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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03118427
Acronym
ZF-PMDC
Enrollment
100
Registered
2017-04-18
Start date
2013-01-31
Completion date
2020-12-31
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Fluoroscopy, Pacemaker, Three dimensional, Radiation, Imaging

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.

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.

Interventions

Pacemaker implantation will be performed without fluoroscopy using 3D navigation systems.

Pacemaker implantation will be performed with fluoroscopy using conventional X-ray navigation.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Success rate3 months

Secondary

MeasureTime frame
Total procedure timeduring procedure
Fluoroscopy timeduring procedure
Complications1 year

Countries

China

Contacts

Primary ContactYan Wang, PhD
newswangyan@tjh.tjmu.edu.cn86-027-83663280
Backup ContactGuangzhi Chen, PhD
chengz2003@163.com86-027-83662842

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026