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

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.

Study Overview

• Status: Unknown
• Conditions: Sudden Cardiac Death
• Intervention / Treatment: Device: Subcutaneous ICD Therapy Combined with VT Ablation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality	Rate of all cause mortality. This will be assessed during patient follow up.	24 months
Cardiac mortality	Rate of all cardiac mortality. This will be assessed during patient follow up.	24 months

Collaborators and Investigators

• Sponsor: Sheba Medical Center

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2018
• Primary Completion (ANTICIPATED): October 1, 2019
• Study Completion (ANTICIPATED): October 1, 2019

Study Registration Dates

• First Submitted: June 5, 2018
• First Submitted That Met QC Criteria: August 4, 2018
• First Posted (ACTUAL): August 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 24, 2018
• Last Update Submitted That Met QC Criteria: August 22, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: VT Ablation; Subcutaneous ICD Therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Heart Arrest; Death; Death, Sudden, Cardiac
• Other Study ID Numbers: VT ablation/SICD study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes