Three Dimensional Navigation IntraCardiac Guidance Kit for Atrial Septal Puncture

NCT06188351 | Unknown DMC

• 1 other identifier: 3DASP study
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation

Keywords

Atrial septal puncture; Three dimensional; fluroscopy; Catheter Ablation

Outcome Measures

Primary Outcomes (2)

• Success rate of atrial septal puncture

  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.

  one day

• X-Ray exposure time

  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).

  one day

Secondary Outcomes (4)

• First puncture success rate of atrial septum

  one day

• Atrial septal puncture duration

  one day

• Total operation time

  one day

• Performance evaluation of a three-dimensional positioning intracardiac guidance kit

  one day

Other Outcomes (3)

• （Incidence (%) and frequency (number of events) of (serious) adverse events

  one day

• Incidence (%) and frequency (number of events) of device-related (serious) adverse events

  one day

• Incidence of device defects and number of events that occurred

  one day

Study Arms (2)

Three-Dimensional Navigation Atrial Septal Puncture

EXPERIMENTAL

Atrial septal puncture will be performed using a three-dimensional navigation intracardiac guidance kit

Device: Three-Dimensional Navigation Atrial Septal Puncture

Conventional Atrial Septal Puncture

ACTIVE COMPARATOR

Atrial septal puncture will be performed using trational atrial septal puncture kit using traditional method.

Device: Conventional Atrial Septal Puncture

Interventions

Three-Dimensional Navigation Atrial Septal Puncture DEVICE

Atrial septal puncture will be performed using a three-dimensional navigation intracardiac guidance kit

Three-Dimensional Navigation Atrial Septal Puncture

Conventional Atrial Septal Puncture DEVICE

Atrial septal puncture will be performed using traditioanl two-dimensional atrial septal puncture kit using traditional method.

Conventional Atrial Septal Puncture

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with atrial fibrillation.
• Requiring catheter ablation therapy.
• Voluntarily sign the informed consent.

You may not qualify if:

• Previous atrial septal puncture.
• Blood clots in the left atrium or left atrial appendage
• Left atrial mucinous tumor.
• Atrial septal defect, including previous surgical correction or interventional occlusion.
• Acute or severe systemic infection.
• Cardiac function (NYHA classification) Ⅲ-Ⅳ.
• Contraindications to anticoagulation.
• Left ventricular ejection fraction \<35%.
• Patients with untreated or uncontrolled hyperthyroidism or hypothyroidism.
• Patients with malignancy with expected survival of less than 1 year.
• Myocardial infarction or any cardiac intervention or open procedure within the last 3 months
• Stroke and other cerebrovascular disease or thromboembolic disease within the last 3 months.
• Participated in clinical trials of other drugs or devices in the past 3 months.
• Any other condition that the investigator deems inappropriate for participation in this trial.

Sponsors & Collaborators

• Tongji Hospital: lead
• Wuhan Greenrhythm Medical Technology Co., LTD: collaborator

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (13)

• 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: 32438994 BACKGROUND

• 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: 29250235 BACKGROUND

• 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: 34123417 BACKGROUND

• 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: 21503731 BACKGROUND

• 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: 19808411 BACKGROUND

• 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: 30397922 BACKGROUND

• 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: 26607305 BACKGROUND

• 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: 28969539 BACKGROUND

• 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: 25731834 BACKGROUND

• 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: 33034794 BACKGROUND

• 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: 13649591 BACKGROUND

• 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: 29089313 BACKGROUND

• 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.

  PMID: 29161923 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yan Wang, PhD

  Tongji Hospital Wuhan, Hubei China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Wang, PhD

CONTACT

+86-13697326307; newswangyan@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 19, 2023
• First Posted: January 3, 2024
• Study Start: April 24, 2023
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)