Ventricular Tachycardia Clinical Trial
— ZFOVAOfficial 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.
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 2018 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Ventricular Tachycardia - Ventricular Premature Complexes Exclusion Criteria: - Organic ventricular tachycardia or ventricular premature complexes - Drug-induced ventricular tachycardia or ventricular premature complexes |
Country | Name | City | State |
---|---|---|---|
China | Tongji Hospital | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Tongji Hospital | Fu Wai Hospital, Beijing, China, Guangxi Medical University, Ningbo No. 1 Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, Xinyang Central Hospital |
China,
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. Review. — View Citation
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. — View Citation
Kozluk E, Gawrysiak M, Piatkowska A, Lodzinski P, Kiliszek M, Malkowska S, Zaczek R, Piatkowski R, Opolski G, Kozlowski 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Procedural success rates | 3 months | ||
Secondary | Total procedure time | during procedure | ||
Secondary | Fluoroscopy time | during procedure | ||
Secondary | Complications | 1 year | ||
Secondary | Immediate success rate | 10~30minutes |
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