Clinical trial NCT03622307: Subcutaneous ICD Therapy Combined With VT Ablation for the Secondary Prevention of Sudden Cardiac Death
Official title: Subcutaneous ICD Therapy Combined With VT Ablation for the Secondary Prevention of Sudden Cardiac Death
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sudden Cardiac Death
Keywords: Subcutaneous ICD Therapy
VT Ablation
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2018-08-09
Enrollment: 30
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: arrhythmic event
timeFrame: 24 months
Secondary outcomes:
measure: Appropriate ICD therapy
timeFrame: 24 months
measure: Inappropriate ICD therapy
timeFrame: 24 months
measure: Ablation success rates
timeFrame: 24 months
Other outcomes:
measure: All cause mortality
timeFrame: 24 months
measure: Cardiac mortality
timeFrame: 24 months
Locations:
Study officials:
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