NCT03622307

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Sudden Cardiac Death

Interventions

Type	Name	Description
DEVICE	Subcutaneous ICD Therapy Combined with VT Ablation	S-ICD implantation and VT ablation/substrate modification among patients with a secondary prevention indication for an ICD

Timeline

• Start date: 2018-10-01
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2018-08-09
• Last updated: 2018-08-24

Regulatory

• FDA-regulated device study