Trials / Unknown
UnknownNCT03118440
Zero-fluoroscopic Navigation Versus Conventional Fluoroscopic Navigation for Single-chamber Pacemaker Implantation
Multi-center, Randomized, Controlled Trial to Compare Feasibility, Safety and Efficacy of Zero-Fluoroscopic Navigation With Conventional Fluoroscopic Navigation for Single-chamber Pacemaker Implantation
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Tongji Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
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 single-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.
Conditions
- Sick Sinus Syndrome
- Complete Atrioventricular Block
- High Degree Second Degree Atrioventricular Block
- Bradycardia
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | zero-fluoroscopy 3D navigation | Pacemaker implantation will be performed without fluoroscopy using 3D navigation systems. |
| PROCEDURE | conventional x-ray navigation | Pacemaker implantation will be performed with fluoroscopy using conventional X-ray navigation. |
Timeline
- Start date
- 2013-01-01
- Primary completion
- 2018-12-01
- Completion
- 2020-12-01
- First posted
- 2017-04-18
- Last updated
- 2017-04-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03118440. Inclusion in this directory is not an endorsement.