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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Sudden Cardiac Death

Intervention / Treatment
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* Device: Subcutaneous ICD Therapy Combined with VT Ablation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S-ICD therapy combined with VT Ablation<br>To evaluate the feasibility and safety of a management approach that incorporates VT-ablation and S-ICD implantation in secondary prevention patients | Device: Subcutaneous ICD Therapy Combined with VT Ablation<br>* S-ICD implantation and VT ablation/substrate modification among patients with a secondary prevention indication for an ICD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subcutaneous ICD Therapy, VT Ablation