Does Timing of VT Ablation Affect Prognosis in Patients With an Implantable Cardioverter-defibrillator? (PARTITA)
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| ClinicalTrials.gov Identifier: NCT01547208 |
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Recruitment Status :
Recruiting
First Posted : March 7, 2012
Last Update Posted : October 2, 2017
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Sponsor:
IRCCS San Raffaele
Information provided by (Responsible Party):
Paolo Della Bella, IRCCS San Raffaele
- Study Details
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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 |
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 2020 |
| Estimated Study Completion Date : | September 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Group A
Patients will be randomized to a VT ablation procedure immediately after an appropriate ICD shock
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Procedure: Immediate radiofrequency ablation of ventricular tachycardia
Radiofrequency ablation of ventricular tachycardia is performed immediately after an appropriate ICD shock |
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Active Comparator: Group B
Patients will wait until an arrhythmic storm to undergo a VT ablation procedure
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Procedure: Radiofrequency ablation of ventricular tachycardia
Radiofrequency ablation of ventricular tachycardia will be performed after an arrhythmic storm occurs |
Primary Outcome Measures :
- 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 ]
Secondary Outcome Measures :
- 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 |
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
| Contact: Andrea Radinovic | radinovic.andrea@hsr.it | ||
| Contact: Paolo Della Bella | dellabella.paolo@hsr.it |
Locations
| Belgium | |
| Brussels Heart Center | Not yet recruiting |
| Bruxelles, Belgium | |
| Contact: Gaetano Paparella | |
| Principal Investigator: Gaetano Paparella | |
| Czechia | |
| IKEM Hospital | Not yet recruiting |
| Prague, Czechia | |
| Contact: Josef Kautzner | |
| Principal Investigator: Josef Kautzner | |
| France | |
| Hôpital cardiologique du Haut-Lévêque | Recruiting |
| Bordeaux, France | |
| Contact: Pierre Jais | |
| Principal Investigator: Pierre Jais | |
| Germany | |
| Herz und Gefass Klinik | Recruiting |
| Bad Neustadt, Germany | |
| Contact: Thomas Deneke | |
| Principal Investigator: Thomas Deneke | |
| Italy | |
| Ospedale di Desio | Recruiting |
| Desio, Milan, Italy | |
| Contact: Giuseppe Mantovani | |
| Principal Investigator: Giuseppe Mantovani | |
| Ospedale di Montebelluna | Recruiting |
| Montebelluna, Treviso, Italy | |
| Contact: Diego Vaccari | |
| Principal Investigator: Diego Vaccari | |
| Ospedale Mater Domini | Recruiting |
| Castellanza, Varese, Italy | |
| Contact: Massimo Tritto | |
| Principal Investigator: Massimo Tritto | |
| Azienda Ospedaliera Sant'Antonio Abate | Recruiting |
| Gallarate, Varese, Italy | |
| Contact: Daniela Orsida | |
| Principal Investigator: Daniela Orsida | |
| Principal Investigator: Ivan Caico | |
| Ospedale di Mirano | Not yet recruiting |
| Mirano, Venice, Italy | |
| Contact: Franco Zoppo | |
| Principal Investigator: Franco Zoppo | |
| Ospedale S. Donato | Recruiting |
| Arezzo, Italy | |
| Contact: Pasquale Notarstefano | |
| Principal Investigator: Pasquale Notarstefano | |
| AO Policlinico di Bari | Not yet recruiting |
| Bari, Italy | |
| Contact: Giuseppe Grandinetti | |
| Principal Investigator: Giuseppe Grandinetti | |
| Ospedale Brotzu | Recruiting |
| Cagliari, Italy | |
| Contact: Gianfranco Tola | |
| Principal Investigator: Gianfranco Tola | |
| Osp. Fondazione Giovanni Paolo II | Recruiting |
| Campobasso, Italy | |
| Contact: Matteo Santamaria | |
| Principal Investigator: Matteo Santamaria | |
| AO Pugliese Ciaccio | Recruiting |
| Catanzaro, Italy | |
| Contact: Giampiero Maglia | |
| Principal Investigator: Giampiero Maglia | |
| IRCCS San Raffaele | Recruiting |
| Milan, Italy | |
| Contact: Andrea Radinovic radinovic.andrea@hsr.it | |
| Principal Investigator: Paolo Della bella | |
| Principal Investigator: Andrea Radinovic | |
| Fondazione G. Monasterio | Recruiting |
| Pisa, Italy | |
| Contact: Marcello Piacenti | |
| Principal Investigator: Marcello Piacenti | |
| Policlinico Casilino | Recruiting |
| Rome, Italy | |
| Contact: Alessio Borrelli | |
| Principal Investigator: Leonardo Calò | |
| Principal Investigator: Alessio Borrelli | |
| Azienda Ospedaliera Valtellina e Valchiavenna | Recruiting |
| Sondrio, Italy | |
| Contact: Maurizio Moizi | |
| Principal Investigator: Maurizio Moizi | |
| Ospedale Civile Maggiore | Recruiting |
| Verona, Italy | |
| Contact: Giovanni Morani | |
| Principal Investigator: Giovanni Morani | |
| Portugal | |
| Centro Hospitalar Lisboa Norte, Hospital Universitário de Santa Maria | Recruiting |
| Lisbon, Portugal | |
| Contact: Luis Carpinteiro | |
| Principal Investigator: Luis Carpinteiro | |
| Switzerland | |
| Lausanne Hospital | Recruiting |
| Lausanne, Switzerland | |
| Contact: Etienne P Pruvot | |
| Principal Investigator: Etienne Pruvot | |
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
| Study Director: | Paolo Della Bella | IRCCS San Raffaele | |
| Study Director: | Andrea Radinovic | IRCCS San Raffaele |
Publications:
| Responsible Party: | Paolo Della Bella, Director of Arrhythmia Department and Clinical Electrophysiology Laboratories, IRCCS San Raffaele |
| ClinicalTrials.gov Identifier: | NCT01547208 History of Changes |
| Other Study ID Numbers: |
PARTITA |
| First Posted: | March 7, 2012 Key Record Dates |
| Last Update Posted: | October 2, 2017 |
| Last Verified: | September 2017 |
Keywords provided by Paolo Della Bella, IRCCS San Raffaele:
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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 Pathologic Processes |