Zero-fluoroscopic Navigation Versus Conventional Fluoroscopic Navigation for Double-chamber Pacemaker Implantation
ZF-PMDC
Multi-center, Randomized, Controlled Trial to Compare Feasibility, Safety and Efficacy of Zero-Fluoroscopic Navigation With Conventional Fluoroscopic Navigation for Double-chamber Pacemaker Implantation
1 other identifier
interventional
100
1 country
1
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 double-chamber pacemaker implantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 13, 2017
CompletedFirst Posted
Study publicly available on registry
April 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedApril 18, 2017
April 1, 2017
5.9 years
April 13, 2017
April 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Success rate
3 months
Secondary Outcomes (3)
Total procedure time
during procedure
Fluoroscopy time
during procedure
Complications
1 year
Study Arms (2)
Zero-fluoroscopy implantation
EXPERIMENTALPacemaker implantation performed for all patients in this group with zero-fluoroscopy 3D navigation.
Conventional fluoroscopy implantation
ACTIVE COMPARATORPacemaker implantation performed for all patients with conventional x-ray navigation.
Interventions
Pacemaker implantation will be performed without fluoroscopy using 3D navigation systems.
Pacemaker implantation will be performed with fluoroscopy using conventional X-ray navigation.
Eligibility Criteria
You may qualify if:
- Sick Sinus Syndrome
- complete Atrioventricular Block
- high degree second Degree Atrioventricular Block
- Bradycardia
You may not qualify if:
- pacemaker replacement
- severe structural cardiac malformations
- severe cardiac enlargement
- venous malformations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tongji Hospitallead
- Fu Wai Hospital, Beijing, Chinacollaborator
- Xinyang Central Hospitalcollaborator
- First Affiliated Hospital of Guangxi Medical Universitycollaborator
- Guangdong Provincial People's Hospitalcollaborator
- Wuhan Asia Heart Hospitalcollaborator
- Shenzhen Sun Yat-sen Cardiovascular Hospitalcollaborator
- Ningbo No. 1 Hospitalcollaborator
Study Sites (1)
Tongji Hospital
Wuhan, Hubei, 430030, China
Related Publications (7)
Miller DL, Balter S, Schueler BA, Wagner LK, Strauss KJ, Vano E. Clinical radiation management for fluoroscopically guided interventional procedures. Radiology. 2010 Nov;257(2):321-32. doi: 10.1148/radiol.10091269.
PMID: 20959547BACKGROUNDVentura 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. doi: 10.1046/j.1540-8167.2004.04064.x.
PMID: 15485440BACKGROUNDGepstein 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. doi: 10.1161/01.cir.95.6.1611.
PMID: 9118532BACKGROUNDLemery 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. No abstract available.
PMID: 22882722BACKGROUNDRichter S, Doring 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.
PMID: 24002003BACKGROUNDWittkampf 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. doi: 10.1161/01.cir.99.10.1312.
PMID: 10077514BACKGROUNDSchreieck 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. doi: 10.1046/j.1460-9592.2002.01699.x.
PMID: 12520670BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yan Wang, PhD
Tongji Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 13, 2017
First Posted
April 18, 2017
Study Start
January 1, 2013
Primary Completion
December 1, 2018
Study Completion
December 1, 2020
Last Updated
April 18, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share