Clinical trial NCT03649022: "Ventricular Tachycardia Ablation Registry".
Official title: "Ventricular Tachycardia Ablation Registry". Italian Registry of Substrate Mapping and VT Ablation With the Precision Mapping System and Flexability Catheter.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ventricular Tachycardia
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2018-08-28
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Population of patients with defibrillator, indicated to perform catheter ablation of ventricular tachycardia related to substrate scar due to previous MI, previous myocarditis and arrhythmogenic right ventricular dysplasia, idiopathic dilated cardiomyopathy guided by electroanatomic mapping system.

Brief summary: Catheter ablation of Ventricular Tachycardias is a well-established approach in clinical practice in patients with Implantable Cardioverter Defibrillator (ICD) implanted. Previous studies have shown a significant reduction in appropriate shocks (\~ 20%) and a significant reduction in hospitalizations for cardiovascular reasons (\~ 12%) in patients with ischemic heart disease treated with ablation. Recent works have also shown the effectiveness of the ablation procedure using as procedural target the reduction of late potentials. However, actually it is necessary to have an homogenize and accepted mapping scheme in Sinus Rhythm to ablate Ventricular Tachycardias related to scar substrate in patients with:

* Previous MI
* Previous myocarditis
* Arrhythmogenic Right Ventricular Dysplasia (ARVD)
* Idiopathic Dilated Cardiomyopathy (IDCM)

Scope of the registry is to collect data during cardiac mapping in Sinus Rhythm in patients indicated for Ventricular Tachycardia ablation, that will be performed per clinical practice, by using the St. Jude Medical EnSiteTM PrecisionTM mapping system.

The objective of the present registry is: to assess the acute and long-term efficacy of the strategy of substrate abolition (abolishment of complex and late potentials) guided by electroanatomic mapping with Precision software.

Detailed description: This is an Italian multicenter, observational, prospective and retrospective registry.

Data will be collected during enrollment/baseline, procedure, pre-discharge and during the follow-up visits according to the standard practice of participating centers, with mandatory visits at 6 and 12 months. Data can also be collected retrospectively, prior informed consent of the patient.

The planned enrollment duration is approximately 24 months.

Eligibility criteria: Inclusion Criteria:

* Patients with an implanted ICD
* Patients with indication to Ventricular Tachycardia Ablation procedure, supported by EnSite Precision 3D mapping system (previous MI, myocarditis, ARVD, IDCM)
* Age 18 years or more
* Able to provide an informed consent to participate to the registry and available to respect the assessments described in the protocol

Exclusion Criteria:

* Contraindication to anticoagulants
* Presence of thrombi
* Presence of Mitral and Aortic prosthetic valve
* Recent (\<3 months) myocardial infarction or unstable angina or Coronary Artery Bypass
* Pregnant or nursing
* Ventricular Tachycardia caused by reversible pathology
* \< 1 Year life expectancy according to the investigator
* Contraindication to the use of ablation/diagnostic catheters or to cardiac catheterism

Primary outcomes:
measure: Late potential abolition and ventricular tachycardia noninducibility
timeFrame: Intraprocedural
measure: Ventricular tachycardia recurrence
timeFrame: 12 months
Secondary outcomes:
measure: Complications
timeFrame: During hospitalization: starting during the procedure until discharge
measure: Complications
timeFrame: 12 months
measure: Procedural parameters
timeFrame: Intraprocedural
measure: Procedural parameters
timeFrame: Intraprocedural
measure: Assessment of cardiac mapping system EnSite Precision™ software (St.Jude, now Abbott)
timeFrame: Intraprocedural
measure: Assessment of cardiac mapping system EnSite Precision™ software (St.Jude, now Abbott)
timeFrame: Intraprocedural
measure: Assessment of cardiac mapping system EnSite Precision™ software (St.Jude, now Abbott)
timeFrame: Intraprocedural
measure: Assessment of cardiac mapping system EnSite Precision™ software (St.Jude, now Abbott)
timeFrame: Intraprocedural
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele
Study officials:
affiliation: IRCCS S Raffaele
name: Paolo Della Bella, MD
role: PRINCIPAL_INVESTIGATOR
References:
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