Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-27 @ 8:26 AM
Study NCT ID:
NCT04931550
Status:
RECRUITING
Last Update Posted:
2023-01-31
First Post:
2021-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of Impact of Different Pacing Site in Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001919', 'term': 'Bradycardia'}, {'id': 'D006333', 'term': 'Heart Failure'}], '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': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-29', 'studyFirstSubmitDate': '2021-06-14', 'studyFirstSubmitQcDate': '2021-06-14', 'lastUpdatePostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of Cardiovascular death, myocardial infarction, and stroke events', 'timeFrame': '60 months', 'description': 'Composite of Cardiovascular death, myocardial infarction, and stroke events in 60 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bradyarrhythmias', 'Heart Failure', 'Pacemaker']}, 'descriptionModule': {'briefSummary': 'At present, cardiac pacing has been widely used in the treatment of bradyarrhythmias and heart failure, which can effectively improve the survival rate of patients. With the rapid development of technology, different sites can be chosen to pace, such as right atrial appendage, the atrial septum and the right atrial wall in the atrium, His bundle, left bundle branch area, right ventricular apex, outflow tract, and left ventricular pacing via coronary vein in the ventricle. There are few studies comparing the long-term efficacy and safety of different pacing sites in daily practice. This study aims to observe the efficacy and safety of cardiac pacing at different sites in short and long term, and to compare the advantages and disadvantages of pacing at different sites.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "According to the current reports and the researcher's pacing implantation status, with an enrollment rate of 90% and a loss of follow-up rate of 10%, it is estimated that 600 cases were screened, 540 cases were selected, and about 500 cases were effective.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who received pacemaker implantation in the Second Hospital of Zhejiang Medical University by Pan Xiaohong and other surgeons.\n* Patients who have the ability to understand the test and can cooperate with investigators.\n\nExclusion Criteria:\n\n* Patients who unable to understand or unwilling to fill in informed consent forms or follow visitors.'}, 'identificationModule': {'nctId': 'NCT04931550', 'briefTitle': 'Clinical Study of Impact of Different Pacing Site in Patients', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Clinical Study of Impact of Different Pacing Site in Patients', 'orgStudyIdInfo': {'id': 'Y2020-675'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pacemaker implantation', 'type': 'DEVICE', 'description': 'Different pacing sites will be chosen according to the patients condition.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'XiaoHong PAN', 'role': 'CONTACT', 'email': 'heartpanxh@zju.edu.cn', 'phone': '+8613857116993'}], 'facility': '2nd Affiliated Hospital, School of Medicine, Zhejiang University, China', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Xiaohong Pan', 'role': 'CONTACT', 'email': 'heartpanxh@zju.edu.cn', 'phone': '+8613857116993'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}