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

Sudden Cardiac Death Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03622307
• Other study ID #: VT ablation/SICD study
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: August 2018
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Death
• Death, Sudden, Cardiac
• Sudden Cardiac Death

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	All cause mortality	Rate of all cause mortality. This will be assessed during patient follow up.	24 months
Other	Cardiac mortality	Rate of all cardiac mortality. This will be assessed during patient follow up.	24 months
Primary	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	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
Secondary	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
Secondary	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