Status:

TERMINATED

Validation Of A New S-ICD Algorithm To Reduce Oversensing Of Dynamic T-Waves In Patients With Brugada Syndrome

Lead Sponsor:

Angelo Auricchio

Conditions:

Brugada Syndrome 1S

Eligibility:

All Genders

18+ years

Brief Summary

The main objective of this study will be to assess the efficacy of S-ICD with SMART Pass to discriminate dynamic T-waves amplitudes and morphologies over time. Pilot, multi-centric, prospective, blin...

Detailed Description

The subcutaneous implantable cardioverter-defibrillator (S-ICD) should be considered as an alternative to transvenous defibrillators in patients with an ICD indication when pacing therapy for bradycar...

Eligibility Criteria

Inclusion

  • Male and/or female subjects beyond the ages of ≥18 the time of informed consent;
  • Subjects with suspected BrS;

Exclusion

  • Presence of baseline Brugada type I ECG
  • Presence of structural cardiac abnormalities

Key Trial Info

Start Date :

December 14 2017

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

June 30 2020

Estimated Enrollment :

126 Patients enrolled

Trial Details

Trial ID

NCT04504591

Start Date

December 14 2017

End Date

June 30 2020

Last Update

August 7 2020

Active Locations (6)

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Page 1 of 2 (6 locations)

1

UZ-VUB Brussels

Brussels, Belgium, B1090

2

Azienda Ospedaliera Brotzu

Cagliari, Italy, 09134

3

ATS Sardegna Ospedale San Francesco-ASSL 3 NUORO

Nuoro, Italy, 08100

4

Fondazione I.R.C.C.S. Policlinico San Matteo di Pavia

Pavia, Italy, 27100