Multi-center, Randomized, Controlled Trial to Compare Feasibility, Safety and Efficacy of Zero-Fluoroscopic Navigation With Conventional Fluoroscopic Navigation for Double-chamber Pacemaker Implantation
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Tongji Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Success rate
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Zero-fluoroscopy implantation
Pacemaker implantation performed for all patients in this group with zero-fluoroscopy 3D navigation.
Intervention: zero-fluoroscopy 3D navigation (Procedure)
Conventional fluoroscopy implantation
Pacemaker implantation performed for all patients with conventional x-ray navigation.
Intervention: conventional x-ray navigation (Procedure)
Outcomes
Primary Outcomes
Success rate
Time Frame: 3 months
Secondary Outcomes
- Total procedure time(during procedure)
- Fluoroscopy time(during procedure)
- Complications(1 year)
Investigators
Yan Wang
Professor
Tongji Hospital