- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03649022
"Ventricular Tachycardia Ablation Registry".
"Ventricular Tachycardia Ablation Registry". Italian Registry of Substrate Mapping and VT Ablation With the Precision Mapping System and Flexability Catheter.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Milan, Italy, 20132
- IRCCS San Raffaele
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Late potential abolition and ventricular tachycardia noninducibility
Time Frame: Intraprocedural
|
Combined procedural endpoint of late potential (LP) abolition and VT noninducibility (endpoint expected in 50% of cases). LP abolition assessed as % of persistent LP area at remap after ablation, compared to the basal activation map. |
Intraprocedural
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Ventricular tachycardia recurrence
Time Frame: 12 months
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Freedom from Ventricular Tachycardia episodes requiring ICD Intervention (shock or Anti-Tachycardia Pacing)
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12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complications
Time Frame: During hospitalization: starting during the procedure until discharge
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Periprocedural complications
|
During hospitalization: starting during the procedure until discharge
|
Complications
Time Frame: 12 months
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Long term catheter ablation complications
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12 months
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Procedural parameters
Time Frame: Intraprocedural
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Procedure duration measured in minutes
|
Intraprocedural
|
Procedural parameters
Time Frame: Intraprocedural
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Fluoroscopy exposure measured in Gycm2
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Intraprocedural
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Assessment of cardiac mapping system EnSite Precision™ software (St.Jude, now Abbott)
Time Frame: Intraprocedural
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Geometry precision, descriptive
|
Intraprocedural
|
Assessment of cardiac mapping system EnSite Precision™ software (St.Jude, now Abbott)
Time Frame: Intraprocedural
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Mapping accuracy, descriptive
|
Intraprocedural
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Assessment of cardiac mapping system EnSite Precision™ software (St.Jude, now Abbott)
Time Frame: Intraprocedural
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System overall stability, descriptive
|
Intraprocedural
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Assessment of cardiac mapping system EnSite Precision™ software (St.Jude, now Abbott)
Time Frame: Intraprocedural
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Non-recoverable shifts/drifts, descriptive
|
Intraprocedural
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Paolo Della Bella, MD, IRCCS S Raffaele
Publications and helpful links
General Publications
- Priori SG, Blomstrom-Lundqvist C, Mazzanti A, Blom N, Borggrefe M, Camm J, Elliott PM, Fitzsimons D, Hatala R, Hindricks G, Kirchhof P, Kjeldsen K, Kuck KH, Hernandez-Madrid A, Nikolaou N, Norekval TM, Spaulding C, Van Veldhuisen DJ; ESC Scientific Document Group. 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: The Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC). Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC). Eur Heart J. 2015 Nov 1;36(41):2793-2867. doi: 10.1093/eurheartj/ehv316. Epub 2015 Aug 29. No abstract available.
- Themistoclakis S, Raviele A, China P, Pappone C, De Ponti R, Revishvili A, Aliot E, Kuck KH, Hoff PI, Shah D, Almendral J, Manolis AS, Chierchia GB, Oto A, Vatasescu RG, Sinkovec M, Cappato R; Atrial Fibrillation Survey Investigators. Prospective European survey on atrial fibrillation ablation: clinical characteristics of patients and ablation strategies used in different countries. J Cardiovasc Electrophysiol. 2014 Oct;25(10):1074-81. doi: 10.1111/jce.12462. Epub 2014 Jul 8.
- Reddy VY, Reynolds MR, Neuzil P, Richardson AW, Taborsky M, Jongnarangsin K, Kralovec S, Sediva L, Ruskin JN, Josephson ME. Prophylactic catheter ablation for the prevention of defibrillator therapy. N Engl J Med. 2007 Dec 27;357(26):2657-65. doi: 10.1056/NEJMoa065457.
- Silberbauer J, Oloriz T, Maccabelli G, Tsiachris D, Baratto F, Vergara P, Mizuno H, Bisceglia C, Marzi A, Sora N, Guarracini F, Radinovic A, Cireddu M, Sala S, Gulletta S, Paglino G, Mazzone P, Trevisi N, Della Bella P. Noninducibility and late potential abolition: a novel combined prognostic procedural end point for catheter ablation of postinfarction ventricular tachycardia. Circ Arrhythm Electrophysiol. 2014 Jun;7(3):424-35. doi: 10.1161/CIRCEP.113.001239. Epub 2014 May 15.
- Deo R, Albert CM. Epidemiology and genetics of sudden cardiac death. Circulation. 2012 Jan 31;125(4):620-37. doi: 10.1161/CIRCULATIONAHA.111.023838. No abstract available.
- Tung R, Boyle NG, Shivkumar K. Catheter ablation of ventricular tachycardia. Circulation. 2010 Jul 20;122(3):e389-91. doi: 10.1161/CIRCULATIONAHA.110.963371. No abstract available.
- Aliot EM, Stevenson WG, Almendral-Garrote JM, Bogun F, Calkins CH, Delacretaz E, Bella PD, Hindricks G, Jais P, Josephson ME, Kautzner J, Kay GN, Kuck KH, Lerman BB, Marchlinski F, Reddy V, Schalij MJ, Schilling R, Soejima K, Wilber D; European Heart Rhythm Association; European Society of Cardiology; Heart Rhythm Society. EHRA/HRS Expert Consensus on Catheter Ablation of Ventricular Arrhythmias: developed in a partnership with the European Heart Rhythm Association (EHRA), a Registered Branch of the European Society of Cardiology (ESC), and the Heart Rhythm Society (HRS); in collaboration with the American College of Cardiology (ACC) and the American Heart Association (AHA). Europace. 2009 Jun;11(6):771-817. doi: 10.1093/europace/eup098. Epub 2009 May 14. No abstract available.
- Kuck KH, Schaumann A, Eckardt L, Willems S, Ventura R, Delacretaz E, Pitschner HF, Kautzner J, Schumacher B, Hansen PS; VTACH study group. Catheter ablation of stable ventricular tachycardia before defibrillator implantation in patients with coronary heart disease (VTACH): a multicentre randomised controlled trial. Lancet. 2010 Jan 2;375(9708):31-40. doi: 10.1016/S0140-6736(09)61755-4.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OSR-ARITM-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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