Zero-fluoroscopic Navigation Versus Conventional Fluoroscopic Navigation for Double-chamber Pacemaker Implantation

Bradycardia Clinical Trial

— ZF-PMDC  

Official title:

Multi-center, Randomized, Controlled Trial to Compare Feasibility, Safety and Efficacy of Zero-Fluoroscopic Navigation With Conventional Fluoroscopic Navigation for Double-chamber Pacemaker Implantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03118427
• Other study ID #: TJHCDC-ZF-PMDC-20130101
• Status: Recruiting
• Phase: N/A
• First received: April 13, 2017
• Last updated: April 13, 2017
• Start date: January 2013
• Est. completion date: December 2020

Study information

• Verified date: April 2017
• Source: Tongji Hospital
• Contact: Yan Wang, PhD
• Phone: 86-027-83663280
• Email: newswangyan[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is intended to compare the feasibility, safety and efficacy of Ensite-NavX zero-fluoroscopic navigation system to conventional fluoroscopic X-ray approach as to performing double-chamber pacemaker implantation.

Description:

Permanent pacemaker is a well-established treatment to treat patients with a wide range of heart rhythm disturbances.

Fluoroscopy is the imaging modality routinely used for cardiac device implantation and electrophysiological procedures.Due to the rising concern regarding the harmful effects of radiation exposure to both the patients and operation staffs, novel 3D mapping systems have been developed and implemented in electrophysiological procedure for the navigation of catheters inside the heart chambers.

Ensite NavX system can be used for cardiac imaging as a reliable and safe zero-fluoroscopy approach for implantation of single- or dual-chamber permanent pacemaker in patients. Our method offered a choice for some special population of patient in whom radiation exposure need to be avoided or in the extreme circumstances when the X-ray machine is out-of-order.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2020
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Sick Sinus Syndrome

• complete Atrioventricular Block

• high degree second Degree Atrioventricular Block

• Bradycardia

Exclusion Criteria:

• pacemaker replacement

• severe structural cardiac malformations

• severe cardiac enlargement

• venous malformations

Related Conditions & MeSH terms

• Atrioventricular Block
• Bradycardia
• Complete Atrioventricular Block
• High Degree Second Degree Atrioventricular Block (Disorder)
• Sick Sinus Syndrome

Intervention

Procedure:
• zero-fluoroscopy 3D navigation
Pacemaker implantation will be performed without fluoroscopy using 3D navigation systems.
• conventional x-ray navigation
Pacemaker implantation will be performed with fluoroscopy using conventional X-ray navigation.

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (8)

Lead Sponsor	Collaborator
Tongji Hospital	First Affiliated Hospital of Guangxi Medical University, Fu Wai Hospital, Beijing, China, Guangdong General Hospital, Ningbo No. 1 Hospital, Shenzhen Sun Yat-sen Cardiovascular Hospital, Wuhan Asia Heart Hospital, Xinyang Central Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

Gepstein L, Hayam G, Ben-Haim SA. A novel method for nonfluoroscopic catheter-based electroanatomical mapping of the heart. In vitro and in vivo accuracy results. Circulation. 1997 Mar 18;95(6):1611-22. — View Citation

Lemery R. Interventional electrophysiology at the crossroads: cardiac mapping, ablation and pacing without fluoroscopy. J Cardiovasc Electrophysiol. 2012 Oct;23(10):1087-91. doi: 10.1111/j.1540-8167.2012.02373.x. Epub 2012 Aug 6. — View Citation

Miller DL, Balter S, Schueler BA, Wagner LK, Strauss KJ, Vañó E. Clinical radiation management for fluoroscopically guided interventional procedures. Radiology. 2010 Nov;257(2):321-32. doi: 10.1148/radiol.10091269. Review. — View Citation

Richter S, Döring M, Gaspar T, John S, Rolf S, Sommer P, Hindricks G, Piorkowski C. Cardiac resynchronization therapy device implantation using a new sensor-based navigation system: results from the first human use study. Circ Arrhythm Electrophysiol. 2013 Oct;6(5):917-23. doi: 10.1161/CIRCEP.113.000066. Epub 2013 Sep 3. — View Citation

Schreieck J, Ndrepepa G, Zrenner B, Schneider MA, Weyerbrock S, Dong J, Schmitt C. Radiofrequency ablation of cardiac arrhythmias using a three-dimensional real-time position management and mapping system. Pacing Clin Electrophysiol. 2002 Dec;25(12):1699-707. — View Citation

Ventura R, Rostock T, Klemm HU, Lutomsky B, Demir C, Weiss C, Meinertz T, Willems S. Catheter ablation of common-type atrial flutter guided by three-dimensional right atrial geometry reconstruction and catheter tracking using cutaneous patches: a randomized prospective study. J Cardiovasc Electrophysiol. 2004 Oct;15(10):1157-61. — View Citation

Wittkampf FH, Wever EF, Derksen R, Wilde AA, Ramanna H, Hauer RN, Robles de Medina EO. LocaLisa: new technique for real-time 3-dimensional localization of regular intracardiac electrodes. Circulation. 1999 Mar 16;99(10):1312-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate		3 months
Secondary	Total procedure time		during procedure
Secondary	Fluoroscopy time		during procedure
Secondary	Complications		1 year