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

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ClinicalTrials.gov Identifier: NCT01547208
Recruitment Status : Unknown
Verified April 2020 by Paolo Della Bella, IRCCS San Raffaele.
Recruitment status was:  Recruiting
First Posted : March 7, 2012
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
Paolo Della Bella, IRCCS San Raffaele

Tracking Information
First Submitted Date  ICMJE February 28, 2012
First Posted Date  ICMJE March 7, 2012
Last Update Posted Date April 14, 2020
Study Start Date  ICMJE September 2012
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2012)
  • Occurrence of the first appropriate ICD shock during phase A [ Time Frame: Event Driven ]
  • Number of patients showing worsening heart failure hospitalizations or deaths from any cause during phase B [ Time Frame: Two Years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2012)
  • Number of patients showing cardiac deaths during phase B [ Time Frame: Two Years ]
  • Number of patients showing electrical storm (ES) recurrences during phase B [ Time Frame: Two Years ]
  • Number of patients showing VT recurrences during phase B [ Time Frame: Two Years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does Timing of VT Ablation Affect Prognosis in Patients With an Implantable Cardioverter-defibrillator?
Official Title  ICMJE Not Provided
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ventricular Tachycardias
Intervention  ICMJE
  • Procedure: Immediate radiofrequency ablation of ventricular tachycardia
    Radiofrequency ablation of ventricular tachycardia is performed immediately after an appropriate ICD shock
  • Procedure: Radiofrequency ablation of ventricular tachycardia
    Radiofrequency ablation of ventricular tachycardia will be performed after an arrhythmic storm occurs
Study Arms  ICMJE
  • Experimental: Group A
    Patients will be randomized to a VT ablation procedure immediately after an appropriate ICD shock
    Intervention: Procedure: Immediate radiofrequency ablation of ventricular tachycardia
  • Active Comparator: Group B
    Patients will wait until an arrhythmic storm to undergo a VT ablation procedure
    Intervention: Procedure: Radiofrequency ablation of ventricular tachycardia
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 3, 2012)
590
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Czechia,   France,   Germany,   Italy,   Portugal,   Switzerland
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01547208
Other Study ID Numbers  ICMJE PARTITA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Paolo Della Bella, IRCCS San Raffaele
Original Responsible Party Same as current
Current Study Sponsor  ICMJE IRCCS San Raffaele
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Paolo Della Bella IRCCS San Raffaele
Study Director: Andrea Radinovic IRCCS San Raffaele
PRS Account IRCCS San Raffaele
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP