Back to resultsDoes Timing of VT Ablation Affect Prognosis in Patients With an Implantable Cardioverter-defibrillator? (PARTITA)
Primary Purpose
Ventricular Tachycardias
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Immediate radiofrequency ablation of ventricular tachycardia
Radiofrequency ablation of ventricular tachycardia
Sponsored by
About this trial
This is an interventional treatment trial for Ventricular Tachycardias focused on measuring ICD shocks, Ventricular tachycardias ablation, Timing of ablation, Electrical storm, Arrhythmic storm
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
Sites / Locations
- Brussels Heart Center
- IKEM Hospital
- Hôpital cardiologique du Haut-LévêqueRecruiting
- Herz und Gefass KlinikRecruiting
- Ospedale di DesioRecruiting
- Ospedale di MontebellunaRecruiting
- Ospedale Mater DominiRecruiting
- Azienda Ospedaliera Sant'Antonio AbateRecruiting
- Ospedale di Mirano
- Ospedale S. DonatoRecruiting
- AO Policlinico di Bari
- Ospedale BrotzuRecruiting
- Osp. Fondazione Giovanni Paolo IIRecruiting
- AO Pugliese CiaccioRecruiting
- IRCCS San RaffaeleRecruiting
- Fondazione G. MonasterioRecruiting
- Policlinico CasilinoRecruiting
- Azienda Ospedaliera Valtellina e ValchiavennaRecruiting
- Ospedale Civile MaggioreRecruiting
- Centro Hospitalar Lisboa Norte, Hospital Universitário de Santa MariaRecruiting
- Lausanne HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Group B
Arm Description
Patients will be randomized to a VT ablation procedure immediately after an appropriate ICD shock
Patients will wait until an arrhythmic storm to undergo a VT ablation procedure
Outcomes
Primary Outcome Measures
Occurrence of the first appropriate ICD shock during phase A
Number of patients showing worsening heart failure hospitalizations or deaths from any cause during phase B
Secondary Outcome Measures
Number of patients showing cardiac deaths during phase B
Number of patients showing electrical storm (ES) recurrences during phase B
Number of patients showing VT recurrences during phase B
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01547208
Brief Title
Does Timing of VT Ablation Affect Prognosis in Patients With an Implantable Cardioverter-defibrillator?
Acronym
PARTITA
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Raffaele
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardias
Keywords
ICD shocks, Ventricular tachycardias ablation, Timing of ablation, Electrical storm, Arrhythmic storm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
590 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Patients will be randomized to a VT ablation procedure immediately after an appropriate ICD shock
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Patients will wait until an arrhythmic storm to undergo a VT ablation procedure
Intervention Type
Procedure
Intervention Name(s)
Immediate radiofrequency ablation of ventricular tachycardia
Intervention Description
Radiofrequency ablation of ventricular tachycardia is performed immediately after an appropriate ICD shock
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency ablation of ventricular tachycardia
Intervention Description
Radiofrequency ablation of ventricular tachycardia will be performed after an arrhythmic storm occurs
Primary Outcome Measure Information:
Title
Occurrence of the first appropriate ICD shock during phase A
Time Frame
Event Driven
Title
Number of patients showing worsening heart failure hospitalizations or deaths from any cause during phase B
Time Frame
Two Years
Secondary Outcome Measure Information:
Title
Number of patients showing cardiac deaths during phase B
Time Frame
Two Years
Title
Number of patients showing electrical storm (ES) recurrences during phase B
Time Frame
Two Years
Title
Number of patients showing VT recurrences during phase B
Time Frame
Two Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Radinovic
Email
radinovic.andrea@hsr.it
First Name & Middle Initial & Last Name or Official Title & Degree
Paolo Della Bella
Email
dellabella.paolo@hsr.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Della Bella
Organizational Affiliation
IRCCS San Raffaele
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Andrea Radinovic
Organizational Affiliation
IRCCS San Raffaele
Official's Role
Study Director
Facility Information:
Facility Name
Brussels Heart Center
City
Bruxelles
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaetano Paparella
First Name & Middle Initial & Last Name & Degree
Gaetano Paparella
Facility Name
IKEM Hospital
City
Prague
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josef Kautzner
First Name & Middle Initial & Last Name & Degree
Josef Kautzner
Facility Name
Hôpital cardiologique du Haut-Lévêque
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Jais
First Name & Middle Initial & Last Name & Degree
Pierre Jais
Facility Name
Herz und Gefass Klinik
City
Bad Neustadt An Der Saale
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Deneke
First Name & Middle Initial & Last Name & Degree
Thomas Deneke
Facility Name
Ospedale di Desio
City
Desio
State/Province
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Mantovani
First Name & Middle Initial & Last Name & Degree
Giuseppe Mantovani
Facility Name
Ospedale di Montebelluna
City
Montebelluna
State/Province
Treviso
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diego Vaccari
First Name & Middle Initial & Last Name & Degree
Diego Vaccari
Facility Name
Ospedale Mater Domini
City
Castellanza
State/Province
Varese
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massimo Tritto
First Name & Middle Initial & Last Name & Degree
Massimo Tritto
Facility Name
Azienda Ospedaliera Sant'Antonio Abate
City
Gallarate
State/Province
Varese
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Orsida
First Name & Middle Initial & Last Name & Degree
Daniela Orsida
First Name & Middle Initial & Last Name & Degree
Ivan Caico
Facility Name
Ospedale di Mirano
City
Mirano
State/Province
Venice
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franco Zoppo
First Name & Middle Initial & Last Name & Degree
Franco Zoppo
Facility Name
Ospedale S. Donato
City
Arezzo
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pasquale Notarstefano
First Name & Middle Initial & Last Name & Degree
Pasquale Notarstefano
Facility Name
AO Policlinico di Bari
City
Bari
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Grandinetti
First Name & Middle Initial & Last Name & Degree
Giuseppe Grandinetti
Facility Name
Ospedale Brotzu
City
Cagliari
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gianfranco Tola
First Name & Middle Initial & Last Name & Degree
Gianfranco Tola
Facility Name
Osp. Fondazione Giovanni Paolo II
City
Campobasso
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matteo Santamaria
First Name & Middle Initial & Last Name & Degree
Matteo Santamaria
Facility Name
AO Pugliese Ciaccio
City
Catanzaro
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giampiero Maglia
First Name & Middle Initial & Last Name & Degree
Giampiero Maglia
Facility Name
IRCCS San Raffaele
City
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Radinovic
Email
radinovic.andrea@hsr.it
First Name & Middle Initial & Last Name & Degree
Paolo Della bella
First Name & Middle Initial & Last Name & Degree
Andrea Radinovic
Facility Name
Fondazione G. Monasterio
City
Pisa
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcello Piacenti
First Name & Middle Initial & Last Name & Degree
Marcello Piacenti
Facility Name
Policlinico Casilino
City
Rome
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessio Borrelli
First Name & Middle Initial & Last Name & Degree
Leonardo Calò
First Name & Middle Initial & Last Name & Degree
Alessio Borrelli
Facility Name
Azienda Ospedaliera Valtellina e Valchiavenna
City
Sondrio
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maurizio Moizi
First Name & Middle Initial & Last Name & Degree
Maurizio Moizi
Facility Name
Ospedale Civile Maggiore
City
Verona
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni Morani
First Name & Middle Initial & Last Name & Degree
Giovanni Morani
Facility Name
Centro Hospitalar Lisboa Norte, Hospital Universitário de Santa Maria
City
Lisbon
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Carpinteiro
First Name & Middle Initial & Last Name & Degree
Luis Carpinteiro
Facility Name
Lausanne Hospital
City
Lausanne
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Etienne P Pruvot
First Name & Middle Initial & Last Name & Degree
Etienne Pruvot
12. IPD Sharing Statement
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Does Timing of VT Ablation Affect Prognosis in Patients With an Implantable Cardioverter-defibrillator?
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