Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
Study NCT ID:
NCT06627959
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-23
First Post:
2024-10-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
StatSeal vs Figure-of-Eight Suture for Vascular Closure in AF Ablation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-22', 'studyFirstSubmitDate': '2024-10-01', 'studyFirstSubmitQcDate': '2024-10-03', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to ambulation (TTA) after sheath removal', 'timeFrame': '1 day', 'description': 'Time to ambulation is defined as the elapsed time between removal of the final sheath and the moment when the patient can stand and walk 20 feet without evidence of venous re-bleeding from the femoral access site.'}], 'secondaryOutcomes': [{'measure': 'Time to haemostasis', 'timeFrame': '1 day', 'description': 'time elapsed between removal of the vascular sheath and first observed and confirmed venous haemostasis, for each access site'}, {'measure': 'Time to discharge eligibility', 'timeFrame': '1 day', 'description': 'time elapsed between removal of the final sheath and when the patient is eligible for hospital discharge based solely on the assessment of the access site, as determined by the medical team'}, {'measure': 'Time to discharge', 'timeFrame': '1 day', 'description': 'time elapsed between removal of the final sheath and when the patient was discharged from the institution'}, {'measure': 'Incidence of major periprocedural adverse events', 'timeFrame': '1 day', 'description': 'defined as adverse events until hospital discharge requiring medical intervention.'}, {'measure': 'Incidence of major adverse events', 'timeFrame': '30 days', 'description': 'Major adverse events are defined as complications requiring medical intervention or hospitalisation'}, {'measure': 'Incidence of minor adverse events', 'timeFrame': '30 days', 'description': 'Minor adverse events are defined as AEs not requiring medical intervention.'}, {'measure': 'Comparison of EuroQol EQ-5D-5L', 'timeFrame': '30 days', 'description': "Comparison of EuroQol 5-level EQ-5D score. The score is made up of two parts: the EQ-5D descriptive system and the EQ visual analogue scale (EQ-VAS). The first part covers five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension offers five response options (no problems, slight problems, moderate problems, severe problems, and extreme problems), from which an EQ-5D index score is calculated, ranging from 0 (death) to 1 (perfect health). The EQ-VAS assesses an individual's self-perceived health for the day on a vertical scale from 0 (worst imaginable health) to 100 (best imaginable health), where participants mark their current health status."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['atrial fibrillation', 'vascular closure', 'Statseal'], 'conditions': ['Atrial Fibrillation (AF)', 'Vascular Access']}, 'descriptionModule': {'briefSummary': 'This study, titled aims to compare two vascular closure techniques after catheter ablation for atrial fibrillation (AF). Catheter ablation is a common procedure used to treat AF, but after the procedure, It is important to close the access site in the blood vessel to prevent bleeding. This study will evaluate whether the StatSeal device, a haemostatic disc, can help patients recover more quickly compared to the traditional figure-of-eight suture technique.\n\nThe primary objective of the study is to determine whether StatSeal reduces the time it takes for patients to start walking after the procedure (known as Time to Ambulation). Secondary objectives include comparing the time to complete haemostasis, discharge eligibility, incidence of adverse events, and patient comfort between the two techniques.\n\nParticipants in the study will be randomly assigned to receive either the StatSeal device or the figure-of-eight suture after their AF ablation procedure. The study will recruit 160 participants across multiple hospital sites, with 80 participants in each group. Both techniques are standard methods, and participants will be closely monitored for safety throughout the study.\n\nBy comparing these two closure techniques, the study aims to improve the recovery process for patients undergoing AF ablation and provide evidence on which method leads to better outcomes and patient experiences.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients age \\>18\n* Elective catheter ablation for atrial fibrillation using a 6 to 14 Fr inner diameter introducer sheath with a minimum of 1 and maximum of 3 femoral venous access sites\n* Willing and able to give informed consent\n\nExclusion Criteria:\n\n* Active systemic or cutaneous infection, or inflammation in vicinity of the groin\n* Platelet count \\< 100,000 cells/mm3\n* BMI \\> 45 kg/m2 or \\< 20 kg/m2\n* Attempted femoral arterial access or inadvertent arterial puncture\n* Procedural complications that interfered with routine recovery, ambulation, or discharge times\n* Incorrect sheath placement\n* Intraprocedural bleeding or thrombotic complications\n* Access site-specific eligibility criteria to exclude problems with gaining access or location of sheath\n* History of bleeding diathesis, coagulopathy, hypercoagulability, or thromboembolic events'}, 'identificationModule': {'nctId': 'NCT06627959', 'briefTitle': 'StatSeal vs Figure-of-Eight Suture for Vascular Closure in AF Ablation', 'organization': {'class': 'OTHER', 'fullName': 'Mid and South Essex NHS Foundation Trust'}, 'officialTitle': 'StatSeal vs Figure-of-Eight Suture for Vascular Closure in AF Ablation', 'orgStudyIdInfo': {'id': '348992'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Statseal', 'description': 'This group shall receive the StatSeal device for vascular closure', 'interventionNames': ['Device: Statseal']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Figure of eight suture', 'description': 'This group shall receive the figure of eight suture (attached to a three-way stopcock) for vascular closure', 'interventionNames': ['Device: Figure of eight suture']}], 'interventions': [{'name': 'Statseal', 'type': 'DEVICE', 'description': 'This is a vascular closure device which works independently of the clotting cascade to seal access sites', 'armGroupLabels': ['Statseal']}, {'name': 'Figure of eight suture', 'type': 'DEVICE', 'description': 'The figure of eight suture is commonly used for vascular access closure', 'armGroupLabels': ['Figure of eight suture']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SS16 5NL', 'city': 'Basildon', 'state': 'Essex', 'country': 'United Kingdom', 'facility': 'The Essex Cardiothoracic Centre', 'geoPoint': {'lat': 51.56844, 'lon': 0.45782}}, {'zip': 'BN21 2UD', 'city': 'Eastbourne', 'country': 'United Kingdom', 'facility': 'East Sussex Healthcare NHS Trust', 'geoPoint': {'lat': 50.76871, 'lon': 0.28453}}, {'zip': 'NR4 7UY', 'city': 'Norwich', 'country': 'United Kingdom', 'facility': 'Norfolk and Norwich University Hospital', 'geoPoint': {'lat': 52.62783, 'lon': 1.29834}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mid and South Essex NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}