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

Brugada Syndrome 1S Clinical Trial

— DE-08-16  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04504591
• Other study ID #: DE-08-16
• Status: Terminated
• Start date: December 14, 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: August 2020
• Source: Cardiocentro Ticino
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 126
• Est. completion date: June 30, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brugada Syndrome
• Brugada Syndrome 1S
• Syndrome

Locations

Country	Name	City	State
Belgium	UZ-VUB Brussels	Brussels
Italy	Azienda Ospedaliera Brotzu	Cagliari
Italy	ATS Sardegna Ospedale San Francesco-ASSL 3 NUORO	Nuoro
Italy	Fondazione I.R.C.C.S. Policlinico San Matteo di Pavia	Pavia
Switzerland	Hopitaux Universitaires de Genève	Genève
Switzerland	Fondazione Cardiocentro Ticino	Lugano

Sponsors (1)

Lead Sponsor	Collaborator
Angelo Auricchio

Countries where clinical trial is conducted

Belgium,  Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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