Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-25 @ 8:05 PM
Study NCT ID:
NCT05820035
Status:
COMPLETED
Last Update Posted:
2025-05-28
First Post:
2023-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multicenter Study of Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017180', 'term': 'Tachycardia, Ventricular'}, {'id': 'D013611', 'term': 'Tachycardia, Atrioventricular Nodal Reentry'}], 'ancestors': [{'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D054139', 'term': 'Tachycardia, Reciprocating'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective, multicenter, single-arm study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 164}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-23', 'studyFirstSubmitDate': '2023-03-17', 'studyFirstSubmitQcDate': '2023-04-06', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Evaluation of Pulse Ablation equipment', 'timeFrame': 'immediately post ablation', 'description': 'Whether the software can realize each set function, Whether the interface friendly and easy to operate, No abnormal software crash during the operation, et al.'}, {'measure': 'Evaluation of Ablation voltage', 'timeFrame': 'immediately post ablation', 'description': 'Record ablation voltage during ablation'}, {'measure': 'Evaluation of Ablation sites', 'timeFrame': 'immediately post ablation', 'description': 'Record ablation sites during ablation'}, {'measure': 'Evaluation of Ablation x-ray time', 'timeFrame': 'immediately post ablation', 'description': 'Record evaluation of Ablation x-ray time'}], 'primaryOutcomes': [{'measure': 'Primary efficacy and safety endpoints', 'timeFrame': 'at end of the procedure, 1-month follow-up, 3-month follow-up, 6-month follow-up', 'description': 'The primary efficacy endpoints were to evaluate the acute and 6-month follow-up success rate after PFA without the use of antiarrhythmic drugs. The primary safety endpoints were to assess the incidences of SAEs at the end of the procedure and during the 6-month follow-up period.'}], 'secondaryOutcomes': [{'measure': 'Interim analysis', 'timeFrame': 'Refers to the postoperative phase after 6 months.', 'description': 'To assess immediate ablation ablation success at 6 months postoperatively, by Holter in single center.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PFA', 'PSVT', 'AVNRT', 'AVRT'], 'conditions': ['Paroxysmal Supraventricular Tachycardia', 'Atrioventricular Nodal Reentrant Tachycardia', 'Atrioventricular Reciprocating Tachycardia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to explore the safety and efficacy of pulsed field ablation（PFA) in the treatment of paroxysmal pupraventricular pachycardia（PSVT）with a contact force(CF)-sensing PFA Catheter', 'detailedDescription': 'The primary efficacy endpoints were to evaluate the acute and 6-month follow-up success rate after PFA without the use of antiarrhythmic drugs . The primary safety endpoints were to assess the incidences of serious adverse events (SAEs) at the end of the procedure , discharge and during the 6-month follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age from 18 to 80 years,\n2. episode of PSVT recorded by a 12-lead surface electrocardiogram (ECG), 24-hour Holter monitoring, or esophageal electrophysiologic study (EES) before hospitalization\n3. reproducible clinical tachycardia confirmed by the electrophysiological study (EPS).\n\nExclusion Criteria:\n\n1. Previous failure or recurrence of radiofrequency ablation\n2. Left ventricular ejection fraction (LVEF) ≤ 40%\n3. Combined with atrial flutter or atrial fibrillation\n4. Combination of thromboembolic disease\n5. Women who are breastfeeding, pregnant or planning to become pregnant during the study period\n6. Carrying active implants in the body (e.g., pacemakers, ICDs, etc.)\n7. Patients with second-degree (type II) or third-degree atrioventricular block\n8. NYHA Class III-IV cardiac function \\[Appendix 1\\]\n9. Patients with congenital heart disease (excluding atrial septal defect and patent foramen ovale)\n10. Patients with definite acute cerebrovascular disease (including cerebral hemorrhage, stroke, transient ischemic attack) within the last 1 month\n11. cardiovascular events within the last 3 months (including acute myocardial infarction, coronary intervention or heart bypass surgery, prosthetic valve replacement or repair, atrial or ventriculotomy)\n12. Acute or severe systemic infection\n13. Patients with severe liver and kidney diseases, malignant tumors and end-stage diseases\n14. Patients with significant bleeding tendency, hypercoagulable state and serious hematologic disorders\n15. Patients who have participated or are participating in other clinical trials within 3 months before enrollment\n16. Patients who have other conditions that the investigator considers inappropriate for participation in this trial.'}, 'identificationModule': {'nctId': 'NCT05820035', 'acronym': 'PSVT', 'briefTitle': 'A Multicenter Study of Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai MicroPort EP MedTech Co., Ltd.'}, 'officialTitle': 'Focal Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia: A Prospective, Multicenter, Single-Arm Study in Mainland China', 'orgStudyIdInfo': {'id': '775044'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experiment group', 'description': 'Patients of PSVT treated with PFA catheter.', 'interventionNames': ['Device: Pulsed Field Ablation Device and CF-Sensing Pulsed Field Ablation Catheter']}], 'interventions': [{'name': 'Pulsed Field Ablation Device and CF-Sensing Pulsed Field Ablation Catheter', 'type': 'DEVICE', 'description': 'All subjects will be ablated using the pulsed field ablation device and CF-sensing pulsed field ablation catheter in the management of their paroxysmal supraventricular tachycardia', 'armGroupLabels': ['Experiment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '315000', 'city': 'Ningbo', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The First Affiliated Hospital of Ningbo University (original name :Ningbo First Hospital)', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai MicroPort EP MedTech Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}