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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 : Unknown
Verified April 2017 by Yan Wang, Tongji Hospital.
Recruitment status was:  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 Provincial People's Hospital
Wuhan Asia Heart Hospital
Shenzhen Sun Yat-sen Cardiovascular Hospital
Ningbo No. 1 Hospital
Information provided by (Responsible Party):
Yan Wang, Tongji Hospital

Tracking Information
First Submitted Date  ICMJE April 13, 2017
First Posted Date  ICMJE April 18, 2017
Last Update Posted Date April 18, 2017
Study Start Date  ICMJE January 2013
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2017)
Success rate [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2017)
  • Total procedure time [ Time Frame: during procedure ]
  • Fluoroscopy time [ Time Frame: during procedure ]
  • Complications [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Zero-fluoroscopic Navigation Versus Conventional Fluoroscopic Navigation for Single-chamber Pacemaker Implantation
Official Title  ICMJE Multi-center, Randomized, Controlled Trial to Compare Feasibility, Safety and Efficacy of Zero-Fluoroscopic Navigation With Conventional Fluoroscopic Navigation for Single-chamber Pacemaker Implantation
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Sick Sinus Syndrome
  • Complete Atrioventricular Block
  • High Degree Second Degree Atrioventricular Block
  • Bradycardia
Intervention  ICMJE
  • Procedure: zero-fluoroscopy 3D navigation
    Pacemaker implantation will be performed without fluoroscopy using 3D navigation systems.
    Other Name: non-fluoroscopy 3D navigation
  • Procedure: conventional x-ray navigation
    Pacemaker implantation will be performed with fluoroscopy using conventional X-ray navigation.
    Other Name: fluoroscopy navigation
Study Arms  ICMJE
  • Experimental: Zero-fluoroscopy implantation
    Pacemaker implantation performed for all patients in this group with zero-fluoroscopy 3D navigation.
    Intervention: Procedure: zero-fluoroscopy 3D navigation
  • Active Comparator: Conventional fluoroscopy implantation
    Pacemaker implantation performed for all patients with conventional x-ray navigation.
    Intervention: Procedure: conventional x-ray navigation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 13, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03118440
Other Study ID Numbers  ICMJE TJHCDC-ZF-PMSC-20130101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yan Wang, Tongji Hospital
Study Sponsor  ICMJE Tongji Hospital
Collaborators  ICMJE
  • Fu Wai Hospital, Beijing, China
  • Xinyang Central Hospital
  • First Affiliated Hospital of Guangxi Medical University
  • Guangdong Provincial People's Hospital
  • Wuhan Asia Heart Hospital
  • Shenzhen Sun Yat-sen Cardiovascular Hospital
  • Ningbo No. 1 Hospital
Investigators  ICMJE
Principal Investigator: Yan Wang, PhD Tongji Hospital
PRS Account Tongji Hospital
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP