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| Name | Class |
|---|---|
| Azienda Ospedaliero, Universitaria Ospedali Riuniti | OTHER |
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From the literature, the success rate (i.e., absence of AF recurrence) of ablation in cases of paroxysmal AF at one year changes between 70 and 85 percent. This rate is considered suboptimal. Currently there are no data that can assess which factors are predictive of recurrence both clinically and electrophysiologically. In particular, it is not known whether and to what extent the atrial substrate present under baseline conditions affects the success rate of the procedure and what relationships exist with other predictors such as age, sex, atrial size at echo, and duration of arrhythmia.
This is a multicenter prospective and retrospective observational study aimed at examining the role of the left atrial substrate and other baseline clinical variables on the efficacy of transcatheter ablation in patients with paroxysmal atrial fibrillation (AF) who underwent pulmonary vein isolation regardless of the power source and balloon or "point by point" catheters used.
The study will evaluate whether there are baseline clinical or electrophysiological features that can predict the success of transcatheter atrial fibrillation ablation even before it is performed, so as to assess which patients may actually benefit, and which patients should instead undergo more extensive ablative procedures in conjunction with pulmonary vein isolation to achieve an optimal success rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective cohort | Patients with paroxysmal AF with clinical indication to first transcatheter ablation procedure of AF by pulmonary vein isolation |
| |
| Retrospective cohort | Patients who underwent ablative procedure in the two years prior to the start of the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of care | Other | All patients will undergo, as clinically indicated, AF ablation by pulmonary vein isolation achievable by radiofrequency, cryoenergy, or electroporation. All patients will preliminarily undergo electroanatomic mapping of the atrium by CARTO/Navx/Rhythmia system indifferently. Patients will be given follow-up visits at 3-6-12 months, during which any arrhythmic recurrences will be assessed |
| Measure | Description | Time Frame |
|---|---|---|
| Assess clinical and electrophysiological predictors of arrhythmic recurrence | Evaluate the role of atrial disease, assessed by baseline electroanatomic mapping, age, gender, echocardiographic data, years from first AF episode, in predicting AF recurrence after AF ablation. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate acute and mid- to long-term efficacy, safety, and procedural timing of different technologies | Evaluate mid and long term efficacy, safety, procedural timing between Cryo ablation, Pulsed Field Ablation, Radio Frequency ablation, point by point or single shot ablation of paroxysmal atrial fibrillation. | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with paroxysmal AF with clinical indication to first transcatheter ablation procedure of AF by pulmonary vein isolation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefania Riva, MD | Contact | 02 58002584 | stefania.riva@cardiologicomonzino.it | |
| Lorenzo Bianchini, MD | Contact | lorenzo.bianchini@cardiologicomonzino.it |
| Name | Affiliation | Role |
|---|---|---|
| Stefania Riva, MD | IRCCS Centro Cardiologico Monzino | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Universitaria delle Marche | Not yet recruiting | Ancona | 60126 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28506916 | Background | Calkins H, Hindricks G, Cappato R, Kim YH, Saad EB, Aguinaga L, Akar JG, Badhwar V, Brugada J, Camm J, Chen PS, Chen SA, Chung MK, Nielsen JC, Curtis AB, Davies DW, Day JD, d'Avila A, de Groot NMSN, Di Biase L, Duytschaever M, Edgerton JR, Ellenbogen KA, Ellinor PT, Ernst S, Fenelon G, Gerstenfeld EP, Haines DE, Haissaguerre M, Helm RH, Hylek E, Jackman WM, Jalife J, Kalman JM, Kautzner J, Kottkamp H, Kuck KH, Kumagai K, Lee R, Lewalter T, Lindsay BD, Macle L, Mansour M, Marchlinski FE, Michaud GF, Nakagawa H, Natale A, Nattel S, Okumura K, Packer D, Pokushalov E, Reynolds MR, Sanders P, Scanavacca M, Schilling R, Tondo C, Tsao HM, Verma A, Wilber DJ, Yamane T. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2017 Oct;14(10):e275-e444. doi: 10.1016/j.hrthm.2017.05.012. Epub 2017 May 12. No abstract available. | |
| 15653029 |
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|
| Data collection | Other | There's no patient involvement. Data of patients who underwent ablative procedures two years before the start of the study will be retrospectively analyzed |
|
| IRCCS Centro Cardiologico Monzino | Recruiting | Milan | 20138 | Italy |
|
| Background |
| Verma A, Wazni OM, Marrouche NF, Martin DO, Kilicaslan F, Minor S, Schweikert RA, Saliba W, Cummings J, Burkhardt JD, Bhargava M, Belden WA, Abdul-Karim A, Natale A. Pre-existent left atrial scarring in patients undergoing pulmonary vein antrum isolation: an independent predictor of procedural failure. J Am Coll Cardiol. 2005 Jan 18;45(2):285-92. doi: 10.1016/j.jacc.2004.10.035. |
| 25151631 | Background | Rolf S, Kircher S, Arya A, Eitel C, Sommer P, Richter S, Gaspar T, Bollmann A, Altmann D, Piedra C, Hindricks G, Piorkowski C. Tailored atrial substrate modification based on low-voltage areas in catheter ablation of atrial fibrillation. Circ Arrhythm Electrophysiol. 2014 Oct;7(5):825-33. doi: 10.1161/CIRCEP.113.001251. Epub 2014 Aug 23. |
| 34961604 | Background | Tijskens M, Bergonti M, Spera F, Ascione C, Saenen J, Huybrechts W, Miljoen H, Riva S, Wittock A, Heidbuchel H, Tondo C, Sarkozy A. Etiology and Outcome of Catheter Ablation in Patients With Onset of Atrial Fibrillation <45 Years of Age. Am J Cardiol. 2022 Mar 1;166:45-52. doi: 10.1016/j.amjcard.2021.11.030. Epub 2021 Dec 24. |
| 28884923 | Background | Vlachos K, Efremidis M, Letsas KP, Bazoukis G, Martin R, Kalafateli M, Lioni L, Georgopoulos S, Saplaouras A, Efremidis T, Liu T, Valkanas K, Karamichalakis N, Asvestas D, Sideris A. Low-voltage areas detected by high-density electroanatomical mapping predict recurrence after ablation for paroxysmal atrial fibrillation. J Cardiovasc Electrophysiol. 2017 Dec;28(12):1393-1402. doi: 10.1111/jce.13321. Epub 2017 Sep 8. |
| 32830233 | Background | Kirstein B, Neudeck S, Gaspar T, Piorkowski J, Wechselberger S, Kronborg MB, Zedda A, Hankel A, El-Armouche A, Tomala J, Schmidt T, Mayer J, Wagner M, Ulbrich S, Pu L, Richter U, Huo Y, Piorkowski C. Left atrial fibrosis predicts left ventricular ejection fraction response after atrial fibrillation ablation in heart failure patients: the Fibrosis-HF Study. Europace. 2020 Dec 23;22(12):1812-1821. doi: 10.1093/europace/euaa179. |
| 36565183 | Background | Bergonti M, Spera FR, Ferrero TG, Nsahlai M, Bonomi A, Tijskens M, Boris W, Saenen J, Huybrechts W, Miljoen H, Gonzalez-Juanatey JR, Martinez-Sande JL, Vandaele L, Wittock A, Heidbuchel H, Valderrabano M, Rodriguez-Manero M, Sarkozy A. Characterization of Atrial Substrate to Predict the Success of Pulmonary Vein Isolation: The Prospective, Multicenter MASH-AF II (Multipolar Atrial Substrate High Density Mapping in Atrial Fibrillation) Study. J Am Heart Assoc. 2023 Jan 3;12(1):e027795. doi: 10.1161/JAHA.122.027795. Epub 2022 Dec 24. |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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