Zero-fluoroscopic Navigation Versus Conventional Fluoroscopic Navigation for Double-chamber Pacemaker Implantation (ZF-PMDC)

Tongji Hospital

Status: Unknown

Conditions: Bradycardia; High Degree Second Degree Atrioventricular Block (Disorder); Complete Atrioventricular Block; Sick Sinus Syndrome

Treatments: Procedure: zero-fluoroscopy 3D navigation; Procedure: conventional x-ray navigation

Study type: Interventional

Funder types: Other

Identifiers

NCT03118427

TJHCDC-ZF-PMDC-20130101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Zero-fluoroscopy implantation

Experimental group

Description:

Pacemaker implantation performed for all patients in this group with zero-fluoroscopy 3D navigation.

Treatment:

Procedure: zero-fluoroscopy 3D navigation

Conventional fluoroscopy implantation

Active Comparator group

Description:

Pacemaker implantation performed for all patients with conventional x-ray navigation.

Treatment:

Procedure: conventional x-ray navigation