Three Dimensional Navigation IntraCardiac Guidance Kit for Atrial Septal Puncture

Atrial Fibrillation Clinical Trial

Official title:

A Prospective, Multicenter, Randomized, Controlled Trial to Evaluate the Safety and Efficacy of a Three Dimensional Navigation Intracardiac Guidance Kit for Atrial Septal Puncture

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06188351
• Other study ID #: 3DASP study
• Status: Recruiting
• Phase: N/A
• Start date: April 24, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: December 2023
• Source: Tongji Hospital
• Contact: Yan Wang, PhD
• Phone: +86-13697326307
• Email: newswangyan[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: September 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Diagnosed with atrial fibrillation.

2. Requiring catheter ablation therapy.

3. Voluntarily sign the informed consent.

Exclusion Criteria:

1. Previous atrial septal puncture.

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) ?-?.

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Tongji Hospital	Wuhan Greenrhythm Medical Technology Co., LTD

Country where clinical trial is conducted

China, 

References & Publications (13)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	(Incidence (%) and frequency (number of events) of (serious) adverse events	(Incidence (%) and frequency (number of events) of (serious) adverse events.	one day
Other	Incidence (%) and frequency (number of events) of device-related (serious) adverse events	Incidence (%) and frequency (number of events) of device-related (serious) adverse events.	one day
Other	Incidence of device defects and number of events that occurred	Incidence of device defects and number of events that occurred.	one day
Primary	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
Primary	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	First puncture success rate of atrial septum	When the first septal puncture is performed, the puncture sheath is passed through the septal puncture from the right atrium into the left atrium.	one day
Secondary	Atrial septal puncture duration	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.	one day
Secondary	Total operation time	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).	one day
Secondary	Performance evaluation of a three-dimensional positioning intracardiac guidance kit	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.	one day