Ignite Creation Date:
2025-12-24 @ 1:16 PM
Ignite Modification Date:
2025-12-25 @ 12:24 PM
Study NCT ID:
NCT05817695
Status:
UNKNOWN
Last Update Posted:
2023-04-18
First Post:
2023-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiac Synchronization and Tricuspid Regurgitation With Leadless Pacemaker
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': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2023-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-16', 'studyFirstSubmitDate': '2023-02-16', 'studyFirstSubmitQcDate': '2023-04-16', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The evaluation of cardiac electrical synchrony', 'timeFrame': '1 month', 'description': 'the QRS duration after pacing'}, {'measure': 'The evaluation of cardiac mechanical synchrony', 'timeFrame': '1 month', 'description': '①Synchronization analysis between left and right ventricles: interventricular mechanical delay (IVMD) in millisecond.\n\n②Left ventricle synchrony analysis: septal-to-posterior wall motion delay (SPWMD) in millisecond，left pre-ejection interval(LPEI) in millisecond.'}], 'secondaryOutcomes': [{'measure': 'Age may affect synchronization', 'timeFrame': '1 month', 'description': 'Age in years'}, {'measure': 'BMI may affect synchronization', 'timeFrame': '1 month', 'description': 'BMI in kg/m\\^2'}, {'measure': 'Blood pressure may affect synchronization', 'timeFrame': '1 month', 'description': 'Systolic and diastolic blood pressure in mmHg'}, {'measure': 'The pacemaker sensing may affect synchronization', 'timeFrame': '1 month', 'description': 'pacemaker sensing in millivolt'}, {'measure': 'The pacemaker lead impedance may affect synchronization', 'timeFrame': '1 month', 'description': 'lead impedance in ohm'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Leadless pacing', 'Synchronization'], 'conditions': ['Bradycardia']}, 'descriptionModule': {'briefSummary': 'Comparison of cardiac synchronization and tricuspid regurgitation with or without leadless pacemaker pacing in different site', 'detailedDescription': 'Right ventricular pacing might lead to pacing-induced cardiomyopathy by dyssynchrony and tricuspid regurgitation. Pacing at various sites had different effects on synchrony and tricuspid regurgitation. This study is to observe the effect of leadless pacemaker implantation in different regions on ventricular synchronization and tricuspid regurgitation. Ultrasound and ECG parameter indices are applied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients consent to LP implantation surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\npatients consent to LP implantation surgery\n\nExclusion Criteria:\n\n1. Patients with inferior vena cava thrombus, a cancer thrombus, an abnormal inferior vena cava;\n2. Patients with femoral vein stenosis and tortuosity failed to accommodate the pacemaker delivery system;\n3. Patients with myocardial infarction;\n4. Patients who have been implanted with devices that affect the pacemaker delivery system, such as vena cava filters or tricuspid valve mechanical valves;\n5. cannot understand or are unwilling to give informed consent.'}, 'identificationModule': {'nctId': 'NCT05817695', 'acronym': 'MICRA-SYNK', 'briefTitle': 'Cardiac Synchronization and Tricuspid Regurgitation With Leadless Pacemaker', 'organization': {'class': 'OTHER', 'fullName': "First People's Hospital of Hangzhou"}, 'officialTitle': 'Effect of Different Pacing Sites on Cardiac Synchronization and Tricuspid Regurgitation After Leadless Pacemaker Implantation', 'orgStudyIdInfo': {'id': 'MICRA-SYNK-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Leadless pacemaker', 'type': 'DEVICE', 'description': 'To observe the effect of pacemaker implantation at different sites on cardiac synchronization and tricuspid regurgitation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '310006', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yi zhou XU', 'role': 'CONTACT', 'email': 'mage0311@163.com', 'phone': '+8657156005600'}, {'name': 'Xiao-fei Gao', 'role': 'CONTACT', 'email': 'mage0311@126.com', 'phone': '+8657188952242'}], 'facility': 'Yi zhou XU', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Yi zhou XU', 'role': 'CONTACT', 'email': 'mage0311@163.com', 'phone': '+8657156005600'}], 'overallOfficials': [{'name': 'Yi zhou XU', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "First People's Hospital of Hangzhou"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First People's Hospital of Hangzhou", 'class': 'OTHER'}, 'collaborators': [{'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}