NCT03106701

Brief Summary

This study represents an extension of a previous study (NCT02641431) on the acute and long-term benefit of epicardial ablation on elimination of both BrS-ECG pattern and VT/VF inducibility in 500 consecutive BrS patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

March 14, 2017

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 10, 2017

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

October 2, 2023

Status Verified

September 1, 2023

Enrollment Period

6.5 years

First QC Date

March 14, 2017

Last Update Submit

September 28, 2023

Conditions

ECG Brugada Pattern

Outcome Measures

Primary Outcomes (3)

  • Type 1 BrS-ECG pattern elimination by epicardial ablation before and after ajmaline test.

    Normalization of ECG pattern after elimination by radio-frequency ablation of all abnormal epicardial potentials

    1 day after ablation

  • VT/VF inducibility

    Programmed stimulation was achieved at twice the diastolic threshold and randomly performed at RV apex and RV outflow tract using up to 3 drive cycle lengths (from 600 to 350ms) and up to three extrastimuli (S2-S4) delivered from the apex and outflow tract of the right ventricle.

    immediately after mapping and ablation

  • Absence of VT/VF

    Absence of VT/VF by ICD interrogation

    1,3,6,12,18,24,36,48,60,72,84,96,108,120 months after ablation

Secondary Outcomes (13)

  • Absence of Br Pattern and RV mechanical abnormalities using echo and cardiac deformation analysis before and after ajmaline test

    3 months

  • Absence of VA episodes at EP study

    3 months

  • Absence of Br Pattern at ajmaline test

    6 months

  • Absence of VA episodes

    6 months

  • Absence of VA episodes

    12 months

  • +8 more secondary outcomes

Study Arms (1)

Ablation

EXPERIMENTAL

Radiofrequency epicardial ablation

Procedure: Ablation

Interventions

AblationPROCEDURE

Epicardial Radiofrequency ablation

Ablation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic BrS patients with typical BrS-related symptoms (cardiac arrest or syncope) or without typical BrS-related symptoms (dizziness, palpitations, presyncope, dyspnea) ICD implantation, spontaneous or ajmaline-induced type 1 Br pattern.

You may not qualify if:

  • Age \< 18 years, prior epicardial ablation, pregnancy, co-morbidities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Policlinico S. Donato

San Donato Milanese, Milano, 20097, Italy

RECRUITING

Related Publications (3)

  • Ciconte G, Santinelli V, Vicedomini G, Borrelli V, Monasky MM, Micaglio E, Giannelli L, Negro G, Giordano F, Mecarocci V, Mazza BC, Locati E, Anastasia L, Calovic Z, Pappone C. Non-invasive assessment of the arrhythmogenic substrate in Brugada syndrome using signal-averaged electrocardiogram: clinical implications from a prospective clinical trial. Europace. 2019 Dec 1;21(12):1900-1910. doi: 10.1093/europace/euz295.

    PMID: 31647530DERIVED

  • Ciconte G, Santinelli V, Brugada J, Vicedomini G, Conti M, Monasky MM, Borrelli V, Castracane W, Aloisio T, Giannelli L, Di Dedda U, Pozzi P, Ranucci M, Pappone C. General Anesthesia Attenuates Brugada Syndrome Phenotype Expression: Clinical Implications From a Prospective Clinical Trial. JACC Clin Electrophysiol. 2018 Apr;4(4):518-530. doi: 10.1016/j.jacep.2017.11.013. Epub 2018 Feb 13.

    PMID: 30067493DERIVED

  • Pappone C, Ciconte G, Manguso F, Vicedomini G, Mecarocci V, Conti M, Giannelli L, Pozzi P, Borrelli V, Menicanti L, Calovic Z, Della Ratta G, Brugada J, Santinelli V. Assessing the Malignant Ventricular Arrhythmic Substrate in Patients With Brugada Syndrome. J Am Coll Cardiol. 2018 Apr 17;71(15):1631-1646. doi: 10.1016/j.jacc.2018.02.022.

    PMID: 29650119DERIVED

MeSH Terms

Conditions

Brugada Syndrome

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseaseGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Carlo Pappone, MD

    IRCCS Policlinico San Donato, Milan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlo Pappone, MD

CONTACT

+39 02 52774260carlo.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
Department Director, MD

Study Record Dates

First Submitted

March 14, 2017

First Posted

April 10, 2017

Study Start

March 14, 2017

Primary Completion

September 28, 2023

Study Completion

December 30, 2023

Last Updated

October 2, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)