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Ventricular TachycardiaNCT03649022

"Ventricular Tachycardia Ablation Registry".

An observational study of Ventricular Tachycardia, run by Paolo Della Bella at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ventricular Tachycardia
What is being tested?
Catheter ablation
Type of treatment
Medical device
How many people
312 participants
Where
1 siteItaly
Study dates
25 Jul 2017to 31 Jan 2021
How long will I take part?
1 Year
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Population of patients with defibrillator, indicated to perform catheter ablation of ventricular tachycardia related to substrate scar due to previous MI, previous myocarditis and arrhythmogenic right ventricular dysplasia, idiopathic dilated cardiomyopathy guided by electroanatomic mapping system.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • IRCCS San Raffaele

    Milan, 20132

Other trials in Italy

About this study

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

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)
Read more

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.

Read the detailed 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.

Being tested
Catheter ablation
Medical subject headings
Tachycardia, Ventricular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Catheter ablationDevice

    Ventricular Tachycardia ablation, that will be performed per clinical practice, by using EnSite Precision mapping system with the Flexability catheter (St.Jude, now Abbott)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Intraprocedural

  2. Ventricular tachycardia recurrence

    Freedom from Ventricular Tachycardia episodes requiring ICD Intervention (shock or Anti-Tachycardia Pacing)

    Measured: 12 months

Secondary outcomes (8)

  1. Complications

    Periprocedural complications

    Measured: During hospitalization: starting during the procedure until discharge

  2. Complications

    Long term catheter ablation complications

    Measured: 12 months

  3. Procedural parameters

    Procedure duration measured in minutes

    Measured: Intraprocedural

  4. Procedural parameters

    Fluoroscopy exposure measured in Gycm2

    Measured: Intraprocedural

  5. Assessment of cardiac mapping system EnSite Precision™ software (St.Jude, now Abbott)

    Geometry precision, descriptive

    Measured: Intraprocedural

  6. Assessment of cardiac mapping system EnSite Precision™ software (St.Jude, now Abbott)

    Mapping accuracy, descriptive

    Measured: Intraprocedural

  7. Assessment of cardiac mapping system EnSite Precision™ software (St.Jude, now Abbott)

    System overall stability, descriptive

    Measured: Intraprocedural

  8. Assessment of cardiac mapping system EnSite Precision™ software (St.Jude, now Abbott)

    Non-recoverable shifts/drifts, descriptive

    Measured: Intraprocedural

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2018
  2. Study start25 Jul 2017
  3. Primary completion31 Jan 2021 (estimated)
  4. Study completion31 Jan 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
312 participants (actual)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT03649022
Sponsor's protocol ID
OSR-ARITM-001
Status last verified
Apr 2020
First submitted
8 Aug 2018
Last updated
14 Apr 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 18160685

  • 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.

    PubMed 26320108

  • 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.

    PubMed 24833642

  • 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.

    PubMed 22294707

  • 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.

    PubMed 20644021

  • 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.

    PubMed 19443434

  • 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.

    PubMed 20109864

  • 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.

    PubMed 24891043

  • 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.

    PubMed 36752462

Questions about this trial

What is this clinical trial studying?

An observational study of Ventricular Tachycardia, run by Paolo Della Bella at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Late potential abolition and ventricular tachycardia noninducibility (time frame: Intraprocedural). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03649022, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.

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