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

NCT03622307 | Unknown FDA Device

• 1 other identifier: VT ablation/SICD study
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sudden Cardiac Death

Keywords

Subcutaneous ICD Therapy; VT Ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Appropriate ICD therapy

  24 months

• Inappropriate ICD therapy

  24 months

• Ablation success rates

  24 months

Other Outcomes (2)

• All cause mortality

  24 months

• Cardiac mortality

  24 months

Study Arms (1)

S-ICD therapy combined with VT Ablation

EXPERIMENTAL

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

Interventions

Subcutaneous ICD Therapy Combined with VT Ablation DEVICE

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

S-ICD therapy combined with VT Ablation

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead

MeSH Terms

Conditions

Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Eyal Nof Director Of Invasive Electrophysiology Service Davidai Arrhythmia Center Leviev Heart Center , Sheba Medical Center

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: August 9, 2018
• Study Start: October 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: August 24, 2018

Record last verified: 2018-08