Arrhythmogenic Substrate in Primary Cardiomyopathies and/or Channellopathies

Sponsor
IRCCS Policlinico S. Donato (Other)
Overall Status
Recruiting
CT.gov ID
NCT03304847
Collaborator
(none)
35
1
1
70.2
0.5

Study Details

Study Description

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/or channellopaties with ICD implantation.

Condition or Disease Intervention/Treatment Phase
  • Other: ablation
N/A

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).Channellopaties incude - Long QT syndrome and J-wave syndrome) Patients with or without 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
35 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
single group assignmentsingle group assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Arrhythmogenic Substrate Assessment in Patients With Primary Cardiomyopathies and/or Channellopaties With and Without History of Brugada Syndrome: A Prospective Follow-up Study
Actual Study Start Date :
Jan 24, 2018
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Ablation

Radio-frequency catheter ablation

Other: ablation
radio-frequency applications on arrhythmogenic substrate
Other Names:
  • radio-frequency ablation
  • Outcome Measures

    Primary Outcome Measures

    1. Freedom from ventricular fibrillation or ventricular tachycardia [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 [1 day]

      Electrophysiological characterization of the arrhythmogenic substrate by electroanatomical maps

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients affected by cardiomyopathies and/or channellopaties (long QT syndrome and J-wave syndrome) 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IRCCS Policlinico S. Donato San Donato Milanese Milano Italy 20097

    Sponsors and Collaborators

    • IRCCS Policlinico S. Donato

    Investigators

    • Principal Investigator: Carlo Pappone, MD, Chief of Arrhythmology Department

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Carlo Pappone, Chief of Arrhythmology Deartment, IRCCS Policlinico S. Donato
    ClinicalTrials.gov Identifier:
    NCT03304847
    Other Study ID Numbers:
    • IRCCSDonato 01-Cardiomyopathy
    First Posted:
    Oct 9, 2017
    Last Update Posted:
    Apr 29, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 29, 2021