Zero-fluoroscopic Navigation Versus Conventional Fluoroscopic Navigation for Single-chamber Pacemaker Implantation (ZF-PMSC)
Primary Purpose
Sick Sinus Syndrome, Complete Atrioventricular Block, High Degree Second Degree Atrioventricular Block
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
zero-fluoroscopy 3D navigation
conventional x-ray navigation
Sponsored by
About this trial
This is an interventional treatment trial for Sick Sinus Syndrome focused on measuring Fluoroscopy, Pacemaker, Three dimensional, Radiation, Imaging
Eligibility 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
Sites / Locations
- Tongji HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Zero-fluoroscopy implantation
Conventional fluoroscopy implantation
Arm Description
Pacemaker implantation performed for all patients in this group with zero-fluoroscopy 3D navigation.
Pacemaker implantation performed for all patients with conventional x-ray navigation.
Outcomes
Primary Outcome Measures
Success rate
Secondary Outcome Measures
Total procedure time
Fluoroscopy time
Complications
Full Information
NCT ID
NCT03118440
First Posted
April 13, 2017
Last Updated
April 13, 2017
Sponsor
Tongji Hospital
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
1. Study Identification
Unique Protocol Identification Number
NCT03118440
Brief Title
Zero-fluoroscopic Navigation Versus Conventional Fluoroscopic Navigation for Single-chamber Pacemaker Implantation
Acronym
ZF-PMSC
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 Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital
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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sick Sinus Syndrome, Complete Atrioventricular Block, High Degree Second Degree Atrioventricular Block, Bradycardia
Keywords
Fluoroscopy, Pacemaker, Three dimensional, Radiation, Imaging
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Zero-fluoroscopy implantation
Arm Type
Experimental
Arm Description
Pacemaker implantation performed for all patients in this group with zero-fluoroscopy 3D navigation.
Arm Title
Conventional fluoroscopy implantation
Arm Type
Active Comparator
Arm Description
Pacemaker implantation performed for all patients with conventional x-ray navigation.
Intervention Type
Procedure
Intervention Name(s)
zero-fluoroscopy 3D navigation
Other Intervention Name(s)
non-fluoroscopy 3D navigation
Intervention Description
Pacemaker implantation will be performed without fluoroscopy using 3D navigation systems.
Intervention Type
Procedure
Intervention Name(s)
conventional x-ray navigation
Other Intervention Name(s)
fluoroscopy navigation
Intervention Description
Pacemaker implantation will be performed with fluoroscopy using conventional X-ray navigation.
Primary Outcome Measure Information:
Title
Success rate
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Total procedure time
Time Frame
during procedure
Title
Fluoroscopy time
Time Frame
during procedure
Title
Complications
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Wang, PhD
Phone
86-027-83663280
Email
newswangyan@tjh.tjmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Guangzhi Chen, PhD
Phone
86-027-83662842
Email
chengz2003@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Wang, PhD
Organizational Affiliation
Tongji Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Wang, PhD
Phone
86-13697326307
Email
newswangyan@126.com
First Name & Middle Initial & Last Name & Degree
Guangzhi Chen, PhD
Phone
86-027-83662842
Email
chengz2003@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20959547
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
9118532
Citation
Gepstein L, Hayam G, Ben-Haim SA. A novel method for nonfluoroscopic catheter-based electroanatomical mapping of the heart. In vitro and in vivo accuracy results. Circulation. 1997 Mar 18;95(6):1611-22. doi: 10.1161/01.cir.95.6.1611.
Results Reference
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PubMed Identifier
22882722
Citation
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Results Reference
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PubMed Identifier
24002003
Citation
Richter S, Doring M, Gaspar T, John S, Rolf S, Sommer P, Hindricks G, Piorkowski C. Cardiac resynchronization therapy device implantation using a new sensor-based navigation system: results from the first human use study. Circ Arrhythm Electrophysiol. 2013 Oct;6(5):917-23. doi: 10.1161/CIRCEP.113.000066. Epub 2013 Sep 3.
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PubMed Identifier
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Citation
Wittkampf FH, Wever EF, Derksen R, Wilde AA, Ramanna H, Hauer RN, Robles de Medina EO. LocaLisa: new technique for real-time 3-dimensional localization of regular intracardiac electrodes. Circulation. 1999 Mar 16;99(10):1312-7. doi: 10.1161/01.cir.99.10.1312.
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PubMed Identifier
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Citation
Schreieck J, Ndrepepa G, Zrenner B, Schneider MA, Weyerbrock S, Dong J, Schmitt C. Radiofrequency ablation of cardiac arrhythmias using a three-dimensional real-time position management and mapping system. Pacing Clin Electrophysiol. 2002 Dec;25(12):1699-707. doi: 10.1046/j.1460-9592.2002.01699.x.
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Zero-fluoroscopic Navigation Versus Conventional Fluoroscopic Navigation for Single-chamber Pacemaker Implantation
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