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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03622307
Recruitment Status : Unknown
Verified August 2018 by Dr. Eyal Nof, Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 9, 2018
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Eyal Nof, Sheba Medical Center

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.

Condition or disease Intervention/treatment Phase
Sudden Cardiac Death Device: Subcutaneous ICD Therapy Combined with VT Ablation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Subcutaneous ICD Therapy Combined With VT Ablation for the Secondary Prevention of Sudden Cardiac Death
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 1, 2019

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


Other Outcome Measures:
  1. All cause mortality [ Time Frame: 24 months ]
    Rate of all cause mortality. This will be assessed during patient follow up.

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



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Responsible Party: Dr. Eyal Nof, Dr. Eyal Nof Director Of Invasive Electrophysiology Service Davidai Arrhythmia Center Leviev Heart Center , Sheba Medical Center, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT03622307    
Other Study ID Numbers: VT ablation/SICD study
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018

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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
Keywords provided by Dr. Eyal Nof, Sheba Medical Center:
Subcutaneous ICD Therapy
VT Ablation
Additional relevant MeSH terms:
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Death, Sudden, Cardiac
Death
Pathologic Processes
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden