Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-25 @ 8:07 PM
Study NCT ID:
NCT07246135
Status:
RECRUITING
Last Update Posted:
2025-11-24
First Post:
2025-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Leadless Pacemaker Registry: Outcomes and Follow-up From the University Hospital of St. Pölten
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001919', 'term': 'Bradycardia'}], '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2035-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-09-16', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2035-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedural success rate', 'timeFrame': 'Periprocedural / at Day 1', 'description': 'Successful implantation of a leadless pacemaker with acceptable electrical parameters and no need for conversion to a transvenous system'}, {'measure': 'Incidence of acute complications', 'timeFrame': 'Within 30 days after implantation', 'description': 'Rate of periprocedural complications (e.g., vascular complications, arrhythmias, pericardial effusion, device dislodgement)'}], 'secondaryOutcomes': [{'measure': 'Device-related complication rate (medium- and long-term)', 'timeFrame': 'Up to 10 years after implantation', 'description': 'Cumulative incidence of complications requiring medical or surgical intervention (e.g., device malfunction, infection, need for extraction, upgrade)'}, {'measure': 'Ventricular pacing burden', 'timeFrame': 'Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter', 'description': 'Percentage of ventricular pacing and triggered pacing as recorded by device interrogation'}, {'measure': 'All-cause mortality', 'timeFrame': 'Throughout follow-up (up to 10 years)'}, {'measure': 'Hospitalizations related to cardiac arrhythmias or heart failure', 'timeFrame': 'Throughout follow-up (up to 10 years)'}, {'measure': 'Quality of Life after Implantation', 'timeFrame': '1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter', 'description': 'Change in 12-Item Short Form Health Survey (SF-12) questionnaire score / The SF-12 questionnaire is a validated health-related quality of life instrument with two subscales: Physical Component Summary (PCS) and Mental Component Summary (MCS). Each subscale ranges from 0 to 100 points, where higher scores indicate better health-related quality of life.'}, {'measure': 'Electrical performance of the device', 'timeFrame': 'Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter', 'description': 'Pacing thresholds (in Volts at 0.24 ms pulse width)'}, {'measure': 'Electrical performance of the device', 'timeFrame': 'Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter', 'description': 'Sensing Amplitude (R-wave, in millivolts \\[mV\\])'}, {'measure': 'Electrical performance of the device', 'timeFrame': 'Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter', 'description': 'Lead impedance (in Ohms \\[Ω\\])'}, {'measure': 'Electrical performance of the device', 'timeFrame': 'Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter', 'description': 'Estimated battery longevity (in years)'}, {'measure': 'Left ventricular ejection fraction on Echocardiography', 'timeFrame': '1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter', 'description': 'in %'}, {'measure': 'Left ventricular dimensions on Echocardiography', 'timeFrame': '1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter', 'description': 'end-diastolic and end-systolic diameters, in mm'}, {'measure': 'Right ventricular function on Echocardiography', 'timeFrame': '1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter', 'description': 'Tricuspid Annular Plane Systolic Excursion (TAPSE) in mm'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Registry', 'Leadless Pacemaker', 'Pacemaker', 'Cardiac Pacing', 'Pacemaker Complication', 'Leadless Pacemaker Outcomes', 'Heart Conduction System Disease', 'Bradycardia'], 'conditions': ['Pacemaker', 'Leadless Pacemaker', 'Cardiac Pacing, Artificial', 'Registries']}, 'descriptionModule': {'briefSummary': 'The registry for leadless pacemakers will collect and annually analyze the data of all leadless pacemaker implantations at the University Hospital St. Pölten, including demographic information, indications, procedural details, acute, medium- and long-term complications during follow-up. Due to the partially novel nature of the signals (atrial mechanical sensing markers) and the lack of long-term experience to date, data on these aspects will also be collected and analyzed.\n\nThis is a single-center, prospective and retrospective registry that includes all patients receiving a leadless pacing device, as well as all patients who received a leadless pacing device between January 2021 and the start of the registry. All patients undergoing implantation of a leadless pacemaker will be invited to participate in the registry. For patients to be included retrospectively, participation in the registry will be offered at the time of their next routine follow-up visit.\n\nThe indication for leadless pacing will be determined by the physician responsible for the patient. Enrollment in the registry will in no case alter or influence the treatment the patient receives. Data collection will take place at the time of implantation and continuously during follow-up over the entire study period. Pacemaker-related data may be obtained either in person or via remote monitoring.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of adult patients undergoing implantation of a leadless pacemaker at University Hospital St. Pölten, as well as patients who previously received a leadless pacemaker at the same institution since June 2015. Both prospective and retrospective patients are included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing implantation of a leadless pacemaker at the University Hospital of St. Pölten\n* Patients who previously received a leadless pacemaker between June 2015 and the start of the registry (retrospective inclusion).\n* Age ≥ 18 years.\n* Written informed consent provided by the patient.\n\nExclusion Criteria:\n\n* Patients who decline or are unable to provide informed consent.\n* Patients in whom a conventional transvenous pacemaker is implanted (i.e., not leadless).\n* Any condition that, in the opinion of the treating physician, precludes participation in the registry.'}, 'identificationModule': {'nctId': 'NCT07246135', 'acronym': 'LPR', 'briefTitle': 'Leadless Pacemaker Registry: Outcomes and Follow-up From the University Hospital of St. Pölten', 'organization': {'class': 'OTHER', 'fullName': 'Karl Landsteiner University of Health Sciences'}, 'officialTitle': 'Leadless Pacemaker Registry', 'orgStudyIdInfo': {'id': 'GS3-EK-4/899-2024'}}, 'contactsLocationsModule': {'locations': [{'zip': '3100', 'city': 'Sankt Pölten', 'state': 'Lower Austria', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Department of Internal Medicine III', 'role': 'CONTACT', 'email': 'interne3@stpoelten.lknoe.at', 'phone': '+432742900412541'}], 'facility': 'University Hospital of St. Pölten', 'geoPoint': {'lat': 48.20762, 'lon': 15.63725}}], 'centralContacts': [{'name': 'Matthias Granner, MD', 'role': 'CONTACT', 'email': 'matthias.granner@stpoelten.lknoe.at', 'phone': '+432742900422632'}, {'name': 'Department of Internal Medicine III', 'role': 'CONTACT', 'email': 'interne3@stpolten.lknoe.at', 'phone': '+432742900412541'}], 'overallOfficials': [{'name': 'Julia Mascherbauer, MD, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Internal Medicine III, University Hospital of St. Pölten'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karl Landsteiner University of Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital St. Polten', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}