Zero-fluoroscopic Navigation Versus Conventional Fluoroscopic Navigation for Double-chamber Pacemaker Implantation (ZF-PMDC)

April 13, 2017 updated by: Yan Wang, Tongji Hospital

Multi-center, Randomized, Controlled Trial to Compare Feasibility, Safety and Efficacy of Zero-Fluoroscopic Navigation With Conventional Fluoroscopic Navigation for Double-chamber Pacemaker Implantation

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • fluoroscopy navigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Success rate
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Total procedure time
Time Frame: during procedure
during procedure
Fluoroscopy time
Time Frame: during procedure
during procedure
Complications
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Collaborators

Guangdong Provincial People's Hospital
Wuhan Asia Heart Hospital
Fu Wai Hospital, Beijing, China
Ningbo No. 1 Hospital
First Affiliated Hospital of Guangxi Medical University
Xinyang Central Hospital
Shenzhen Sun Yat-sen Cardiovascular Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

April 13, 2017

First Submitted That Met QC Criteria

April 13, 2017

First Posted (Actual)

April 18, 2017

Study Record Updates

Last Update Posted (Actual)

April 18, 2017

Last Update Submitted That Met QC Criteria

April 13, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJHCDC-ZF-PMDC-20130101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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