Zero-fluoroscopic Navigation Versus Conventional Fluoroscopic Navigation for Single-chamber Pacemaker Implantation (ZF-PMSC)

• ClinicalTrials.gov Identifier: NCT03118440
• Recruitment Status: Unknown
• First Posted: April 18, 2017
• Last Update Posted: April 18, 2017
• Sponsor: Tongji Hospital
• Collaborators: Fu Wai Hospital, Beijing, China; Xinyang Central Hospital; First Affiliated Hospital of Guangxi Medical University; Guangdong Provincial People's Hospital; Wuhan Asia Heart Hospital; Shenzhen Sun Yat-sen Cardiovascular Hospital; Ningbo No. 1 Hospital
• Information provided by (Responsible Party): Yan Wang, Tongji Hospital

Tracking Information

• First Submitted Date: April 13, 2017
• First Posted Date: April 18, 2017
• Last Update Posted Date: April 18, 2017
• Study Start Date: January 2013
• Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 13, 2017): Success rate [ Time Frame: 3 months ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: April 13, 2017)

• Total procedure time [ Time Frame: during procedure ]
• Fluoroscopy time [ Time Frame: during procedure ]
• Complications [ Time Frame: 1 year ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Zero-fluoroscopic Navigation Versus Conventional Fluoroscopic Navigation for Single-chamber Pacemaker Implantation
• Official Title: Multi-center, Randomized, Controlled Trial to Compare Feasibility, Safety and Efficacy of Zero-Fluoroscopic Navigation With Conventional Fluoroscopic Navigation for Single-chamber Pacemaker Implantation
• Brief 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 single-chamber pacemaker implantation.

Detailed 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment

Condition

• Sick Sinus Syndrome
• Complete Atrioventricular Block
• High Degree Second Degree Atrioventricular Block
• Bradycardia

Intervention

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

Study Arms

• Experimental: Zero-fluoroscopy implantation
  Pacemaker implantation performed for all patients in this group with zero-fluoroscopy 3D navigation.
  Intervention: Procedure: zero-fluoroscopy 3D navigation
• Active Comparator: Conventional fluoroscopy implantation
  Pacemaker implantation performed for all patients with conventional x-ray navigation.
  Intervention: Procedure: conventional x-ray navigation

Publications *

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: April 13, 2017): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2020
• Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Sick Sinus Syndrome
• complete Atrioventricular Block
• high degree second Degree Atrioventricular Block
• Bradycardia

Exclusion Criteria:

• pacemaker replacement
• severe structural l cardiac malformations
• severe cardiac enlargement
• venous malformations

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03118440
• Other Study ID Numbers: TJHCDC-ZF-PMSC-20130101
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Yan Wang, Tongji Hospital
• Study Sponsor: Tongji Hospital

Collaborators

• Fu Wai Hospital, Beijing, China
• Xinyang Central Hospital
• First Affiliated Hospital of Guangxi Medical University
• Guangdong Provincial People's Hospital
• Wuhan Asia Heart Hospital
• Shenzhen Sun Yat-sen Cardiovascular Hospital
• Ningbo No. 1 Hospital

Investigators

• Principal Investigator: Yan Wang, PhD; Tongji Hospital

• PRS Account: Tongji Hospital
• Verification Date: April 2017