Arrhythmogenic Substrate in Primary Cardiomyopathies and/or Channellopathies

NCT03304847 | Unknown DMC

• 1 other identifier: IRCCSDonato 01-Cardiomyopathy
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Freedom from ventricular fibrillation or ventricular tachycardia

  Survival from recurrent ventricular arrhythmias

  two years

Secondary Outcomes (1)

• Measurements of Areas of prolonged ventricular potentials obtained by electroamatomocal maps before and after ablation

  1 day

Study Arms (1)

Ablation

OTHER

Radio-frequency catheter ablation

Other: ablation

Interventions

ablation OTHER

radio-frequency applications on arrhythmogenic substrate

Also known as: radio-frequency ablation

Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (1)

IRCCS Policlinico S. Donato

San Donato Milanese, Milano, 20097, Italy

RECRUITING

MeSH Terms

Conditions

Cardiomyopathies

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Carlo Pappone, MD

  Chief of Arrhythmology Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlo Pappone, MD

CONTACT

+39 02 52774260; carlo.pappone@af-ablation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Arrhythmology Deartment

Model Details: single group assignment

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: October 9, 2017
• Study Start: January 24, 2018
• Primary Completion: October 2, 2023
• Study Completion: December 30, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)