Subcutaneous ICD Therapy Combined With VT Ablation for the Secondary Prevention of Sudden Cardiac Death

Sheba Medical Center30 enrolled

Overview

This study evaluates the feasibility and safety of a management approach that incorporates VT-ablation and S-ICD implantation in secondary prevention patients. This is a single arm prospective study with 30 patients eligible for implantation of an ICD for the secondary prevention of sudden cardiac death.

The subcutaneous ICD (S-ICD) is a system without transvenous leads that has been proven to safely provide defibrillation for patients at risk of sudden cardiac death due to ventricular tachyarrhythmias. However this system is currently not able to perform anti tachycardia pacing (ATP) which can terminate some VT, thus avoiding painful shocks. Ideally slow VT should be managed with RF ablation while fast VT causing hemodynamic consequences should be treated with ICD shocks combined with medications. Typically, ICDs in secondary prevention patients are programmed to intervene at 10 msec at least above the clinical VT. In cases of hemodynamically stable VT this can result in unnecessary therapies and lead to ICD shocks. S-ICD can safely manage fast VTs while slower hemodynamically VTs can be managed with ablation. This approach can avoid transvenous ICD related complications and unnecessary ICD interventions such as ATP which can accelerate VT to ICD shock zone. However, the benefit of this management strategy compared to conventional transvenous ICD programming has not been studied in patients who receive the device for the secondary prevention of sudden cardiac death.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sudden Cardiac Death

Interventions

Subcutaneous ICD Therapy Combined with VT AblationDEVICE

S-ICD implantation and VT ablation/substrate modification among patients with a secondary prevention indication for an ICD

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Any scar related sustained VT or VF * Class I, IIa, or IIb indication for secondary prevention ICD therapy per ESC Guidelines * Age ≥ 22 years on a date of consent * LVEF ≤ 40% * Positive ECG screening for S-ICD Exclusion Criteria: * A requirement for antibradycardia pacing or CRTD * Subjects with an existing ICD, CRT, CRT-D, or pacemaker device. * Contraindications for S-ICD implantation * Contraindications for VT ablation * Serious known concomitant disease with a life expectancy of \< 1 year * Elderly patients \>80 years of age * NYHA class IV or need for mechanical LV support (ECMO) * Pregnancy or nursing * Unwilling or unable to give informed consent

Outcomes

Primary Outcomes

arrhythmic event

Occurrence of treated arrhythmic event (appropriate and inappropriate). The primary endpoint will be assessed by patient interview, clinical examination, and regularly scheduled SICD interrogation during follow-up

Time frame: 24 months

Secondary Outcomes

Appropriate ICD therapy

Rate of appropriate ICD therapy (defined as a shock therapy for ventricular tachycardia or fibrillation). This will be assessed by patient interview and regularly scheduled ICD interrogation during follow-up.

Time frame: 24 months

Inappropriate ICD therapy

Rate of inappropriate therapy (defined as any ICD shock delivered for Non-VT event). This will be assessed by patient interview and regularly scheduled ICD interrogation during follow-up.

Time frame: 24 months

Ablation success rates

Rate of ablation success (defined as absence of Ventricular Arrhythmia). This will be assessed by patient interview and regularly scheduled ICD interrogation during follow-up.

Time frame: 24 months

Data from ClinicalTrials.gov

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