Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT06188351
Status:
RECRUITING
Last Update Posted:
2024-01-03
First Post:
2023-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Three Dimensional Navigation IntraCardiac Guidance Kit for Atrial Septal Puncture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 136}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-02', 'studyFirstSubmitDate': '2023-11-19', 'studyFirstSubmitQcDate': '2024-01-02', 'lastUpdatePostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': '（Incidence (%) and frequency (number of events) of (serious) adverse events', 'timeFrame': 'one day', 'description': '（Incidence (%) and frequency (number of events) of (serious) adverse events.'}, {'measure': 'Incidence (%) and frequency (number of events) of device-related (serious) adverse events', 'timeFrame': 'one day', 'description': 'Incidence (%) and frequency (number of events) of device-related (serious) adverse events.'}, {'measure': 'Incidence of device defects and number of events that occurred', 'timeFrame': 'one day', 'description': 'Incidence of device defects and number of events that occurred.'}], 'primaryOutcomes': [{'measure': 'Success rate of atrial septal puncture', 'timeFrame': 'one day', 'description': 'Successful atrial septal puncture is defined as the right and left interatrial pathways are established and the ablation catheter can enter the left atrium smoothly for subsequent ablation operations.'}, {'measure': 'X-Ray exposure time', 'timeFrame': 'one day', 'description': 'X-ray exposure time from the successful femoral vein puncture to the entry of the external sheath into the left atrium (ending with heparin saline flushing of the sheath).'}], 'secondaryOutcomes': [{'measure': 'First puncture success rate of atrial septum', 'timeFrame': 'one day', 'description': 'When the first septal puncture is performed, the puncture sheath is passed through the septal puncture from the right atrium into the left atrium.'}, {'measure': 'Atrial septal puncture duration', 'timeFrame': 'one day', 'description': 'Time taken from the time the puncture needle enters the dilator to the time when heparin saline is applied to flush the sheath after the external sheath enters the left atrium.'}, {'measure': 'Total operation time', 'timeFrame': 'one day', 'description': 'Time taken from the start of successful femoral vein puncture to the entry of the external sheath into the left atrium (ending with heparin saline flushing of the sheath).'}, {'measure': 'Performance evaluation of a three-dimensional positioning intracardiac guidance kit', 'timeFrame': 'one day', 'description': 'The investigators evaluated the products in terms of pushing performance, retraction performance, torsional control performance, bending resistance/kinking resistance in dilator, catheter sheath, and blood; and tracking performance of the guidewire, catheter sheath, and puncture needle in the 3D calibration system, respectively.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atrial septal puncture', 'Three dimensional', 'fluroscopy', 'Catheter Ablation'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '32438994', 'type': 'BACKGROUND', 'citation': 'Yu R, Liu N, Lu J, Zhao X, Hu Y, Zhang J, Xu F, Tang R, Bai R, Akar JG, Dong J, Ma C. 3-Dimensional Transseptal Puncture Based on Electrographic Characteristics of Fossa Ovalis: A Fluoroscopy-Free and Echocardiography-Free Method. JACC Cardiovasc Interv. 2020 May 25;13(10):1223-1232. doi: 10.1016/j.jcin.2020.03.015.'}, {'pmid': '29250235', 'type': 'BACKGROUND', 'citation': "Graham AJ, Honarbakhsh S, O'Brien B, Schilling RJ. A Simplified Trans-Septal Puncture Technique using a Needle Free Approach for Cryoablation of Atrial Fibrillation. J Atr Fibrillation. 2017 Aug 31;10(2):1628. doi: 10.4022/jafib.1628. eCollection 2017 Aug-Sep."}, {'pmid': '34123417', 'type': 'BACKGROUND', 'citation': 'Hang F, Cheng L, Liang Z, Dong R, Wang X, Wang Z, Wang Z, Wu Y. Study on the Curative Effect and Safety of Radiofrequency Catheter Ablation of Paroxysmal Atrial Fibrillation via Zero-Fluoroscopy Transseptal Puncture under the Dual Guidance of Electroanatomical Mapping and Intracardiac Echocardiography. Cardiol Res Pract. 2021 May 24;2021:5561574. doi: 10.1155/2021/5561574. eCollection 2021.'}, {'pmid': '21503731', 'type': 'BACKGROUND', 'citation': "Fromentin S, Sarrazin JF, Champagne J, Nault I, Philippon F, Molin F, Blier L, O'Hara G. Prospective comparison between conventional transseptal puncture and transseptal needle puncture with radiofrequency energy. J Interv Card Electrophysiol. 2011 Sep;31(3):237-42. doi: 10.1007/s10840-011-9564-2. Epub 2011 Apr 19."}, {'pmid': '19808411', 'type': 'BACKGROUND', 'citation': "Knecht S, Jais P, Nault I, Wright M, Matsuo S, Madaffari A, Lellouche N, O'Neill MD, Derval N, Deplagne A, Bordachar P, Sacher F, Hocini M, Clementy J, Haissaguerre M. Radiofrequency puncture of the fossa ovalis for resistant transseptal access. Circ Arrhythm Electrophysiol. 2008 Aug;1(3):169-74. doi: 10.1161/CIRCEP.108.788000. Epub 2008 Jun 23."}, {'pmid': '30397922', 'type': 'BACKGROUND', 'citation': 'Sawhney V, Breitenstein A, Watts T, Garcia J, Finlay M, Lowe M, Hunter R, Earley MJ, Schilling RJ, Sporton S, Dhinoja M. A novel technique for performing transseptal puncture guided by a non-fluoroscopic 3D mapping system. Pacing Clin Electrophysiol. 2019 Jan;42(1):4-12. doi: 10.1111/pace.13541. Epub 2018 Nov 28.'}, {'pmid': '26607305', 'type': 'BACKGROUND', 'citation': 'Koektuerk B, Yorgun H, Koektuerk O, Turan CH, Gorr E, Horlitz M, Turan RG. Rotational Angiography Based Three-Dimensional Left Atrial Reconstruction: A New Approach for Transseptal Puncture. Cardiovasc Ther. 2016 Feb;34(1):49-56. doi: 10.1111/1755-5922.12167.'}, {'pmid': '28969539', 'type': 'BACKGROUND', 'citation': 'Manolis AS. Transseptal Access to the Left Atrium: Tips and Tricks to Keep it Safe Derived from Single Operator Experience and Review of the Literature. Curr Cardiol Rev. 2017;13(4):305-318. doi: 10.2174/1573403X13666170927122036.'}, {'pmid': '25731834', 'type': 'BACKGROUND', 'citation': 'Rodriguez-Manero M, Martinez-Sande JL, Fandino R, Garcia-Seara J, Chierchia GB, Fernandez-Lopez XA, Osorio I, de Alegria AM, Souto-Bayarri M, Brugada P, Gonzalez-Juanatey JR. Fluoroscopic integration of the cardiac computed tomography as a guide for transseptal puncture during atrial fibrillation ablation: A feasibility study. Int J Cardiol. 2015 Apr 1;184:274-275. doi: 10.1016/j.ijcard.2015.02.035. Epub 2015 Feb 24. No abstract available.'}, {'pmid': '33034794', 'type': 'BACKGROUND', 'citation': 'Li C, Zhang J, Li S, Sang C, Liu N, Du X, Dong J, Ma C. A novel and easy approach to difficult transseptal puncture during atrial fibrillation ablation. J Interv Card Electrophysiol. 2021 Nov;62(2):269-276. doi: 10.1007/s10840-020-00891-y. Epub 2020 Oct 9.'}, {'pmid': '13649591', 'type': 'BACKGROUND', 'citation': 'ROSS J Jr, BRAUNWALD E, MORROW AG. Transseptal left atrial puncture; new technique for the measurement of left atrial pressure in man. Am J Cardiol. 1959 May;3(5):653-5. doi: 10.1016/0002-9149(59)90347-9. No abstract available.'}, {'pmid': '29089313', 'type': 'BACKGROUND', 'citation': "Vlastra W, Delewi R, Sjauw KD, Beijk MA, Claessen BE, Streekstra GJ, Bekker RJ, van Hattum JC, Wykrzykowska JJ, Vis MM, Koch KT, de Winter RJ, Piek JJ, Henriques JPS. Efficacy of the RADPAD Protection Drape in Reducing Operators' Radiation Exposure in the Catheterization Laboratory: A Sham-Controlled Randomized Trial. Circ Cardiovasc Interv. 2017 Nov;10(11):e006058. doi: 10.1161/CIRCINTERVENTIONS.117.006058."}, {'pmid': '29161923', 'type': 'BACKGROUND', 'citation': 'Salghetti F, Sieira J, Chierchia GB, Curnis A, de Asmundis C. Recognizing and reacting to complications of trans-septal puncture. Expert Rev Cardiovasc Ther. 2017 Dec;15(12):905-912. doi: 10.1080/14779072.2017.1408411. Epub 2017 Nov 30.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the safety and efficacy of a three-dimensional navigation intracardiac guidance kit to perform atrial septal puncture in patients requiring catheter ablation, which will be compared with procedures using traditional kit for atrial septal puncture.', 'detailedDescription': 'Atrial septal puncture has become a key technique in cardiac interventional procedures. Traditional septal punctures are routinely perfomed under two-dimensioanl guidance, whic are likely to be not acurate sometimes.\n\nThis study is aimed to study the safety and efficacy of a novel designed three-dimensional navigation Intracardiac guidance kit for atrial septal puncture in patients with atrial fibrillation requiring catheter ablation and to explore the possibility of transseptal without fluoroscopy using the three-dimensional positioning intracardiac guidance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed with atrial fibrillation.\n2. Requiring catheter ablation therapy.\n3. Voluntarily sign the informed consent.\n\nExclusion Criteria:\n\n1. Previous atrial septal puncture.\n2. Blood clots in the left atrium or left atrial appendage\n3. Left atrial mucinous tumor.\n4. Atrial septal defect, including previous surgical correction or interventional occlusion.\n5. Acute or severe systemic infection.\n6. Cardiac function (NYHA classification) Ⅲ-Ⅳ.\n7. Contraindications to anticoagulation.\n8. Left ventricular ejection fraction \\<35%.\n9. Patients with untreated or uncontrolled hyperthyroidism or hypothyroidism.\n10. Patients with malignancy with expected survival of less than 1 year.\n11. Myocardial infarction or any cardiac intervention or open procedure within the last 3 months\n12. Stroke and other cerebrovascular disease or thromboembolic disease within the last 3 months.\n13. Participated in clinical trials of other drugs or devices in the past 3 months.\n14. Any other condition that the investigator deems inappropriate for participation in this trial.'}, 'identificationModule': {'nctId': 'NCT06188351', 'briefTitle': 'Three Dimensional Navigation IntraCardiac Guidance Kit for Atrial Septal Puncture', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'A Prospective, Multicenter, Randomized, Controlled Trial to Evaluate the Safety and Efficacy of a Three Dimensional Navigation Intracardiac Guidance Kit for Atrial Septal Puncture', 'orgStudyIdInfo': {'id': '3DASP study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Three-Dimensional Navigation Atrial Septal Puncture', 'description': 'Atrial septal puncture will be performed using a three-dimensional navigation intracardiac guidance kit', 'interventionNames': ['Device: Three-Dimensional Navigation Atrial Septal Puncture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Atrial Septal Puncture', 'description': 'Atrial septal puncture will be performed using trational atrial septal puncture kit using traditional method.', 'interventionNames': ['Device: Conventional Atrial Septal Puncture']}], 'interventions': [{'name': 'Three-Dimensional Navigation Atrial Septal Puncture', 'type': 'DEVICE', 'description': 'Atrial septal puncture will be performed using a three-dimensional navigation intracardiac guidance kit', 'armGroupLabels': ['Three-Dimensional Navigation Atrial Septal Puncture']}, {'name': 'Conventional Atrial Septal Puncture', 'type': 'DEVICE', 'description': 'Atrial septal puncture will be performed using traditioanl two-dimensional atrial septal puncture kit using traditional method.', 'armGroupLabels': ['Conventional Atrial Septal Puncture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yan Wang, PhD', 'role': 'CONTACT', 'email': 'newswangyan@tjh.tjmu.edu.cn', 'phone': '+86-13697326307'}], 'facility': 'Tongji Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Yan Wang, PhD', 'role': 'CONTACT', 'email': 'newswangyan@tjh.tjmu.edu.cn', 'phone': '+86-13697326307'}], 'overallOfficials': [{'name': 'Yan Wang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tongji Hospital Wuhan, Hubei China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wuhan Greenrhythm Medical Technology Co., LTD', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yan Wang', 'investigatorAffiliation': 'Tongji Hospital'}}}}