Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fu Wai Hospital, Beijing, China | OTHER |
| Xinyang Central Hospital | OTHER |
| First Affiliated Hospital of Guangxi Medical University | OTHER |
| Guangdong Provincial People's Hospital |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zero-fluoroscopy implantation | Experimental | Pacemaker implantation performed for all patients in this group with zero-fluoroscopy 3D navigation. |
|
| Conventional fluoroscopy implantation | Active Comparator | Pacemaker implantation performed for all patients with conventional x-ray navigation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zero-fluoroscopy 3D navigation | Procedure | Pacemaker implantation will be performed without fluoroscopy using 3D navigation systems. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success rate | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total procedure time | during procedure | |
| Fluoroscopy time | during procedure | |
| Complications |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Wang, PhD | Contact | 86-027-83663280 | newswangyan@tjh.tjmu.edu.cn | |
| Guangzhi Chen, PhD | Contact | 86-027-83662842 | chengz2003@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yan Wang, PhD | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital | Recruiting | Wuhan | Hubei | 430030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20959547 | Background | 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. | |
| 15485440 | Background | Ventura 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| OTHER |
| Wuhan Asia Heart Hospital | OTHER |
| Shenzhen Sun Yat-sen Cardiovascular Hospital | OTHER |
| Ningbo No. 1 Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
| conventional x-ray navigation | Procedure | Pacemaker implantation will be performed with fluoroscopy using conventional X-ray navigation. |
|
|
| 1 year |
| 9118532 | Background | 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. |
| 22882722 | Background | Lemery 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. |
| 24002003 | Background | 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. |
| 10077514 | Background | 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. |
| 12520670 | Background | 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. |
| ID | Term |
|---|---|
| D012804 | Sick Sinus Syndrome |
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D001146 | Arrhythmia, Sinus |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006327 | Heart Block |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided