Arrhythmia Clinical Trial
— ZERO-FluoroOfficial title:
Multi-center, Observational, Retrospective Comparison of the Feasibility, Safety, and Efficacy of Real Zero Fluoroscopy Versus Conventional Fluoroscopic Catheter Ablation With and Without 3D System Support: Propensity Matched Study
NCT number | NCT03458273 |
Other study ID # | MW-MULublin-2 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 10, 2018 |
Est. completion date | December 2018 |
A Retrospective Propensity Matched Study comparing:
- real zero fluoroscopy catheter ablation
- conventional fluoroscopy catheter ablation without 3D system
- conventional fluoroscopy catheter ablation with 3D system
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 2018 |
Est. primary completion date | November 2018 |
Accepts healthy volunteers | |
Gender | All |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: - right atrial tachycardia - right atrial premature complexes - AVNRT - right atrial AVRT/WPW - right ventricle tachycardia / right ventricle premature complexes Exclusion Criteria: - left atrium arrhythmia - left ventricle arrhythmia |
Country | Name | City | State |
---|---|---|---|
Poland | Wojewódzki Szpital Specjalistyczn | Biala Podlaska | |
Poland | Medical University of Lublin | Lublin | |
Poland | SP ZOZ Szpital Pulawy | Pulawy |
Lead Sponsor | Collaborator |
---|---|
Medical University of Lublin |
Poland,
Álvarez M, Bertomeu-González V, Arcocha MF, Moriña P, Tercedor L, Ferrero de Loma Á, Pachón M, García A, Pardo M, Datino T, Alonso C, Osca J; investigators of the Spanish Multicenter Registry of Fluoroscopy-free Ablation. Nonfluoroscopic Catheter Ablation — View Citation
Bulava A, Hanis J, Eisenberger M. Catheter Ablation of Atrial Fibrillation Using Zero-Fluoroscopy Technique: A Randomized Trial. Pacing Clin Electrophysiol. 2015 Jul;38(7):797-806. doi: 10.1111/pace.12634. Epub 2015 Apr 16. — View Citation
Casella M, Ribatti V, Catto V, Vettor G, Fassini G, Biagioli V, Dello Russo A, Tondo C. Benefits of electroanatomic ablation of conventional cardiac arrhytmias: from fluoroscopy to zero X-ray mapping. Minerva Cardioangiol. 2018 Feb;66(1):49-62. doi: 10.23736/S0026-4725.17.04478-4. Epub 2017 Aug 31. Review. — View Citation
Gaita F, Guerra PG, Battaglia A, Anselmino M. The dream of near-zero X-rays ablation comes true. Eur Heart J. 2016 Sep 21;37(36):2749-2755. Epub 2016 Jun 26. Review. — View Citation
Scaglione M, Ebrille E, Clemente FD, Gaita F, Bradfield JS. Catheter Ablation of Atrial Fibrillation Without Radiation Exposure Using A 3D Mapping System. J Atr Fibrillation. 2015 Feb 28;7(5):1167. doi: 10.4022/jafib.1167. eCollection 2015 Feb-Mar. Review. — View Citation
Seizer P, Bucher V, Frische C, Heinzmann D, Gramlich M, Müller I, Henning A, Hofbeck M, Kerst G, Gawaz M, Schreieck J. Efficacy and safety of zero-fluoroscopy ablation for supraventricular tachycardias. Use of optional contact force measurement for zero-fluoroscopy ablation in a clinical routine setting. Herz. 2016 May;41(3):241-5. doi: 10.1007/s00059-015-4358-4. Epub 2015 Oct 13. — View Citation
Yang L, Sun G, Chen X, Chen G, Yang S, Guo P, Wang Y, Wang DW. Meta-Analysis of Zero or Near-Zero Fluoroscopy Use During Ablation of Cardiac Arrhythmias. Am J Cardiol. 2016 Nov 15;118(10):1511-1518. doi: 10.1016/j.amjcard.2016.08.014. Epub 2016 Aug 24. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Procedural success rates | arrhythmia recurrence within 3 months since the index procedure | 3 months | |
Secondary | Total procedure time | total procedure time measured as needle to needle time | during procedure | |
Secondary | Fluoroscopy time | total fluoroscopy time during procedure | during procedure | |
Secondary | Acute procedural success | acute procedural success defined as arhhythia elimination | 10-30 minutes | |
Secondary | Recurrence rate | arrhythmia recurrence within 6 months since the index procedure | 6 months | |
Secondary | Acute Complications rate | Procedural Complications procedure | during procedure | |
Secondary | All Complications rate | Procedural Complications and Complications within 6 months since the index procedure | 6 months | |
Secondary | The length of stay during the hospitalization | Number of hospital days for ablation procedure from admission to discharge | 1 month |
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