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Understanding Outcomes With the EMBLEM™ S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED)

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ClinicalTrials.gov Identifier: NCT02433379
Recruitment Status : Completed
First Posted : May 5, 2015
Results First Posted : January 8, 2021
Last Update Posted : August 17, 2021
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
This study assesses the 18-month incidence of inappropriate shocks in subjects implanted with the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) for primary prevention of sudden cardiac death. Devices are to be programmed with zone cutoffs at 200 bpm and 250 bmp in order to mimic the programming settings for transvenous ICDs in the MADIT RIT study. The incidence of inappropriate S-ICD shocks will be compared to the incidence of inappropriate shocks observed in the MADIT RIT study.

Condition or disease Intervention/treatment Phase
Ventricular Fibrillation Ventricular Tachycardia Low Cardiac Output Device: EMBLEM S-ICD System Not Applicable

Detailed Description:

Implantable cardioverter defibrillator (ICD) therapy is highly effective for reducing mortality in patients with clinical markers for elevated risk for ventricular arrhythmias. However, inappropriate shocks and unnecessary appropriate shocks remain an important side effect that can significantly affect an ICD recipient's quality of life and may be deleterious to the myocardium.

The MADIT RIT study demonstrated that the incidence of inappropriate and unnecessary appropriate ICD therapy can be reduced in primary prevention patients through two different programming strategies: 1) High Rate Zone Cutoff, i.e., raising the lowest rate detection cutoff to 200 bpm; and 2) Delayed Therapy Initiation, i.e., increasing the time to therapy initiation to 60 seconds for arrhythmias detected between 170-199 bpm and 12.5 seconds between 200-249 bpm. Both strategies effectively reduced the amount of ICD therapy delivered when compared to conventional programming, where the lowest rate detection cutoff was 170 bpm and the delay to therapy initiation was programmed to 2.5 seconds. Importantly, neither treatment arm was associated with significantly increased syncope or mortality. The results of MADIT RIT established preferred device settings for reducing shocks in transvenous ICD (TV-ICD) patients with a primary prevention indication.

Preferred settings for subcutaneous ICDs, however, have not been established with data from prospective studies. The UNTOUCHED study will test a programming scheme designed to minimize inappropriate and unnecessary shocks in patients who have an indication for primary prevention of sudden cardiac death and low ejection fraction. Although S-ICD programming options do not permit exact replication of the programmed settings previously shown to reduce shocks in the MADIT RIT treatment arms, key elements are combined into the UNTOUCHED settings to be tested in this protocol. It is hypothesized that despite the lack of anti-tachycardia pacing, the EMBLEM S-ICD settings utilized in this study will result in an overall shock incidence similar to that observed in ICD patients from MADIT RIT.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1173 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Understanding Outcomes With the EMBLEM™ S-ICD in Primary Prevention Patients With Low Ejection Fraction
Actual Study Start Date : June 9, 2015
Actual Primary Completion Date : December 6, 2019
Actual Study Completion Date : December 6, 2019


Arm Intervention/treatment
Experimental: Single Arm
Subjects implanted with an EMBLEM S-ICD with rate zones set at 200 bpm and 250 bpm per protocol.
Device: EMBLEM S-ICD System
The intervention comprises programming the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) with zone cutoffs at 200 bpm and 250 bmp




Primary Outcome Measures :
  1. Percentage of Patients Who Did Not Experience an Inappropriate Shock From Their EMBLEM S-ICD [ Time Frame: 18 months ]
    Primary endpoint: Inappropriate shock free rate from 0 to 540 Days (18-Months) compared to a performance goal of 91.6%.


Secondary Outcome Measures :
  1. Percentage of Participants Not Experiencing a System or Procedure Related Complication From 0 to 30 Days [ Time Frame: 30 days ]
    Secondary safety endpoint: Freedom from System and Procedure Related Complications at 30 days compared to a performance goal of 93.8%.

  2. Percentage of Subjects Free From All-cause Shock From Their EMBLEM S-ICD [ Time Frame: 18 months ]
    Secondary efficacy endpoint: All-Cause Shock Free Rate at 540 days (18-months) compared to a performance goal of 85.8%.


Other Outcome Measures:
  1. Percentage of Patients Not Experiencing a System or Procedure Related Complication From 0 to 180 Days (6 Months). [ Time Frame: 6 months ]
    Post-Market Clinical Follow-up (PMCF) Endpoint: Freedom from System and Procedure Related Complications at 180 days (6 months) compared to a performance goal of 85%. This analysis was conducted for two sub-groups of UNTOUCHED Study subjects: 1.) the first 200 subjects implanted with an EMBLEM model A209 device; 2.) the first 200 subjects implanted with an EMBLEM model A219 device. The PMCF analysis prespecified in the study protocol only required a sub-set of the implanted UNTOUCHED Study subjects (i.e., 200 subjects for the EMBLEM A209 analysis and 200 for the EMBLEM A219 analysis; the full study cohort was not required for these two analyses).



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with ischemic or non-ischemic heart disease who meets current guidelines for ICD therapy and intends to undergo a de novo implant procedure for an EMBLEM™ S-ICD (or newer generation BSC S-ICD)
  • Left ventricular ejection fraction ≤ 35%
  • A passing EMBLEM™ S-ICD (or newer generation BSC S-ICD) screening ECG
  • Patient ≥ 21 years of age willing and capable of giving informed consent
  • Patient willing and capable of complying with follow-up visits

Exclusion Criteria:

  • Patient with a history of spontaneous sustained VT or VF
  • Patient with bradycardia pacing indication
  • Patient eligible and scheduled for cardiac resynchronization implant
  • Patient with a previous S-ICD or a previous transvenous pulse generator (pacemaker or defibrillator)
  • Patient in NYHA Class IV documented in the medical records within 90 days before enrollment
  • Patient with life expectancy shorter than 18 months due to any medical condition (e.g., cancer, uremia, liver failure, etc…)
  • Patient receiving hemodialysis within 180 days before to enrollment
  • Patients unable to give consent in person, including patients unable to read or write
  • Patient who is known to be pregnant or plans to become pregnant over the course of the trial
  • Patient unwilling or unable to cooperate with the protocol
  • Participation in concurrent clinical study without prior approval from Boston Scientific
  • Medical status (e.g., hemodynamic conditions ) of the patient doesn't allow programming devices with a conditional shock zone at 200 bpm and a shock zone at 250 bpm, in the judgment of the implanting physician and/or according to (inter) national guidelines

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02433379


Locations
Show Show 110 study locations
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Michael Gold, MD Medical University of South Carolina
Principal Investigator: Lucas Boersma, MD St. Antonius ziekenhuis
  Study Documents (Full-Text)

Documents provided by Boston Scientific Corporation:
Publications of Results:
Other Publications:
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02433379    
Other Study ID Numbers: 91026550
First Posted: May 5, 2015    Key Record Dates
Results First Posted: January 8, 2021
Last Update Posted: August 17, 2021
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Ventricular Fibrillation
Cardiac Output, Low
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes