Zero-fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for the Treatment of Ventricular Arrhythmias (ZFOVA)
|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: NCT03041519|
Recruitment Status : Unknown
Verified January 2017 by Yan Wang, Tongji Hospital.
Recruitment status was: Recruiting
First Posted : February 2, 2017
Last Update Posted : February 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Ventricular Arrythmia Ventricular Premature Complexes Ventricular Tachycardia||Procedure: Zero-fluoroscopy ablation Procedure: Conventional fluoroscopy ablation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Multi-center, Randomized, Controlled, Prospective Trial to Compare the Feasibility, Safety, and Efficacy of Zero-fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for the Treatment of Ventricular Arrhythmias.|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||December 2018|
Experimental: Zero-fluoroscopy ablation
Zero-fluoroscopy ablation will be performed under the guidance of Ensite NavX for mapping and ablation and fluoroscopy will not be used during the procedure.
Procedure: Zero-fluoroscopy ablation
Catheter ablation will be performed under the guidance of Ensite NavX and without fluoroscopy.
Active Comparator: Conventional fluoroscopy ablation
Conventional fluoroscopy ablation will be performed under fluoroscopic guidance plus Ensite NavX for mapping and ablation during the procedure.
Procedure: Conventional fluoroscopy ablation
Catheter ablation will be performed under the guidance of fluoroscopy pllus Ensite NavX.
- Procedural success rates [ Time Frame: 3 months ]
- Total procedure time [ Time Frame: during procedure ]
- Fluoroscopy time [ Time Frame: during procedure ]
- Complications [ Time Frame: 1 year ]
- Immediate success rate [ Time Frame: 10~30minutes ]
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): NCT03041519
|Contact: Yan Wang, PhDemail@example.com|
|Contact: Guangzhi Chen, PhDfirstname.lastname@example.org|
|Principal Investigator:||Yan Wang, PhD||Tongji Hospital|