"Ventricular Tachycardia Ablation Registry".

Ventricular Tachycardia Clinical Trial

Official title:

"Ventricular Tachycardia Ablation Registry". Italian Registry of Substrate Mapping and VT Ablation With the Precision Mapping System and Flexability Catheter.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03649022
• Other study ID #: OSR-ARITM-001
• Status: Active, not recruiting
• Start date: July 25, 2017
• Est. completion date: January 31, 2021

Study information

• Verified date: April 2020
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 312
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Device:
• 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)

Locations

Country	Name	City	State
Italy	IRCCS San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Paolo Della Bella

Country where clinical trial is conducted

Italy, 

References & Publications (8)

Aliot EM, Stevenson WG, Almendral-Garrote JM, Bogun F, Calkins CH, Delacretaz E, Bella PD, Hindricks G, Jaïs 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. — View Citation

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. — View Citation

Kuck KH, Schaumann A, Eckardt L, Willems S, Ventura R, Delacrétaz 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. — View Citation

Priori SG, Blomström-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, Norekvål 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late potential abolition and ventricular tachycardia noninducibility	Combined procedural endpoint of late potential (LP) abolition and VT noninducibility (endpoint expected in 50% of cases).; LP abolition assessed as % of persistent LP area at remap after ablation, compared to the basal activation map.	Intraprocedural
Primary	Ventricular tachycardia recurrence	Freedom from Ventricular Tachycardia episodes requiring ICD Intervention (shock or Anti-Tachycardia Pacing)	12 months
Secondary	Complications	Periprocedural complications	During hospitalization: starting during the procedure until discharge
Secondary	Complications	Long term catheter ablation complications	12 months
Secondary	Procedural parameters	Procedure duration measured in minutes	Intraprocedural
Secondary	Procedural parameters	Fluoroscopy exposure measured in Gycm2	Intraprocedural
Secondary	Assessment of cardiac mapping system EnSite Precision™ software (St.Jude, now Abbott)	Geometry precision, descriptive	Intraprocedural
Secondary	Assessment of cardiac mapping system EnSite Precision™ software (St.Jude, now Abbott)	Mapping accuracy, descriptive	Intraprocedural
Secondary	Assessment of cardiac mapping system EnSite Precision™ software (St.Jude, now Abbott)	System overall stability, descriptive	Intraprocedural
Secondary	Assessment of cardiac mapping system EnSite Precision™ software (St.Jude, now Abbott)	Non-recoverable shifts/drifts, descriptive	Intraprocedural