Clinical trial NCT01547208: Does Timing of VT Ablation Affect Prognosis in Patients With an Implantable Cardioverter-defibrillator?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ventricular Tachycardias
Keywords: ICD shocks
Ventricular tachycardias ablation
Timing of ablation
Electrical storm
Arrhythmic storm
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2012-03-07
Enrollment: 590
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Occurrence of the first appropriate ICD shock during phase A
timeFrame: Event Driven
measure: Number of patients showing worsening heart failure hospitalizations or deaths from any cause during phase B
timeFrame: Two Years
Secondary outcomes:
measure: Number of patients showing cardiac deaths during phase B
timeFrame: Two Years
measure: Number of patients showing electrical storm (ES) recurrences during phase B
timeFrame: Two Years
measure: Number of patients showing VT recurrences during phase B
timeFrame: Two Years
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Brussels Heart Center
city: Prague
country: Czechia
facility: IKEM Hospital
city: Bordeaux
country: France
facility: Hôpital cardiologique du Haut-Lévêque
city: Bad Neustadt An Der Saale
country: Germany
facility: Herz und Gefass Klinik
city: Desio
country: Italy
facility: Ospedale di Desio
state: Milan
city: Montebelluna
country: Italy
facility: Ospedale di Montebelluna
state: Treviso
city: Castellanza
country: Italy
facility: Ospedale Mater Domini
state: Varese
city: Gallarate
country: Italy
facility: Azienda Ospedaliera Sant'Antonio Abate
state: Varese
city: Mirano
country: Italy
facility: Ospedale di Mirano
state: Venice
city: Arezzo
country: Italy
facility: Ospedale S. Donato
city: Bari
country: Italy
facility: AO Policlinico di Bari
city: Cagliari
country: Italy
facility: Ospedale Brotzu
city: Campobasso
country: Italy
facility: Osp. Fondazione Giovanni Paolo II
city: Catanzaro
country: Italy
facility: AO Pugliese Ciaccio
city: Milan
country: Italy
facility: IRCCS San Raffaele
city: Pisa
country: Italy
facility: Fondazione G. Monasterio
city: Rome
country: Italy
facility: Policlinico Casilino
city: Sondrio
country: Italy
facility: Azienda Ospedaliera Valtellina e Valchiavenna
city: Verona
country: Italy
facility: Ospedale Civile Maggiore
city: Lisbon
country: Portugal
facility: Centro Hospitalar Lisboa Norte, Hospital Universitário de Santa Maria
city: Lausanne
country: Switzerland
facility: Lausanne Hospital
Study officials:
affiliation: IRCCS San Raffaele
name: Paolo Della Bella
role: STUDY_DIRECTOR
affiliation: IRCCS San Raffaele
name: Andrea Radinovic
role: STUDY_DIRECTOR
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citation: Della Bella P, Baratto F, Vergara P, Bertocchi P, Santamaria M, Notarstefano P, Calo L, Orsida D, Tomasi L, Piacenti M, Sangiorgio S, Pentimalli F, Pruvot E, De Sousa J, Sacher F, Tritto M, Rebellato L, Deneke T, Romano SA, Nesti M, Gargaro A, Giacopelli D, Peretto G, Radinovic A. Does Timing of Ventricular Tachycardia Ablation Affect Prognosis in Patients With an Implantable Cardioverter Defibrillator? Results From the Multicenter Randomized PARTITA Trial. Circulation. 2022 Jun 21;145(25):1829-1838. doi: 10.1161/CIRCULATIONAHA.122.059598. Epub 2022 Apr 3.
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