Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location contacts
Contact: Yan Wang, PhD 86-027-83663280 newswangyan@tjh.tjmu.edu.cn
Contact: Guangzhi Chen, PhD 86-027-83662842 chengz2003@163.com

Locations
Layout table for location information
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 Provincial People's Hospital
Wuhan Asia Heart Hospital
Shenzhen Sun Yat-sen Cardiovascular Hospital
Ningbo No. 1 Hospital
Investigators
Layout table for investigator information
Principal Investigator: Yan Wang, PhD Tongji Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Yan Wang, Professor, Tongji Hospital
ClinicalTrials.gov Identifier: NCT03118440    
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

Layout table for additional information
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:
Layout table for MeSH terms
Bradycardia
Atrioventricular Block
Sick Sinus Syndrome
Arrhythmias, Cardiac
Heart Diseases
 Cardiovascular Diseases
Pathologic Processes
Heart Block
Cardiac Conduction System Disease
Arrhythmia, Sinus