"Ventricular Tachycardia Ablation Registry".

NCT ID: NCT03649022

Last Updated: 2020-04-14

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

312 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-25

Study Completion Date

2021-01-31

Brief Summary

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Catheter ablation of Ventricular Tachycardias is a well-established approach in clinical practice in patients with Implantable Cardioverter Defibrillator (ICD) implanted. Previous studies have shown a significant reduction in appropriate shocks (\~ 20%) and a significant reduction in hospitalizations for cardiovascular reasons (\~ 12%) in patients with ischemic heart disease treated with ablation. Recent works have also shown the effectiveness of the ablation procedure using as procedural target the reduction of late potentials. However, actually it is necessary to have an homogenize and accepted mapping scheme in Sinus Rhythm to ablate Ventricular Tachycardias related to scar substrate in patients with:

* 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.

Detailed Description

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This is an Italian multicenter, observational, prospective and retrospective registry.

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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Ventricular Tachycardia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with an implanted ICD
* 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

* Contraindication to anticoagulants
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Paolo Della Bella

OTHER

Sponsor Role lead

Responsible Party

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Paolo Della Bella

MD

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status

Countries

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Italy

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.

Reference Type BACKGROUND
PMID: 18160685 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26320108 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24833642 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22294707 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20644021 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19443434 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20109864 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24891043 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36752462 (View on PubMed)

Other Identifiers

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OSR-ARITM-001

Identifier Type: -

Identifier Source: org_study_id

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