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
|Condition or disease||Intervention/treatment||Phase|
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||September 2022|
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 ]
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 Radinovicemail@example.com|
|Contact: Paolo Della Bellafirstname.lastname@example.org|
|Study Director:||Paolo Della Bella||IRCCS San Raffaele|
|Study Director:||Andrea Radinovic||IRCCS San Raffaele|