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
|Condition or disease||Intervention/treatment||Phase|
|Ventricular Fibrillation Ventricular Tachycardia Low Cardiac Output||Device: EMBLEM S-ICD System||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1173 participants|
|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|
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
- 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%.
- 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%.
- 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%.
- 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).
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
|Principal Investigator:||Michael Gold, MD||Medical University of South Carolina|
|Principal Investigator:||Lucas Boersma, MD||St. Antonius ziekenhuis|