Zero-fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for the Treatment of Ventricular Arrhythmias (ZFOVA)

• ClinicalTrials.gov Identifier: NCT03041519
• Recruitment Status: Unknown
• First Posted: February 2, 2017
• Last Update Posted: February 2, 2017
• Sponsor: Tongji Hospital
• Collaborators: Fu Wai Hospital, Beijing, China; Xinyang Central Hospital; Ningbo No. 1 Hospital; Shanghai Tongji Hospital, Tongji University School of Medicine; Guangxi Medical University
• Information provided by (Responsible Party): Yan Wang, Tongji Hospital

Tracking Information

• First Submitted Date: January 29, 2017
• First Posted Date: February 2, 2017
• Last Update Posted Date: February 2, 2017
• Study Start Date: October 2011
• Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 31, 2017): Procedural success rates [ Time Frame: 3 months ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: January 31, 2017)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Zero-fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for the Treatment of Ventricular Arrhythmias
• 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.
• Brief Summary: This study is intended to compare the feasibility, safety and efficacy of a zero-fluoroscopy approach using Ensite NavX as the only imaging modality with conventional fluoroscopic approach for the catheter ablation of idiopathic ventricular arrhythmias; conventional fluoroscopic approach use fluoroscopy plus Ensite NavX or plus Carto as the imaging modality.
• Detailed Description: Catheter ablation is a well-established treatment to treat patients with a wide range of heart rhythm disturbances. Fluoroscopy is a imaging modality routinely used for the ablation of arrhythmias.Due to the rising concern regarding the harmful effects of radiation exposure to both the patients and operation staffs; three-dimensional mapping systems, including CARTO and Ensite NavX, have been developed and implemented in electrophysiological procedure for the navigation of catheters inside the heart chambers. Ensite NavX system can be used for zero-fluoroscopy approach for catheter ablation of arrhythmias. This study is intended to compare the feasibility, safety and efficacy of a zero-fluoroscopy approach using Ensite NavX as the only imaging modality with conventional fluoroscopic approach for the catheter ablation of idiopathic ventricular arrhythmias; conventional fluoroscopic approach use fluoroscopy plus Ensite NavX or plus Carto as the imaging modality.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment

Condition

• Ventricular Arrythmia
• Ventricular Premature Complexes
• Ventricular Tachycardia

Intervention

• Procedure: Zero-fluoroscopy ablation
  Catheter ablation will be performed under the guidance of Ensite NavX and without fluoroscopy.
• Procedure: Conventional fluoroscopy ablation
  Catheter ablation will be performed under the guidance of fluoroscopy pllus Ensite NavX.

Study Arms

• 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.
  Intervention: Procedure: Zero-fluoroscopy ablation
• Active Comparator: Conventional fluoroscopy ablation
  Conventional fluoroscopy ablation will be performed under fluoroscopic guidance plus Ensite NavX for mapping and ablation during the procedure.
  Intervention: Procedure: Conventional fluoroscopy ablation

Publications *

• Andrade JG, Rivard L, Macle L. The past, the present, and the future of cardiac arrhythmia ablation. Can J Cardiol. 2014 Dec;30(12 Suppl):S431-41. doi: 10.1016/j.cjca.2014.07.731. Epub 2014 Jul 24. Review.
• Anselmino M, Sillano D, Casolati D, Ferraris F, Scaglione M, Gaita F. A new electrophysiology era: zero fluoroscopy. J Cardiovasc Med (Hagerstown). 2013 Mar;14(3):221-7. doi: 10.2459/JCM.0b013e3283536555. Review.
• Koźluk E, Gawrysiak M, Piątkowska A, Lodziński P, Kiliszek M, Małkowska S, Zaczek R, Piątkowski R, Opolski G, Kozłowski D. Radiofrequency ablation without the use of fluoroscopy - in what kind of patients is it feasible? Arch Med Sci. 2013 Oct 31;9(5):821-5. doi: 10.5114/aoms.2013.38676. Epub 2013 Nov 5.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 31, 2017): 300
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2018
• Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Ventricular Tachycardia
• Ventricular Premature Complexes

Exclusion Criteria:

• Organic ventricular tachycardia or ventricular premature complexes
• Drug-induced ventricular tachycardia or ventricular premature complexes

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03041519
• Other Study ID Numbers: TJHXXG-ZF-VT-20161220
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Yan Wang, Tongji Hospital
• Study Sponsor: Tongji Hospital

Collaborators

• Fu Wai Hospital, Beijing, China
• Xinyang Central Hospital
• Ningbo No. 1 Hospital
• Shanghai Tongji Hospital, Tongji University School of Medicine
• Guangxi Medical University

Investigators

• Principal Investigator: Yan Wang, PhD; Tongji Hospital

• PRS Account: Tongji Hospital
• Verification Date: January 2017