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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03304847
• Other study ID #: IRCCSDonato 01-Cardiomyopathy
• Status: Recruiting
• Phase: N/A
• Start date: January 24, 2018
• Est. completion date: December 30, 2023

Study information

• Verified date: September 2023
• Source: IRCCS Policlinico S. Donato
• Contact: Carlo Pappone, MD
• Phone: +39 02 52774260
• Email: carlo.pappone[@]af-ablation.org
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: December 30, 2023
• Est. primary completion date: October 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy

Intervention

Other:
• ablation
radio-frequency applications on arrhythmogenic substrate

Locations

Country	Name	City	State
Italy	IRCCS Policlinico S. Donato	San Donato Milanese	Milano

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Donato

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from ventricular fibrillation or ventricular tachycardia	Survival from recurrent ventricular arrhythmias	two years
Secondary	Measurements of Areas of prolonged ventricular potentials obtained by electroamatomocal maps before and after ablation	Electrophysiological characterization of the arrhythmogenic substrate by electroanatomical maps	1 day