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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by IRCCS San Raffaele
Sponsor:
Information provided by (Responsible Party):
Paolo Della Bella, IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT01547208
First received: February 28, 2012
Last updated: May 22, 2014
Last verified: May 2014

February 28, 2012
May 22, 2014
September 2012
September 2018   (final data collection date for primary outcome measure)
  • Occurrence of the first appropriate ICD shock during phase A [ Time Frame: Event Driven ] [ Designated as safety issue: No ]
  • Number of patients showing worsening heart failure hospitalizations or deaths from any cause during phase B [ Time Frame: Two Years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01547208 on ClinicalTrials.gov Archive Site
  • Number of patients showing cardiac deaths during phase B [ Time Frame: Two Years ] [ Designated as safety issue: No ]
  • Number of patients showing electrical storm (ES) recurrences during phase B [ Time Frame: Two Years ] [ Designated as safety issue: No ]
  • Number of patients showing VT recurrences during phase B [ Time Frame: Two Years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Does Timing of VT Ablation Affect Prognosis in Patients With an Implantable Cardioverter-defibrillator?
Not Provided

The purpose of this study is to assess whether if 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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Ventricular Tachycardias
  • 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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
590
September 2018
September 2018   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Pasquale Vergara pasqualevergara@yahoo.it
Contact: Paolo Della Bella dellabella.paolo@hsr.it
Czech Republic,   France,   Germany,   Italy,   Switzerland
 
NCT01547208
PARTITA
No
Paolo Della Bella, IRCCS San Raffaele
IRCCS San Raffaele
Not Provided
Study Director: Paolo Della Bella IRCCS San Raffaele
Study Director: Pasquale Vergara IRCCS San Raffaele
IRCCS San Raffaele
May 2014

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