Zero-fluoroscopic Navigation Versus Conventional Fluoroscopic Navigation for Single-chamber Pacemaker Implantation (ZF-PMSC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03118440|
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : April 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Sick Sinus Syndrome Complete Atrioventricular Block High Degree Second Degree Atrioventricular Block Bradycardia||Procedure: zero-fluoroscopy 3D navigation Procedure: conventional x-ray navigation||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Multi-center, Randomized, Controlled Trial to Compare Feasibility, Safety and Efficacy of Zero-Fluoroscopic Navigation With Conventional Fluoroscopic Navigation for Single-chamber Pacemaker Implantation|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2020|
Experimental: Zero-fluoroscopy implantation
Pacemaker implantation performed for all patients in this group with zero-fluoroscopy 3D navigation.
Procedure: zero-fluoroscopy 3D navigation
Pacemaker implantation will be performed without fluoroscopy using 3D navigation systems.
Other Name: non-fluoroscopy 3D navigation
Active Comparator: Conventional fluoroscopy implantation
Pacemaker implantation performed for all patients with conventional x-ray navigation.
Procedure: conventional x-ray navigation
Pacemaker implantation will be performed with fluoroscopy using conventional X-ray navigation.
Other Name: fluoroscopy navigation
- Success rate [ Time Frame: 3 months ]
- Total procedure time [ Time Frame: during procedure ]
- Fluoroscopy time [ Time Frame: during procedure ]
- Complications [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118440
|Contact: Yan Wang, PhDemail@example.com|
|Contact: Guangzhi Chen, PhDfirstname.lastname@example.org|
|Wuhan, Hubei, China, 430000|
|Contact: Yan Wang, PhD 86-13697326307 email@example.com|
|Contact: Guangzhi Chen, PhD 86-027-83662842 firstname.lastname@example.org|
|Principal Investigator:||Yan Wang, PhD||Tongji Hospital|