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A Retrospective Propensity Matched Study comparing:
Catheter ablation is a well-established treatment to treat patients with a wide scope of heart arrhythmias.
The study is an investigator-initiated, retrospective analysis of prospectively collected data. The study population consists of patients with right-sided arrhythmias who underwent zero-fluoroscopy catheter ablation between the years 2016 and 2018 in 3 centers and a propensity score matched patients group of patients who:
Covariates for matching will be:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zero fluoro | Patients in whom Zero fluoroscopy ablation was performed under the guidance of Ensite for mapping and ablation and fluoroscopy will not be used during the procedure. |
| |
| Conventional ablation without 3D | Patients in whom Conventional fluoroscopy ablation was performed under fluoroscopic guidance only. Additional use of Ensite/Carto/Localisa for mapping was not allowed. |
| |
| Conventional ablation with 3D | Patients in whom Conventional fluoroscopy ablation was performed under fluoroscopic and Ensite/Carto guidance and ablation during the procedure. Use of fluoroscopy and additional Ensite/Carto for mapping and ablation was mandatory. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zero fluoroscopy ablation | Procedure | Catheter ablation for the treatment of atrial and ventricular arrhythmia - no fluoroscopy guidance |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procedural success rates | arrhythmia recurrence within 3 months since the index procedure | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total procedure time | total procedure time measured as needle to needle time | during procedure |
| Fluoroscopy time | total fluoroscopy time during procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Zero fluoroscopy group: patients after right atrium/ventricle arrhythmia ablation performed with 3D (Ensite/Carto) guidance but without fluoroscopy guidance
Convectional fluoroscopy group: patients after right atrium/ventricle arrhythmia ablation performed with fluoroscopy guidance but without 3D (Ensite/Carto) guidance
Convectional fluoroscopy group + 3D: patients after right atrium/ventricle arrhythmia ablation performed with fluoroscopy guidance and with 3D (Ensite/Carto) guidance
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maciej Wójcik, MD, PhD | Contact | +48817244151 | m.wojcik@umlub.pl |
| Name | Affiliation | Role |
|---|---|---|
| Maciej Wójcik, MD, PhD | Medical University of Lublin, Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wojewódzki Szpital Specjalistyczn | Recruiting | Biała Podlaska | 21-500 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27639689 | Background | 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. | |
| 28862408 | Background | 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. |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Conventional ablation without 3D | Procedure | Catheter ablation for the treatment of atrial and ventricular arrhythmia - fluoroscopy guidance only. 3D system (Every Ensite/Carto) is not allowed |
|
|
| Conventional ablation with 3D | Procedure | Catheter ablation for the treatment of atrial and ventricular arrhythmia - fluoroscopy guidance + 3D system support (Ensite/Carto) |
|
|
| during procedure |
| Acute procedural success | acute procedural success defined as arhhythia elimination | 10-30 minutes |
| Recurrence rate | arrhythmia recurrence within 6 months since the index procedure | 6 months |
| Acute Complications rate | Procedural Complications procedure | during procedure |
| All Complications rate | Procedural Complications and Complications within 6 months since the index procedure | 6 months |
| The length of stay during the hospitalization | Number of hospital days for ablation procedure from admission to discharge | 1 month |
| Medical University of Lublin | Recruiting | Lublin | 20-091 | Poland |
|
| SP ZOZ Szpital Puławy | Recruiting | Puławy | 24-100 | Poland |
|
| 27354053 | Background | 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. doi: 10.1093/eurheartj/ehw223. Epub 2016 Jun 26. |
| 26462477 | Background | Seizer P, Bucher V, Frische C, Heinzmann D, Gramlich M, Muller 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. |
| 25790320 | Background | 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. |
| 27957146 | Background | 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. |
| 28159569 | Result | Alvarez M, Bertomeu-Gonzalez V, Arcocha MF, Morina P, Tercedor L, Ferrero de Loma A, Pachon M, Garcia A, Pardo M, Datino T, Alonso C, Osca J; investigators of the Spanish Multicenter Registry of Fluoroscopy-free Ablation. Nonfluoroscopic Catheter Ablation. Results From a Prospective Multicenter Registry. Rev Esp Cardiol (Engl Ed). 2017 Sep;70(9):699-705. doi: 10.1016/j.rec.2016.12.040. Epub 2017 Jan 31. English, Spanish. |