Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT06455566
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-03-26
First Post:
2024-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vascular Access for Minimally-invasive Leadless Pacemaker Implantation Through the Right Jugular routE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2024-06-03', 'studyFirstSubmitQcDate': '2024-06-07', 'lastUpdatePostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of effective of jugular access', 'timeFrame': '[0 - 1 Month]', 'description': 'Feasibility of jugular access for leadless pacemaker implantation, defined as the percentage of patients with a successful leadless pacemaker implantation through the jugular vein.'}, {'measure': 'Rate of effective same-day discharge', 'timeFrame': '[0 - 1 Month]', 'description': 'Feasibility of same-day discharge after implantation of a leadless pacemaker through the jugular vein, defined as a successful same-day discharge with no readmission during the first postoperative month.'}, {'measure': 'Incidence of major cardiovascular event', 'timeFrame': '[0 - 12 Month]', 'description': 'Incidence of major complications related to the implantation of a leadless through the jugular vein:\n\n* pericardial complications (effusion, tamponade, pericardiocentesis)\n* jugular venous complications (bleeding, hematoma, arteriovenous fistula, vascular surgery)\n* carotid artery complications (bleeding, transient ischemic attack or stroke, vascular surgery)\n* pacemaker malfunction\n* infection\n* cardiac rhythm complications (atrioventricular block, ventricular fibrillation ou tachycardia, cardiac arrest)\n* air embolism'}], 'secondaryOutcomes': [{'measure': 'Description of procedural characteristics', 'timeFrame': 'During implantation procedure', 'description': 'Procedural characteristics of leadless pacemaker implantation through the jugular vein (duration, position, number of attempts, ...).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Leadless Pacemaker', 'Same-day Discharge']}, 'referencesModule': {'references': [{'pmid': '38426911', 'type': 'RESULT', 'citation': 'El-Chami MF, Garweg C, Clementy N, Al-Samadi F, Iacopino S, Martinez-Sande JL, Roberts PR, Tondo C, Johansen JB, Vinolas-Prat X, Cha YM, Grubman E, Bordachar P, Stromberg K, Fagan DH, Piccini JP. Leadless pacemakers at 5-year follow-up: the Micra transcatheter pacing system post-approval registry. Eur Heart J. 2024 Apr 7;45(14):1241-1251. doi: 10.1093/eurheartj/ehae101.'}, {'pmid': '30653690', 'type': 'RESULT', 'citation': 'Saleem-Talib S, van Driel VJ, Chaldoupi SM, Nikolic T, van Wessel H, Borleffs CJW, Ramanna H. Leadless pacing: Going for the jugular. Pacing Clin Electrophysiol. 2019 Apr;42(4):395-399. doi: 10.1111/pace.13607. Epub 2019 Feb 25.'}, {'pmid': '36031774', 'type': 'RESULT', 'citation': 'Saleem-Talib S, van Driel VJ, Nikolic T, van Wessel H, Louman H, Borleffs CJW, van der Heijden J, Cox M, Ramanna H. The jugular approach for leadless pacing: A novel and safe alternative. Pacing Clin Electrophysiol. 2022 Oct;45(10):1248-1254. doi: 10.1111/pace.14587. Epub 2022 Sep 12.'}]}, 'descriptionModule': {'briefSummary': 'Leadless pacemakers (LP) are associated with a lower risk of revision compared with transvenous pacemakers. However, LPs implantation is associated with a 0.6% risk of complication at the femoral vein puncture site (e.g. arteriovenous fistula, haemorrhage, pseudoaneurysm, etc.). As a consequence, the need for prolonged in-hospital monitoring after LP implantation though the right femoral (RF)vein is a barrier to same-day discharge. Recently, right internal jugular (RIJ) vein access has emerged an alternative to right RF vein access for LP implantation (with a regulatory approval for MEDTRONIC Micra LP).\n\nThe aims of this registry are the following :\n\n* evaluate the feasibility of RIJ access for LP implantation;\n* confirm the acute and chronic safety of RIJ access for LP implantation;\n* compare RIJ to RF (historical cohort) vein access regarding procedural characteristics and outcomes;\n* evaluate the feasibility of same-day discharge avec LP implantation through the RIJ vein.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients with a guideline-based pacemaker indication and eligible to leadless pacemaker implantation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication of pacemaker implantation\n* Eligible to leadless pacemaker\n\nExclusion Criteria:\n\n* Contraindication to right internal jugular vein access\n* Age \\< 18 year-old\n* Patient already included in a clinical study'}, 'identificationModule': {'nctId': 'NCT06455566', 'acronym': 'VAMPIRE', 'briefTitle': 'Vascular Access for Minimally-invasive Leadless Pacemaker Implantation Through the Right Jugular routE', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Vascular Access for Minimally-invasive Leadless Pacemaker Implantation Through the Right Jugular routE', 'orgStudyIdInfo': {'id': 'RYTHMO-2024-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Leadless pacemaker implantation through right internal jugular vein', 'interventionNames': ['Device: Leadless pacemaker implantation through right internal jugular vein']}], 'interventions': [{'name': 'Leadless pacemaker implantation through right internal jugular vein', 'type': 'DEVICE', 'description': 'Leadless pacemaker implantation through right internal jugular vein', 'armGroupLabels': ['Leadless pacemaker implantation through right internal jugular vein']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'country': 'France', 'facility': 'Angers University Hospital', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Caen', 'country': 'France', 'facility': 'Caen University Hospital', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Grenoble', 'country': 'France', 'facility': 'Grenoble University Hospital', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Lille', 'country': 'France', 'facility': 'Lille University Hospital', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Lyon University Hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Metz', 'country': 'France', 'facility': 'Metz-Thionville Regional Hospital', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'Le Millénaire Private Hospital', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nîmes', 'country': 'France', 'facility': 'Les Franciscaines Private Hospital', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'city': 'Rennes', 'country': 'France', 'facility': 'Rennes University Hospital', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Saint Pierre de La Réunion', 'country': 'France', 'facility': 'La Réunion University Hospital'}, {'city': 'Strasbourg', 'country': 'France', 'facility': 'Strasbourg University Hospital', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'Toulouse University Hospital', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Tours', 'country': 'France', 'facility': 'Tours University Hospital', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}