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

Sheba Medical Center

Status: Unknown

Conditions: Sudden Cardiac Death

Treatments: Device: Subcutaneous ICD Therapy Combined with VT Ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT03622307

VT ablation/SICD study

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

S-ICD therapy combined with VT Ablation

Experimental group

Description:

To evaluate the feasibility and safety of a management approach that incorporates VT-ablation and S-ICD implantation in secondary prevention patients

Treatment:

Device: Subcutaneous ICD Therapy Combined with VT Ablation