Ventricular FibrillationUNTOUCHEDNCT02433379
Understanding Outcomes With the EMBLEM™ S-ICD in Primary Prevention Patients With Low Ejection Fraction
A study testing EMBLEM S-ICD System in people with Ventricular Fibrillation and Ventricular Tachycardia, run by Boston Scientific Corporation at 110 sites in 13 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Ventricular Fibrillation, Ventricular Tachycardia, Low Cardiac Output
- What is being tested?
- EMBLEM S-ICD System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,173 participants
- Where
- 110 sitesin 13 countries
- Study dates
- 9 Jun 2015to 6 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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…)
Show all 12Show fewer
- 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
Trial locations and contacts
110 sites in 13 countries.
110 sites in 13 countries
United States69 sites
Abington Memorial Hospital
Abington, Pennsylvania, 19001
Albany Medical Center
Albany, New York, 12208
AnMed Health
Anderson, South Carolina, 29621
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48106
Memorial Mission Hospital
Asheville, North Carolina, 28801
Emory University Hospital
Atlanta, Georgia, 30322
University Hospital
Augusta, Georgia, 30901
Alabama Cardiovascular Group
Birmingham, Alabama, 35205
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015
Cooper Hospital - University Medical Center
Camden, New Jersey, 08103
Aultman Hospital
Canton, Ohio, 44710
University of North Carolina Hospital
Chapel Hill, North Carolina, 27599
Medical University of South Carolina
Charleston, South Carolina, 29425-0001
CorVita Science Foundation
Chicago, Illinois, 60605
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
Ohio State University Medical Center
Columbus, Ohio, 43210
Durham VA Medical Center
Durham, North Carolina, 27705
Northern Indiana Research Alliance - Lutheran Hospital
Fort Wayne, Indiana, 60611
Mercy Gilbert Medical Center
Gilbert, Arizona, 85297
Glendale Adventist Medical Center
Glendale, California, 91206
Huntsville Hospital - The Heart Center, PC
Huntsville, Alabama, 35801
Methodist Hospital of Indianapolis
Indianapolis, Indiana, 46202
St. Vincent's Hospital
Indianapolis, Indiana, 46260
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Baptist Medical Center
Jacksonville, Florida, 32207
Evergreen Hospital Medical Center
Kirkland, Washington, 98034
Sharp Grossmont Hospital
La Mesa, California, 91942
HealthCare Partners Cardiology
Las Vegas, Nevada, 89169
University of Southern California Hospital
Los Angeles, California, 90033-4612
Centra Stroobants Cardiovascular Center
Lynchburg, Virginia, 24501
St. Mary's Madison
Madison, Wisconsin, 53715
Yale University School of Medicine
New Haven, Connecticut, 06520
Northwell Health
New Hyde Park, New York, 11040
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Beth Israel Medical Center
New York, New York, 10003
Cardiology Physicians PA
Newark, Delaware, 19713
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Alta Bates Medical Center
Oakland, California, 94609
The Nebraska Medical Center
Omaha, Nebraska, 68198
St. Joseph Hospital
Orange, California, 92868
Florida Hospital
Orlando, Florida, 32803
Mayo Clinic Phoenix
Phoenix, Arizona, 85054
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Rex Hospital
Raleigh, North Carolina, 27607
Virginia Commonwealth University Health System
Richmond, Virginia, 23219
Strong Memorial Hospital of the University of Rochester
Rochester, New York, 14642
CardioVascular Institute of Michigan P.C.
Roseville, Michigan, 48066
William Beaumont Hospital
Royal Oak, Michigan, 48073
Centracare Heart and Vascular Center
Saint Cloud, Minnesota, 56303
HealthEast St. Joseph's Hospital
Saint Paul, Minnesota, 55102
Salem Hospital
Salem, Oregon, 97301
Peninsula Cardiology Associates
Salisbury, Maryland, 21804
University of Utah Hospital and Clinics
Salt Lake City, Utah, 84132
South Texas Veterans Health Care System
San Antonio, Texas, 78229
Good Samaritan Hospital - San Jose
San Jose, California, 95124
Cardiovascular Associates of the Delaware Valley
Sewell, New Jersey, 08080
Advanced Cardiovascular Specialists
Shreveport, Louisiana, 71103
Mercy Research
Springfield, Missouri, 65804
Cox Health
Springfield, Missouri, 65807
Sacred Heart Medical Center at Riverbend
Springfield, Oregon, 97477
CHI Franciscan Health System
Tacoma, Washington, 98405
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308
The Toledo Hospital
Toledo, Ohio, 43606
Harbor UCLA Medical Center
Torrance, California, 90502
North Mississippi Medical Center
Tupelo, Mississippi, 38801
Trinity Mother Frances Health System
Tyler, Texas, 75701
Heartland Cardiology
Wichita, Kansas, 67214
Genesis Healthcare System
Zanesville, Ohio, 43701
France10 sites
CH Annecy
Annecy, 74011
CHU Dijon
Dijon, 21079
CHRU de Lille
Lille
CHU La Timone Hospital
Marseille, 13005
CHU Montpellier
Montpellier, 34295
Hospital de la Pitie-Salpetriere
Paris, 75151
CHRU Hopital Pontchaillou
Rennes
Nouvel Hôpital Civil De Strasbourg
Strasbourg, 67091
Clinique Pasteur
Toulouse, 31076
CHRU Nancy Brabois
Vandœuvre-lès-Nancy, 54500
Germany7 sites
Unfallkrankenhaus Berlin Marzahn
Berlin, 12687
Deutsches Herzzentrum Berlin
Berlin, 13353
University Hospital Frankfurt
Frankfurt, 60590
Universitaetsmedizin Greifswald
Greifswald, 17475
Universitaetsklinik Eppendorf
Hamburg, 20246
Universitaetsklinikum Heidelberg
Heidelberg, 69120
University Hospital of Muenster
Münster, 48149
United Kingdom7 sites
Blackpool Victoria NHS Trust Direct
Blackpool, FY3 8NR
Russels Hall Hospital
Dudley
Glenfield Hospital
Leicester
Cardiothoracic Centre
Liverpool, L14 3PE
St. Bartholomews Hospital
London, EC1A 7BE
Northern General Hospital
Sheffield, S5 7AU
Southampton University Hospital
Southampton, S016 6YD
Italy3 sites
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, 24127
Azienda Ospedaliero Universitaria Pisana
Pisa, 56127
Azienda Ospedaliera Universitaria Integrata di Verona
Verona, 37126
Netherlands3 sites
Academisch Medisch Centrum
Amsterdam, 1105 AZ
St. Antonius Ziekenhuis
Nieuwegein, 3430 EM
Erasmus MC - University Medical Center Rotterdam
Rotterdam, 3015 GD
Spain3 sites
Hospital Clinico San Carlos
Madrid, 28040
Hospital Virgen De La Salud
Toledo, 45004
Hospital Miguel Servet
Zaragoza
Belgium2 sites
Clinique Saint-Jean
Brussels, 1000
Universitair Ziekenhuis Gent
Ghent, 9000
Switzerland2 sites
Cardiocentro Ticino
Lugano, 6900
University Hospital Zurich
Zurich, 8091
Canada1 site
Institut universitaire de Cardiologie et de Pneumologie de Quebec
Ste-Foy, Quebec, G1V 4G5
About this study
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.
Read the 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.
- Being tested
- EMBLEM S-ICD System
- Medical subject headings
- Ventricular Fibrillation, Tachycardia, Ventricular, Cardiac Output, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMBLEM S-ICD SystemDevice
The intervention comprises programming the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) with zone cutoffs at 200 bpm and 250 bmp
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Subjects implanted with an EMBLEM S-ICD with rate zones set at 200 bpm and 250 bpm per protocol. Receives: Device: EMBLEM S-ICD System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Who Did Not Experience an Inappropriate Shock From Their EMBLEM S-ICD
Primary endpoint: Inappropriate shock free rate from 0 to 540 Days (18-Months) compared to a performance goal of 91.6%.
Measured: 18 months
Secondary outcomes (2)
Percentage of Participants Not Experiencing a System or Procedure Related Complication From 0 to 30 Days
Secondary safety endpoint: Freedom from System and Procedure Related Complications at 30 days compared to a performance goal of 93.8%.
Measured: 30 days
Percentage of Subjects Free From All-cause Shock From Their EMBLEM S-ICD
Secondary efficacy endpoint: All-Cause Shock Free Rate at 540 days (18-months) compared to a performance goal of 85.8%.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study start9 Jun 2015
- Primary completion6 Dec 2019
- Study completion6 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ventricular FibrillationStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Gold, MD, Principal investigator, Medical University of South CarolinaLucas Boersma, MD, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433379
- Sponsor's protocol ID
- 91026550
- Acronym
- UNTOUCHED
- Status last verified
- Mar 2025
- First submitted
- 23 Apr 2015
- Last updated
- 24 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Moss AJ, Schuger C, Beck CA, Brown MW, Cannom DS, Daubert JP, Estes NA 3rd, Greenberg H, Hall WJ, Huang DT, Kautzner J, Klein H, McNitt S, Olshansky B, Shoda M, Wilber D, Zareba W; MADIT-RIT Trial Investigators. Reduction in inappropriate therapy and mortality through ICD programming. N Engl J Med. 2012 Dec 13;367(24):2275-83. doi: 10.1056/NEJMoa1211107. Epub 2012 Nov 6.
PubMed 23131066Gold MR, Knops R, Burke MC, Lambiase PD, Russo AM, Bongiorni MG, Deharo JC, Aasbo J, El Chami MF, Husby M, Carter N, Boersma L. The Design of the Understanding Outcomes with the S-ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED). Pacing Clin Electrophysiol. 2017 Jan;40(1):1-8. doi: 10.1111/pace.12994. Epub 2017 Jan 15.
PubMed 27943348Boersma LV, El-Chami MF, Bongiorni MG, Burke MC, Knops RE, Aasbo JD, Lambiase PD, Deharo JC, Russo AM, Dinerman J, Shaik N, Barr CS, Carter N, Appl U, Brisben AJ, Stein KM, Gold MR. Understanding Outcomes with the EMBLEM S-ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED): Clinical characteristics and perioperative results. Heart Rhythm. 2019 Nov;16(11):1636-1644. doi: 10.1016/j.hrthm.2019.04.048. Epub 2019 May 10.
PubMed 31082539Gold MR, Lambiase PD, El-Chami MF, Knops RE, Aasbo JD, Bongiorni MG, Russo AM, Deharo JC, Burke MC, Dinerman J, Barr CS, Shaik N, Carter N, Stoltz T, Stein KM, Brisben AJ, Boersma LVA; UNTOUCHED Investigators*. Primary Results From the Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED) Trial. Circulation. 2021 Jan 5;143(1):7-17. doi: 10.1161/CIRCULATIONAHA.120.048728. Epub 2020 Oct 19.
PubMed 33073614
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Outcomes With the EMBLEM™ S-ICD in Primary Prevention Patients With Low Ejection Fraction
- ClinicalTrials.gov ID
- NCT02433379
- Acronym / sponsor ID
- UNTOUCHED / 91026550
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,173 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2015 (actual)
- Primary completion
- 6 Dec 2019 (actual)
- Study completion
- 6 Dec 2019 (actual)
- First posted
- 5 May 2015 (estimated)
- Results
- Posted 8 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Device: EMBLEM S-ICD SystemSubjects implanted with an EMBLEM S-ICD with rate zones set at 200 bpm and 250 bpm per protocol. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMBLEM S-ICD SystemThe intervention comprises programming the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) with zone cutoffs at 200 bpm and 250 bmp | Device | Single Arm |
Primary outcome
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%.
2 secondary outcomes
Percentage of Participants Not Experiencing a System or Procedure Related Complication From 0 to 30 Days
Time frame: 30 days
Percentage of Subjects Free From All-cause Shock From Their EMBLEM S-ICD
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23131066Moss AJ, Schuger C, Beck CA, Brown MW, Cannom DS, Daubert JP, Estes NA 3rd, Greenberg H, Hall WJ, Huang DT, Kautzner J, Klein H, McNitt S, Olshansky B, Shoda M, Wilber D, Zareba W; MADIT-RIT Trial Investigators. Reduction in inappropriate therapy and mortality through ICD programming. N Engl J Med. 2012 Dec 13;367(24):2275-83. doi: 10.1056/NEJMoa1211107. Epub 2012 Nov 6.
- Background: PubMed 27943348Gold MR, Knops R, Burke MC, Lambiase PD, Russo AM, Bongiorni MG, Deharo JC, Aasbo J, El Chami MF, Husby M, Carter N, Boersma L. The Design of the Understanding Outcomes with the S-ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED). Pacing Clin Electrophysiol. 2017 Jan;40(1):1-8. doi: 10.1111/pace.12994. Epub 2017 Jan 15.
- Results publication: PubMed 31082539Boersma LV, El-Chami MF, Bongiorni MG, Burke MC, Knops RE, Aasbo JD, Lambiase PD, Deharo JC, Russo AM, Dinerman J, Shaik N, Barr CS, Carter N, Appl U, Brisben AJ, Stein KM, Gold MR. Understanding Outcomes with the EMBLEM S-ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED): Clinical characteristics and perioperative results. Heart Rhythm. 2019 Nov;16(11):1636-1644. doi: 10.1016/j.hrthm.2019.04.048. Epub 2019 May 10.
- Results publication: PubMed 33073614Gold MR, Lambiase PD, El-Chami MF, Knops RE, Aasbo JD, Bongiorni MG, Russo AM, Deharo JC, Burke MC, Dinerman J, Barr CS, Shaik N, Carter N, Stoltz T, Stein KM, Brisben AJ, Boersma LVA; UNTOUCHED Investigators*. Primary Results From the Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED) Trial. Circulation. 2021 Jan 5;143(1):7-17. doi: 10.1161/CIRCULATIONAHA.120.048728. Epub 2020 Oct 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Gold, MD principal investigator
Medical University of South Carolina
Lucas Boersma, MD principal investigator
St. Antonius Hospital
110 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMBLEM S-ICD System in people with Ventricular Fibrillation and Ventricular Tachycardia, run by Boston Scientific Corporation at 110 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 110 sites in United States, France, Germany, United Kingdom, Italy and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients Who Did Not Experience an Inappropriate Shock From Their EMBLEM S-ICD (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02433379, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.