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Arrhythmogenic Substrate in Primary Cardiomyopathies

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ClinicalTrials.gov Identifier: NCT03304847
Recruitment Status : Recruiting
First Posted : October 9, 2017
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Carlo Pappone, IRCCS Policlinico S. Donato

Brief Summary:
This study assesses the value of arrhythmogenic substrate identification and elimination by catheter ablation to prevent recurrent ventricular arrhythmias and sudden cardiac death in a series of selected patients with primary cardiomyopathy and ICD implantation.

Condition or disease Intervention/treatment Phase
Primary Cardiomyopathy Other: ablation Not Applicable

Detailed Description:
The present study is designed as a prospective single center study. All selected patients with implanted ICD to prevent VT/VF recurrence who are referred to the Arrhythmology Department of San Donato Milanese Hospital, for the management of a primary cardiomyopathy fulfilling the inclusion criteria will be enrolled. Primary cardiomyopathies include: - dilated cardiomyopathy (DCM), - arrhythmogenic right ventricular cardiomyopathy (ARVC), - left ventricular non-compaction (LVNC), - early repolarization syndrome (ER), and - hypertrophic cardiomyopathy (HCM). Patients with a family history of BrS, will also be included. Endo-epicardial electroanatomical 3Dmapping and RFA ablation will be systematically performed according to a standardized procedure. Patients will be monitored for at least 3 days after RF ablation. Before hospital discharge, echocardiography and 12-lead ECG will be performed. Patients will be followed-up clinically after the procedure as per normal clinical practice. Follow-up visits will be systematically scheduled at 3, 6, 12, 18 and 24 months. 12-lead ECG and ICD interrogation will be performed at each follow-up visit. Patients will be instructed to immediately contact the center in case of symptoms suggestive of ventricular arrhythmias. Documentation for intercurrent events will be requested and collected. The maximal duration of study participation for the individual patients is two years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Intervention Model Description: single group assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Arrhythmogenic Substrate Assessment in Patients With Primary Cardiomyopathies. A Prospective Follow-up Study
Actual Study Start Date : January 24, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Arm Intervention/treatment
Ablation
Radio-frequency catheter ablation
Other: ablation
radio-frequency applications on arrhythmogenic substrate
Other Name: radio-frequency ablation




Primary Outcome Measures :
  1. Freedom from ventricular fibrillation or ventricular tachycardia [ Time Frame: two years ]
    Survival from recurrent ventricular arrhythmias


Secondary Outcome Measures :
  1. Measurements of Areas of prolonged ventricular potentials obtained by electroamatomocal maps before and after ablation [ Time Frame: 1 day ]
    Electrophysiological characterization of the arrhythmogenic substrate by electroanatomical maps



Information from the National Library of Medicine

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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 affected by cardiomyopathies with and without documented family history of BrS;
  • Presence of symptoms attributable to VA and/or presenting documented arrhythmic episodes;
  • Patients with an ICD already implanted;
  • Patients referred to the centre for an electrophysiological study and indication for a potential concomitant radio-frequency catheter ablation (RFA) of ventricular tachycardia (VT) or ventricular fibrillation (VF);
  • Age ≥ 18;
  • Willingness to attend follow-up examinations;
  • Written informed consent for the participation in the trial

Exclusion Criteria:

  • Pregnancy or breast-feeding;
  • Life expectancy < 12 months

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): NCT03304847


Contacts
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Contact: Carlo Pappone, MD +39 02 52774260 carlo.pappone@af-ablation.org

Locations
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Italy
IRCCS Policlinico S. Donato Recruiting
San Donato Milanese, Milano, Italy, 20097
Contact: Carlo Pappone, MD, PhD    00390252774260    carlo.pappone@af-ablation.org   
Sponsors and Collaborators
IRCCS Policlinico S. Donato
Investigators
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Principal Investigator: Carlo Pappone, MD Chief of Arrhythmology Department

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Responsible Party: Carlo Pappone, Chief of Arrhythmology Deartment, IRCCS Policlinico S. Donato
ClinicalTrials.gov Identifier: NCT03304847     History of Changes
Other Study ID Numbers: IRCCSDonato 01-Cardiomyopathy
First Posted: October 9, 2017    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiomyopathies
Heart Diseases
Cardiovascular Diseases