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

NCT ID: NCT03622307

Last Updated: 2018-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-31
• Study Completion Date: 2019-10-01

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.

Conditions

Sudden Cardiac Death

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

S-ICD therapy combined with VT Ablation

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

Group Type: EXPERIMENTAL

Subcutaneous ICD Therapy Combined with VT Ablation

Intervention Type: DEVICE

S-ICD implantation and VT ablation/substrate modification among patients with a secondary prevention indication for an ICD

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Eyal Nof

Dr. Eyal Nof Director Of Invasive Electrophysiology Service Davidai Arrhythmia Center Leviev Heart Center , Sheba Medical Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

VT ablation/SICD study

Identifier Type: -

Identifier Source: org_study_id