Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT03118427
Study type Interventional
Source Tongji Hospital
Contact Yan Wang, PhD
Phone 86-027-83663280
Email newswangyan@tjh.tjmu.edu.cn
Status Recruiting
Phase N/A
Start date January 2013
Completion date December 2020

See also
  Status Clinical Trial Phase
Completed NCT03922386 - Safety and Electrical Performances of XFINE Leads N/A
Completed NCT03294018 - Heart Rate Changes Following the Administration of Sugammadex
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Not yet recruiting NCT05440071 - PoSt-market Assessment on Safety and Performance of J-sHAPed xFINE Lead
Completed NCT02153242 - The Effects of Selective Site Right Ventricular Pacing
Recruiting NCT01825473 - Study of Erythromycin in GER-Associated Apnea of the Newborn N/A
Completed NCT00950287 - Detection of Neonatal Bradycardia N/A
Completed NCT00721136 - Randomized Study of the Use of Warfarin During Pacemaker or ICD Implantation in Patients Requiring Long Term Anticoagulation N/A
Completed NCT00286858 - Beluga - Clinical Observations of Automatic Algorithms for Cardiac Pacing
Completed NCT00158925 - The EASYTRAK EPI Clinical Investigation Phase 3
Completed NCT00180557 - Austria Study - Analysis of Difference Between Active and Passive Fixation Leads Phase 4
Completed NCT01076348 - Model 4965 Post-Approval Study
Completed NCT04198220 - BIO|STREAM.ICM Obesity
Recruiting NCT05298748 - The Effect of Womb Recordings on Maturation of Respiratory Control in Preterm Infants N/A
Recruiting NCT04353960 - The Alaska Oculocardiac Reflex Study
Terminated NCT04093414 - Left Bundle Area Versus Selective His Bundle Pacing N/A
Completed NCT03786640 - Abbott Brady 3T MRI PMCF
Recruiting NCT05932602 - AVEIR DR Coverage With Evidence Development (CED) Study
Recruiting NCT05935007 - Aveir DR Real-World Evidence Post-Approval Study
Recruiting NCT04075084 - Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)