Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
312 participants
OBSERVATIONAL
2017-07-25
2021-01-31
Brief Summary
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* Previous MI
* Previous myocarditis
* Arrhythmogenic Right Ventricular Dysplasia (ARVD)
* Idiopathic Dilated Cardiomyopathy (IDCM)
Scope of the registry is to collect data during cardiac mapping in Sinus Rhythm in patients indicated for Ventricular Tachycardia ablation, that will be performed per clinical practice, by using the St. Jude Medical EnSiteTM PrecisionTM mapping system.
The objective of the present registry is: to assess the acute and long-term efficacy of the strategy of substrate abolition (abolishment of complex and late potentials) guided by electroanatomic mapping with Precision software.
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Detailed Description
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Data will be collected during enrollment/baseline, procedure, pre-discharge and during the follow-up visits according to the standard practice of participating centers, with mandatory visits at 6 and 12 months. Data can also be collected retrospectively, prior informed consent of the patient.
The planned enrollment duration is approximately 24 months.
Conditions
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Study Design
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COHORT
OTHER
Interventions
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Catheter ablation
Ventricular Tachycardia ablation, that will be performed per clinical practice, by using EnSite Precision mapping system with the Flexability catheter (St.Jude, now Abbott)
Eligibility Criteria
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Inclusion Criteria
* Patients with indication to Ventricular Tachycardia Ablation procedure, supported by EnSite Precision 3D mapping system (previous MI, myocarditis, ARVD, IDCM)
* Age 18 years or more
* Able to provide an informed consent to participate to the registry and available to respect the assessments described in the protocol
Exclusion Criteria
* Presence of thrombi
* Presence of Mitral and Aortic prosthetic valve
* Recent (\<3 months) myocardial infarction or unstable angina or Coronary Artery Bypass
* Pregnant or nursing
* Ventricular Tachycardia caused by reversible pathology
* \< 1 Year life expectancy according to the investigator
* Contraindication to the use of ablation/diagnostic catheters or to cardiac catheterism
18 Years
ALL
No
Sponsors
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Paolo Della Bella
OTHER
Responsible Party
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Paolo Della Bella
MD
Principal Investigators
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Paolo Della Bella, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS S Raffaele
Locations
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IRCCS San Raffaele
Milan, , Italy
Countries
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References
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Reddy VY, Reynolds MR, Neuzil P, Richardson AW, Taborsky M, Jongnarangsin K, Kralovec S, Sediva L, Ruskin JN, Josephson ME. Prophylactic catheter ablation for the prevention of defibrillator therapy. N Engl J Med. 2007 Dec 27;357(26):2657-65. doi: 10.1056/NEJMoa065457.
Priori SG, Blomstrom-Lundqvist C, Mazzanti A, Blom N, Borggrefe M, Camm J, Elliott PM, Fitzsimons D, Hatala R, Hindricks G, Kirchhof P, Kjeldsen K, Kuck KH, Hernandez-Madrid A, Nikolaou N, Norekval TM, Spaulding C, Van Veldhuisen DJ; ESC Scientific Document Group. 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: The Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC). Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC). Eur Heart J. 2015 Nov 1;36(41):2793-2867. doi: 10.1093/eurheartj/ehv316. Epub 2015 Aug 29. No abstract available.
Silberbauer J, Oloriz T, Maccabelli G, Tsiachris D, Baratto F, Vergara P, Mizuno H, Bisceglia C, Marzi A, Sora N, Guarracini F, Radinovic A, Cireddu M, Sala S, Gulletta S, Paglino G, Mazzone P, Trevisi N, Della Bella P. Noninducibility and late potential abolition: a novel combined prognostic procedural end point for catheter ablation of postinfarction ventricular tachycardia. Circ Arrhythm Electrophysiol. 2014 Jun;7(3):424-35. doi: 10.1161/CIRCEP.113.001239. Epub 2014 May 15.
Deo R, Albert CM. Epidemiology and genetics of sudden cardiac death. Circulation. 2012 Jan 31;125(4):620-37. doi: 10.1161/CIRCULATIONAHA.111.023838. No abstract available.
Tung R, Boyle NG, Shivkumar K. Catheter ablation of ventricular tachycardia. Circulation. 2010 Jul 20;122(3):e389-91. doi: 10.1161/CIRCULATIONAHA.110.963371. No abstract available.
Aliot EM, Stevenson WG, Almendral-Garrote JM, Bogun F, Calkins CH, Delacretaz E, Bella PD, Hindricks G, Jais P, Josephson ME, Kautzner J, Kay GN, Kuck KH, Lerman BB, Marchlinski F, Reddy V, Schalij MJ, Schilling R, Soejima K, Wilber D; European Heart Rhythm Association; European Society of Cardiology; Heart Rhythm Society. EHRA/HRS Expert Consensus on Catheter Ablation of Ventricular Arrhythmias: developed in a partnership with the European Heart Rhythm Association (EHRA), a Registered Branch of the European Society of Cardiology (ESC), and the Heart Rhythm Society (HRS); in collaboration with the American College of Cardiology (ACC) and the American Heart Association (AHA). Europace. 2009 Jun;11(6):771-817. doi: 10.1093/europace/eup098. Epub 2009 May 14. No abstract available.
Kuck KH, Schaumann A, Eckardt L, Willems S, Ventura R, Delacretaz E, Pitschner HF, Kautzner J, Schumacher B, Hansen PS; VTACH study group. Catheter ablation of stable ventricular tachycardia before defibrillator implantation in patients with coronary heart disease (VTACH): a multicentre randomised controlled trial. Lancet. 2010 Jan 2;375(9708):31-40. doi: 10.1016/S0140-6736(09)61755-4.
Themistoclakis S, Raviele A, China P, Pappone C, De Ponti R, Revishvili A, Aliot E, Kuck KH, Hoff PI, Shah D, Almendral J, Manolis AS, Chierchia GB, Oto A, Vatasescu RG, Sinkovec M, Cappato R; Atrial Fibrillation Survey Investigators. Prospective European survey on atrial fibrillation ablation: clinical characteristics of patients and ablation strategies used in different countries. J Cardiovasc Electrophysiol. 2014 Oct;25(10):1074-81. doi: 10.1111/jce.12462. Epub 2014 Jul 8.
Radinovic A, Peretto G, Sgarito G, Cauti FM, Castro A, Narducci ML, Mantovan R, Scaglione M, Solimene F, Scopinaro A, Tondo C, Filippini G, Bianco E, Bonso A, Calzolari V, Ferraris F, Zardini M, Piacenti M, D'Angelo G, Bosica F, Della Bella P. Matching Ablation Endpoints to Long-Term Outcome: The Prospective Multicenter Italian Ventricular Tachycardia Ablation Registry. JACC Clin Electrophysiol. 2023 Jun;9(6):836-847. doi: 10.1016/j.jacep.2022.10.038. Epub 2023 Jan 18.
Other Identifiers
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OSR-ARITM-001
Identifier Type: -
Identifier Source: org_study_id
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