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

April 12, 2020 updated by: Paolo Della Bella, IRCCS San Raffaele
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

590

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium
        • Not yet recruiting
        • Brussels Heart Center
        • Contact:
          • Gaetano Paparella
        • Principal Investigator:
          • Gaetano Paparella
  • Czechia
      • Prague, Czechia
        • Not yet recruiting
        • IKEM Hospital
        • Contact:
          • Josef Kautzner
        • Principal Investigator:
          • Josef Kautzner
  • France
      • Bordeaux, France
        • Recruiting
        • Hôpital Cardiologique Du Haut-Lévêque
        • Contact:
          • Pierre JAÏS
        • Principal Investigator:
          • Pierre Jais
  • Germany
      • Bad Neustadt An Der Saale, Germany
        • Recruiting
        • Herz und Gefass Klinik
        • Contact:
          • Thomas Deneke
        • Principal Investigator:
          • Thomas Deneke
  • Italy
      • Arezzo, Italy
        • Recruiting
        • Ospedale S. Donato
        • Contact:
          • Pasquale Notarstefano
        • Principal Investigator:
          • Pasquale Notarstefano
      • Bari, Italy
        • Not yet recruiting
        • AO Policlinico di Bari
        • Contact:
          • Giuseppe Grandinetti
        • Principal Investigator:
          • Giuseppe Grandinetti
      • Cagliari, Italy
        • Recruiting
        • Ospedale Brotzu
        • Contact:
          • Gianfranco Tola
        • Principal Investigator:
          • Gianfranco Tola
      • Campobasso, Italy
        • Recruiting
        • Osp. Fondazione Giovanni Paolo II
        • Contact:
          • Matteo Santamaria
      • Catanzaro, Italy
        • Recruiting
        • AO Pugliese Ciaccio
        • Contact:
          • Giampiero Maglia
        • Principal Investigator:
          • Giampiero Maglia
      • Milan, Italy
        • Recruiting
        • IRCCS San Raffaele
        • Contact:
        • Principal Investigator:
          • Paolo Della bella
        • Principal Investigator:
          • Andrea Radinovic
      • Pisa, Italy
        • Recruiting
        • Fondazione G. Monasterio
        • Contact:
          • Marcello Piacenti
        • Principal Investigator:
          • Marcello Piacenti
      • Rome, Italy
        • Recruiting
        • Policlinico Casilino
        • Contact:
          • Alessio Borrelli
        • Principal Investigator:
          • Alessio Borrelli
      • Sondrio, Italy
        • Recruiting
        • Azienda Ospedaliera Valtellina e Valchiavenna
        • Contact:
          • Maurizio Moizi
        • Principal Investigator:
          • Maurizio Moizi
      • Verona, Italy
        • Recruiting
        • Ospedale Civile Maggiore
        • Contact:
          • Giovanni Morani
        • Principal Investigator:
          • Giovanni Morani
    • Milan
      • Desio, Milan, Italy
        • Recruiting
        • Ospedale di Desio
        • Contact:
          • Giuseppe Mantovani
        • Principal Investigator:
          • Giuseppe Mantovani
    • Treviso
      • Montebelluna, Treviso, Italy
        • Recruiting
        • Ospedale di Montebelluna
        • Contact:
          • Diego Vaccari
        • Principal Investigator:
          • Diego Vaccari
    • Varese
      • Castellanza, Varese, Italy
        • Recruiting
        • Ospedale Mater Domini
        • Contact:
          • Massimo Tritto
        • Principal Investigator:
          • Massimo Tritto
      • Gallarate, Varese, Italy
        • Recruiting
        • Azienda Ospedaliera Sant'Antonio Abate
        • Contact:
          • Daniela Orsida
        • Principal Investigator:
          • Daniela Orsida
        • Principal Investigator:
          • Ivan Caico
    • Venice
      • Mirano, Venice, Italy
        • Not yet recruiting
        • Ospedale di Mirano
        • Contact:
          • Franco Zoppo
        • Principal Investigator:
          • Franco Zoppo
  • Portugal
      • Lisbon, Portugal
        • Recruiting
        • Centro Hospitalar Lisboa Norte, Hospital Universitário de Santa Maria
        • Contact:
          • Luis Carpinteiro
        • Principal Investigator:
          • Luis Carpinteiro
  • Switzerland
      • Lausanne, Switzerland
        • Recruiting
        • Lausanne Hospital
        • Contact:
          • Etienne P Pruvot
        • Principal Investigator:
          • Etienne Pruvot

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Patients will be randomized to a VT ablation procedure immediately after an appropriate ICD shock
Procedure: Immediate radiofrequency ablation of ventricular tachycardia
Radiofrequency ablation of ventricular tachycardia is performed immediately after an appropriate ICD shock
Active Comparator: Group B
Patients will wait until an arrhythmic storm to undergo a VT ablation procedure
Procedure: Radiofrequency ablation of ventricular tachycardia
Radiofrequency ablation of ventricular tachycardia will be performed after an arrhythmic storm occurs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of the first appropriate ICD shock during phase A
Time Frame: Event Driven
Event Driven
Number of patients showing worsening heart failure hospitalizations or deaths from any cause during phase B
Time Frame: Two Years
Two Years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients showing cardiac deaths during phase B
Time Frame: Two Years
Two Years
Number of patients showing electrical storm (ES) recurrences during phase B
Time Frame: Two Years
Two Years
Number of patients showing VT recurrences during phase B
Time Frame: Two Years
Two Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Investigators

  • Study Director: Paolo Della Bella, IRCCS San Raffaele
  • Study Director: Andrea Radinovic, IRCCS San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

February 28, 2012

First Submitted That Met QC Criteria

March 3, 2012

First Posted (Estimate)

March 7, 2012

Study Record Updates

Last Update Posted (Actual)

April 14, 2020

Last Update Submitted That Met QC Criteria

April 12, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PARTITA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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