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

August 22, 2018 updated by: Dr. Eyal Nof, Sheba Medical Center
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

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
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
Time Frame: 24 months
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
Time Frame: 24 months

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
Time Frame: 24 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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