Validation Of A New S-ICD Algorithm To Reduce Oversensing Of Dynamic T-Waves In Patients With Brugada Syndrome (DE-08-16)

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, blinded, one arm (repeated measures), non-interventional study. Objective is to setup a 8-center data collection registry between Switzerland, Italy and Belgium.

Study Overview

• Status: Terminated
• Conditions: Brugada Syndrome 1S

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 bradycardia support, cardiac resynchronization or ventricular tachycardia management is not necessary.1 This class IIa recommendation from the 2015 ESC guidelines can often be applied to patients with inherited channelopathies, since these patients usually require decades of ICD therapy without developing a need for any type of pacing support. On the other hand, especially in patients with Brugada Syndrome (BrS), the dynamic nature of ECG morphology may increase the risk for cardiac T-wave oversensing (TWOS), which has also been reported the main cause of inappropriate shocks (IAS) in the general S-ICD population. In order to avoid unnecessary sensing issues with the S-ICD, baseline ECG screening is recommended prior to the implantation procedure. Recently, it has been shown that eligibility failure for S-ICD can occur in up to 13% of patients with an inherited primary arrhythmia syndrome and that patients with BrS present the highest rate of screening failure if compared with other channelopathies.

As of yet, this QRS and T-wave morphology assessment can be done with an algorithm-based automated screening tool (AST) that mimics the sensing set-up process of the S-ICD after implant.

Recently, a novel 9Hz high-pass filter (SMART Pass, available for all EMBLEM S-ICD models) has been introduced to reduce the risk of TWOS with the S-ICD12. This algorithm is only available with the S-ICD sensing mechanism and has not been incorporated in the automated screening software12. Retrospective modelling of inappropriate shock events recorded in the EFFORTLESS registry have shown a reduction in inappropriate shocks by ~80% with SMART Pass compared to the first generation sensing algorithm of the S-ICD13. This was achieved without affecting the detection and the time to therapy for true ventricular arrhythmias.

Prospective data are lacking about the effectiveness of SMART Pass to discriminate T-waves in patients with dynamic ECG morphologies. This may be of particular interest since the occurrence of ECG morphology disturbances is usually difficult to be predicted in individual patients. As such, these data will provide additional guidance to the mandatory screening process for all S-ICD candidates, in particular for those who have a known risk factor for dynamic ECG changes, like patients withBrS. 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.

• Study Type: Observational
• Enrollment (Actual): 126

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, B1090
    • UZ-VUB Brussels
• Italy
  • Cagliari, Italy, 09134
    • Azienda Ospedaliera Brotzu
  • Nuoro, Italy, 08100
    • ATS Sardegna Ospedale San Francesco-ASSL 3 NUORO
  • Pavia, Italy, 27100
    • Fondazione I.R.C.C.S. Policlinico San Matteo di Pavia
• Switzerland
  • Genève, Switzerland, CH - 1205
    • Hôpitaux Universitaires de Genève
  • Lugano, Switzerland, CH-6900
    • Fondazione Cardiocentro Ticino

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Consecutive patients with suspected BrS will be submitted for routine diagnostic ajmaline testing.

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Presence of baseline Brugada type I ECG
2. Presence of structural cardiac abnormalities

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of S-ICD screening failure due to TWOS with and without SMART Pass in patients with ajmaline-induced Brugada Type I ECG.	Rate of S-ICD screening failure due to TWOS after ajmaline challenge with and without SMART Pass in patients with Ajmaline induced Brugada type I ECG.	through study completion, an average of 15 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of S-ICD screening failure with and without SMART Pass in the patients without ajmaline-induced Brugada type-I ECG who manifest a conduction disturbance (i.e. RBBB).	Rate of S-ICD screening failure due to TWOS after ajmaline challenge with and without SMART Pass in patients without Brugada type I EC but with Ajmaline induced ECG conduction disturbances.	through study completion, an average of 15 months

Collaborators and Investigators

• Sponsor: Angelo Auricchio
• Investigators: Principal Investigator: Giulio Conte, Dr., Fondazione Cardiocentro Ticino

Publications and helpful links

General Publications

• Conte G, Cattaneo F, de Asmundis C, Berne P, Vicentini A, Namdar M, Scalone A, Klersy C, Caputo ML, Demarchi A, Ozkartal T, Salghetti F, Casu G, Passarelli I, Mameli S, Shah D, Burri H, De Ferrari G, Brugada P, Auricchio A. Impact of SMART Pass filter in patients with ajmaline-induced Brugada syndrome and subcutaneous implantable cardioverter-defibrillator eligibility failure: results from a prospective multicentre study. Europace. 2022 May 3;24(5):845-854. doi: 10.1093/europace/euab230.

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2017
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: July 30, 2020
• First Submitted That Met QC Criteria: August 6, 2020
• First Posted (Actual): August 7, 2020

Study Record Updates

• Last Update Posted (Actual): August 7, 2020
• Last Update Submitted That Met QC Criteria: August 6, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease; Genetic Diseases, Inborn; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Syndrome; Brugada Syndrome
• Other Study ID Numbers: DE-08-16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No