Does Timing of VT Ablation Affect Prognosis in Patients With an Implantable Cardioverter-defibrillator?

Last updated: April 12, 2020
Sponsor: IRCCS San Raffaele
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Defect

Heart Disease

Cardiac Disease

Treatment

N/A

Clinical Study ID

NCT01547208
PARTITA
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to assess whether the burden of untreated non-sustained ventricular tachycardias (VTs), or episodes treated with anti-tachycardia pacing, correlates with appropriate implantable cardiac defibrillator (ICD) shock therapies and to evaluate if the timing of radiofrequency VT ablation affects the prognosis of ICD recipients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients already implanted with ICD (single-/dual -chamber, with or without cardiacresynchronization therapy) for primary or secondary prevention of sudden cardiac death

Exclusion

Exclusion Criteria: Phase A exclusion Criteria:

  • General contraindication to transcatheter ablation

  • Contraindication to antithrombotic therapy

  • Patients chronically treated with class I and III antiarrhythmic drugs Phase B exclusion criteria:

  • Patients developing first occurrence of incessant VTs

  • Patients receiving a shock for first occurrence of clinically verified ventricularfibrillation

  • Patients with aetiology differing from ischemic heart disease for coronary arterydisease and from non-ischemic dilatative cardiomyopathy

Study Design

Total Participants: 590
Study Start date:
September 01, 2012
Estimated Completion Date:
September 30, 2022

Study Description

Enrolled patients will remain in a first phase of the study until the first appropriate ICD shock will be delivered.

The objective of this first stage is to assess whether the burden of untreated non sustained VTs or episodes treated with anti-tachycardia pacing is predictive of appropriate ICD shocks.

The second phase of the study will start after the first appropriate ICD shock delivered for VT.

Patients will be then randomized to immediate VT ablation or to standard treatment, meaning waiting until next arrhythmic storm to perform a VT ablation procedure.

The objective of this phase is compare the rate of worsening heart failure hospitalizations and deaths from any cause between the two groups.

Connect with a study center

  • Brussels Heart Center

    Bruxelles,
    Belgium

    Site Not Available

  • IKEM Hospital

    Prague,
    Czechia

    Site Not Available

  • Hôpital cardiologique du Haut-Lévêque

    Bordeaux,
    France

    Active - Recruiting

  • Herz und Gefass Klinik

    Bad Neustadt,
    Germany

    Site Not Available

  • Herz und Gefass Klinik

    Bad Neustadt An Der Saale,
    Germany

    Active - Recruiting

  • Ospedale Oglio Po

    Casalmaggiore, Cremona
    Italy

    Site Not Available

  • Ospedale di Desio

    Desio, Milan
    Italy

    Active - Recruiting

  • Ospedale di Montebelluna

    Montebelluna, Treviso
    Italy

    Active - Recruiting

  • Ospedale Mater Domini

    Castellanza, Varese
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Sant'Antonio Abate

    Gallarate, Varese
    Italy

    Active - Recruiting

  • Ospedale di Mirano

    Mirano, Venice
    Italy

    Site Not Available

  • Ospedale S. Donato

    Arezzo,
    Italy

    Active - Recruiting

  • Ospedale Cardinal Massaia

    Asti,
    Italy

    Site Not Available

  • AO Policlinico di Bari

    Bari,
    Italy

    Site Not Available

  • Ospedale Brotzu

    Cagliari,
    Italy

    Active - Recruiting

  • Osp. Fondazione Giovanni Paolo II

    Campobasso,
    Italy

    Active - Recruiting

  • AO Pugliese Ciaccio

    Catanzaro,
    Italy

    Active - Recruiting

  • Azienda Sanitaria Spezzino

    La Spezia,
    Italy

    Site Not Available

  • Ospedale Manzoni

    Lecco,
    Italy

    Site Not Available

  • IRCCS San Raffaele

    Milan,
    Italy

    Active - Recruiting

  • Fondazione G. Monasterio

    Pisa,
    Italy

    Active - Recruiting

  • Policlinico Casilino

    Rome,
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Valtellina e Valchiavenna

    Sondrio,
    Italy

    Active - Recruiting

  • Ospedale Santa Maria

    Terni,
    Italy

    Site Not Available

  • Ospedale Civile Maggiore

    Verona,
    Italy

    Active - Recruiting

  • Centro Hospitalar Lisboa Norte, Hospital Universitário de Santa Maria

    Lisbon,
    Portugal

    Active - Recruiting

  • Lausanne Hospital

    Lausanne,
    Switzerland

    Active - Recruiting

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