dilatation at root or ascending parts.'}, 'identificationModule': {'nctId': 'NCT06696560', 'briefTitle': 'Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries', 'orgStudyIdInfo': {'id': 'AssiutU 1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries.', 'description': 'Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries.', 'interventionNames': ['Other: Minimal Invasive Approaches in Aortic surgeries.']}], 'interventions': [{'name': 'Minimal Invasive Approaches in Aortic surgeries.', 'type': 'OTHER', 'description': 'Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries', 'armGroupLabels': ['Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries.']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yahia Abd almonem Sayed', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries.', 'investigatorFullName': 'Yahia Abd almonem Sayed', 'investigatorAffiliation': 'Assiut University'}}}}