Arrhythmogenic Substrate in Primary Cardiomyopathies and/or Channellopathies

Cardiomyopathy Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy

• NCT number: NCT03304847
• Study type: Interventional
• Source: IRCCS Policlinico S. Donato
• Contact: Carlo Pappone, MD
• Phone: +39 02 52774260
• Email: carlo.pappone@af-ablation.org
• Status: Recruiting
• Phase: N/A
• Start date: January 24, 2018
• Completion date: December 30, 2023