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Zero-fluoroscopic Navigation Versus Conventional Fluoroscopic Navigation for Single-chamber Pacemaker Implantation (ZF-PMSC)

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ClinicalTrials.gov Identifier: NCT03118440
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : April 18, 2017
Sponsor:
Collaborators:
Fu Wai Hospital, Beijing, China
Xinyang Central Hospital
First Affiliated Hospital of Guangxi Medical University
Guangdong General Hospital
Wuhan Asia Heart Hospital
Shenzhen Sun Yat-sen Cardiovascular Hospital
Ningbo No. 1 Hospital
Information provided by (Responsible Party):
Yan Wang, Tongji Hospital

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 single-chamber pacemaker implantation.

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

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: X-Rays
Drug Information available for: X-Rays

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Success rate [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Total procedure time [ Time Frame: during procedure ]
  2. Fluoroscopy time [ Time Frame: during procedure ]
  3. Complications [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sick Sinus Syndrome
  • complete Atrioventricular Block
  • high degree second Degree Atrioventricular Block
  • Bradycardia

Exclusion Criteria:

  • pacemaker replacement
  • severe structural l cardiac malformations
  • severe cardiac enlargement
  • venous malformations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118440


Contacts
Contact: Yan Wang, PhD 86-027-83663280 newswangyan@tjh.tjmu.edu.cn
Contact: Guangzhi Chen, PhD 86-027-83662842 chengz2003@163.com

Locations
China, Hubei
Tongji Hospital Recruiting
Wuhan, Hubei, China, 430000
Contact: Yan Wang, PhD    86-13697326307    newswangyan@126.com   
Contact: Guangzhi Chen, PhD    86-027-83662842    chengz2003@163.com   
Sponsors and Collaborators
Tongji Hospital
Fu Wai Hospital, Beijing, China
Xinyang Central Hospital
First Affiliated Hospital of Guangxi Medical University
Guangdong General Hospital
Wuhan Asia Heart Hospital
Shenzhen Sun Yat-sen Cardiovascular Hospital
Ningbo No. 1 Hospital
Investigators
Principal Investigator: Yan Wang, PhD Tongji Hospital

Publications:

Responsible Party: Yan Wang, Professor, Tongji Hospital
ClinicalTrials.gov Identifier: NCT03118440     History of Changes
Other Study ID Numbers: TJHCDC-ZF-PMSC-20130101
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yan Wang, Tongji Hospital:
Fluoroscopy
Pacemaker
Three dimensional
Radiation
Imaging

Additional relevant MeSH terms:
Bradycardia
Sick Sinus Syndrome
Atrioventricular Block
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arrhythmia, Sinus
Heart Block