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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01547208
Recruitment Status : Recruiting
First Posted : March 7, 2012
Last Update Posted : October 2, 2017
Information provided by (Responsible Party):
Paolo Della Bella, IRCCS San Raffaele

Brief 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.

Condition or disease Intervention/treatment Phase
Ventricular Tachycardias Procedure: Immediate radiofrequency ablation of ventricular tachycardia Procedure: Radiofrequency ablation of ventricular tachycardia Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 590 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2012
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

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

Primary Outcome Measures :
  1. Occurrence of the first appropriate ICD shock during phase A [ Time Frame: Event Driven ]
  2. Number of patients showing worsening heart failure hospitalizations or deaths from any cause during phase B [ Time Frame: Two Years ]

Secondary Outcome Measures :
  1. Number of patients showing cardiac deaths during phase B [ Time Frame: Two Years ]
  2. Number of patients showing electrical storm (ES) recurrences during phase B [ Time Frame: Two Years ]
  3. Number of patients showing VT recurrences during phase B [ Time Frame: Two Years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01547208

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Contact: Andrea Radinovic
Contact: Paolo Della Bella

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


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Responsible Party: Paolo Della Bella, Director of Arrhythmia Department and Clinical Electrophysiology Laboratories, IRCCS San Raffaele Identifier: NCT01547208     History of Changes
Other Study ID Numbers: PARTITA
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017
Keywords provided by Paolo Della Bella, IRCCS San Raffaele:
ICD shocks
Ventricular tachycardias ablation
Timing of ablation
Electrical storm
Arrhythmic storm
Additional relevant MeSH terms:
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Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes