Sick Sinus SyndromeZF-PMSCNCT03118440
Zero-fluoroscopic Navigation Versus Conventional Fluoroscopic Navigation for Single-chamber Pacemaker Implantation
A study testing zero-fluoroscopy 3D navigation and conventional x-ray navigation in people with Sick Sinus Syndrome and Complete Atrioventricular Block, run by Tongji Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sick Sinus Syndrome, Complete Atrioventricular Block, High Degree Second Degree Atrioventricular Block
- What is being tested?
- zero-fluoroscopy 3D navigation and conventional x-ray navigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sick Sinus Syndrome
- complete Atrioventricular Block
- high degree second Degree Atrioventricular Block
- Bradycardia
Who cannot join
- pacemaker replacement
- severe structural l cardiac malformations
- severe cardiac enlargement
- venous malformations
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430000
Yan Wang, PhD, 86-13697326307, newswangyan@126.com
Guangzhi Chen, PhD, 86-027-83662842, chengz2003@163.com
About this study
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
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.
Read the 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.
- Conditions
- Sick Sinus Syndrome, Complete Atrioventricular Block, High Degree Second Degree Atrioventricular Block, Bradycardia
- Being tested
- zero-fluoroscopy 3D navigation, conventional x-ray navigation
- Keywords
- Fluoroscopy, Pacemaker, Three dimensional, Radiation, Imaging
- Medical subject headings
- Sick Sinus Syndrome, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zero-fluoroscopy 3D navigationProcedure or surgery
Also called non-fluoroscopy 3D navigation
Pacemaker implantation will be performed without fluoroscopy using 3D navigation systems.
conventional x-ray navigationProcedure or surgery
Also called fluoroscopy navigation
Pacemaker implantation will be performed with fluoroscopy using conventional X-ray navigation.
| Study group | Role | What they receive |
|---|---|---|
| Zero-fluoroscopy implantation | Experimental | Pacemaker implantation performed for all patients in this group with zero-fluoroscopy 3D navigation. Receives: Procedure: zero-fluoroscopy 3D navigation |
| Conventional fluoroscopy implantation | Active comparator | Pacemaker implantation performed for all patients with conventional x-ray navigation. Receives: Procedure: conventional x-ray navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
Measured: 3 months
Secondary outcomes (3)
Total procedure time
Measured: during procedure
Fluoroscopy time
Measured: during procedure
Complications
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study startJan 2013
- Primary completionDec 2018 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Sick Sinus SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Yan Wang, Tongji Hospital
- Investigators
- Yan Wang, PhD, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118440
- Sponsor's protocol ID
- TJHCDC-ZF-PMSC-20130101
- Acronym
- ZF-PMSC
- Status last verified
- Apr 2017
- First submitted
- 13 Apr 2017
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Miller DL, Balter S, Schueler BA, Wagner LK, Strauss KJ, Vano E. Clinical radiation management for fluoroscopically guided interventional procedures. Radiology. 2010 Nov;257(2):321-32. doi: 10.1148/radiol.10091269.
PubMed 20959547Ventura R, Rostock T, Klemm HU, Lutomsky B, Demir C, Weiss C, Meinertz T, Willems S. Catheter ablation of common-type atrial flutter guided by three-dimensional right atrial geometry reconstruction and catheter tracking using cutaneous patches: a randomized prospective study. J Cardiovasc Electrophysiol. 2004 Oct;15(10):1157-61. doi: 10.1046/j.1540-8167.2004.04064.x.
PubMed 15485440Gepstein 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.
PubMed 9118532Lemery R. Interventional electrophysiology at the crossroads: cardiac mapping, ablation and pacing without fluoroscopy. J Cardiovasc Electrophysiol. 2012 Oct;23(10):1087-91. doi: 10.1111/j.1540-8167.2012.02373.x. Epub 2012 Aug 6. No abstract available.
PubMed 22882722Richter 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.
PubMed 24002003Wittkampf 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.
PubMed 10077514Schreieck 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.
PubMed 12520670
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03118440
- Acronym / sponsor ID
- ZF-PMSC / TJHCDC-ZF-PMSC-20130101
- Conditions
- Sick Sinus Syndrome, Complete Atrioventricular Block, High Degree Second Degree Atrioventricular Block, Bradycardia
- Keywords
- Fluoroscopy, Pacemaker, Three dimensional, Radiation, Imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- 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
- Study start
- Jan 2013
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 18 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zero-fluoroscopy implantation | Experimental | Procedure: zero-fluoroscopy 3D navigationPacemaker implantation performed for all patients in this group with zero-fluoroscopy 3D navigation. |
| Conventional fluoroscopy implantation | Active comparator | Procedure: conventional x-ray navigationPacemaker implantation performed for all patients with conventional x-ray navigation. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sick Sinus Syndrome
- complete Atrioventricular Block
- high degree second Degree Atrioventricular Block
- Bradycardia
Key exclusion criteria (4 listed)
- pacemaker replacement
- severe structural l cardiac malformations
- severe cardiac enlargement
- venous malformations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zero-fluoroscopy 3D navigationAlso: non-fluoroscopy 3D navigationPacemaker implantation will be performed without fluoroscopy using 3D navigation systems. | Procedure or surgery | Zero-fluoroscopy implantation |
| conventional x-ray navigationAlso: fluoroscopy navigationPacemaker implantation will be performed with fluoroscopy using conventional X-ray navigation. | Procedure or surgery | Conventional fluoroscopy implantation |
Primary outcome
Success rate
Time frame: 3 months
3 secondary outcomes
Total procedure time
Time frame: during procedure
Fluoroscopy time
Time frame: during procedure
Complications
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
- Background: PubMed 20959547Miller DL, Balter S, Schueler BA, Wagner LK, Strauss KJ, Vano E. Clinical radiation management for fluoroscopically guided interventional procedures. Radiology. 2010 Nov;257(2):321-32. doi: 10.1148/radiol.10091269.
- Background: PubMed 15485440Ventura R, Rostock T, Klemm HU, Lutomsky B, Demir C, Weiss C, Meinertz T, Willems S. Catheter ablation of common-type atrial flutter guided by three-dimensional right atrial geometry reconstruction and catheter tracking using cutaneous patches: a randomized prospective study. J Cardiovasc Electrophysiol. 2004 Oct;15(10):1157-61. doi: 10.1046/j.1540-8167.2004.04064.x.
- Background: PubMed 9118532Gepstein 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.
- Background: PubMed 22882722Lemery R. Interventional electrophysiology at the crossroads: cardiac mapping, ablation and pacing without fluoroscopy. J Cardiovasc Electrophysiol. 2012 Oct;23(10):1087-91. doi: 10.1111/j.1540-8167.2012.02373.x. Epub 2012 Aug 6. No abstract available.
- Background: PubMed 24002003Richter 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.
- Background: PubMed 10077514Wittkampf 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.
- Background: PubMed 12520670Schreieck 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Wang, PhD principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing zero-fluoroscopy 3D navigation and conventional x-ray navigation in people with Sick Sinus Syndrome and Complete Atrioventricular Block, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Wang, PhD (86-027-83663280, newswangyan@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03118440, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2017.