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

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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

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

Study Director: | Paolo Della Bella | IRCCS San Raffaele | |
Study Director: | Andrea Radinovic | IRCCS San Raffaele |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
ICD shocks Ventricular tachycardias ablation Timing of ablation Electrical storm Arrhythmic storm |
Tachycardia Tachycardia, Ventricular Arrhythmias, Cardiac Heart Diseases |
Cardiovascular Diseases Cardiac Conduction System Disease Pathologic Processes |