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

Not Applicable

• Conditions: Sick Sinus Syndrome; Bradycardia; Complete Atrioventricular Block; High Degree Second Degree Atrioventricular Block (Disorder)
• Interventions: Procedure: conventional x-ray navigation; Procedure: zero-fluoroscopy 3D navigation

• Registration Number: NCT03118427
• Lead Sponsor: Tongji Hospital

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.

Study Timeline

• Study Start: 2013-01
• Status Verified: 2017-04
• Study First Submitted: 2017-04-13
• Study First Submitted QC: 2017-04-13
• Last Update Submitted: 2017-04-13
• Study First Posted: 2017-04-18
• Last Update Posted: 2017-04-18
• Primary Completion: 2018-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional fluoroscopy implantation	conventional x-ray navigation	Pacemaker implantation performed for all patients with conventional x-ray navigation.
Zero-fluoroscopy implantation	zero-fluoroscopy 3D navigation	Pacemaker implantation performed for all patients in this group with zero-fluoroscopy 3D navigation.

Primary Outcome Measures

Name	Time	Method
Success rate	3 months

Secondary Outcome Measures

Name	Time	Method
Complications	1 year
Total procedure time	during procedure
Fluoroscopy time	during procedure

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China