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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 : Recruiting
First Posted : March 7, 2012
Last Update Posted : April 14, 2020
Sponsor:
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 2022
Estimated Study Completion Date : September 2022

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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT01547208


Contacts
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Contact: Andrea Radinovic radinovic.andrea@hsr.it
Contact: Paolo Della Bella dellabella.paolo@hsr.it

Locations
Show Show 21 study locations
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
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Study Director: Paolo Della Bella IRCCS San Raffaele
Study Director: Andrea Radinovic IRCCS San Raffaele
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Paolo Della Bella, Director of Arrhythmia Department and Clinical Electrophysiology Laboratories, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT01547208    
Other Study ID Numbers: PARTITA
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
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
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes