Three Dimensional Navigation IntraCardiac Guidance Kit for Atrial Septal Puncture
NCT ID: NCT06188351
Last Updated: 2024-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
136 participants
INTERVENTIONAL
2023-04-24
2024-09-01
Brief Summary
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Detailed Description
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This 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Three-Dimensional Navigation Atrial Septal Puncture
Atrial septal puncture will be performed using a three-dimensional navigation intracardiac guidance kit
Three-Dimensional Navigation Atrial Septal Puncture
Atrial septal puncture will be performed using a three-dimensional navigation intracardiac guidance kit
Conventional Atrial Septal Puncture
Atrial septal puncture will be performed using trational atrial septal puncture kit using traditional method.
Conventional Atrial Septal Puncture
Atrial septal puncture will be performed using traditioanl two-dimensional atrial septal puncture kit using traditional method.
Interventions
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Three-Dimensional Navigation Atrial Septal Puncture
Atrial septal puncture will be performed using a three-dimensional navigation intracardiac guidance kit
Conventional Atrial Septal Puncture
Atrial septal puncture will be performed using traditioanl two-dimensional atrial septal puncture kit using traditional method.
Eligibility Criteria
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Inclusion Criteria
2. Requiring catheter ablation therapy.
3. Voluntarily sign the informed consent.
Exclusion Criteria
2. Blood clots in the left atrium or left atrial appendage
3. Left atrial mucinous tumor.
4. Atrial septal defect, including previous surgical correction or interventional occlusion.
5. Acute or severe systemic infection.
6. Cardiac function (NYHA classification) Ⅲ-Ⅳ.
7. Contraindications to anticoagulation.
8. Left ventricular ejection fraction \<35%.
9. Patients with untreated or uncontrolled hyperthyroidism or hypothyroidism.
10. Patients with malignancy with expected survival of less than 1 year.
11. Myocardial infarction or any cardiac intervention or open procedure within the last 3 months
12. Stroke and other cerebrovascular disease or thromboembolic disease within the last 3 months.
13. Participated in clinical trials of other drugs or devices in the past 3 months.
14. Any other condition that the investigator deems inappropriate for participation in this trial.
18 Years
75 Years
ALL
No
Sponsors
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Wuhan Greenrhythm Medical Technology Co., LTD
INDUSTRY
Tongji Hospital
OTHER
Responsible Party
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Yan Wang
Professor
Principal Investigators
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Yan Wang, PhD
Role: PRINCIPAL_INVESTIGATOR
Tongji Hospital Wuhan, Hubei China
Locations
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Tongji Hospital
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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3DASP study
Identifier Type: -
Identifier Source: org_study_id
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