Understanding Outcomes With the EMBLEM™ S-ICD in Primary Prevention Patients With Low Ejection Fraction
UNTOUCHED
1 other identifier
interventional
1,173
13 countries
110
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2015
Longer than P75 for not_applicable
110 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2015
CompletedFirst Posted
Study publicly available on registry
May 5, 2015
CompletedStudy Start
First participant enrolled
June 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 6, 2019
CompletedResults Posted
Study results publicly available
January 8, 2021
CompletedMarch 24, 2025
March 1, 2025
4.5 years
April 23, 2015
November 16, 2020
March 6, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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%.
18 months
Secondary Outcomes (2)
Percentage of Participants Not Experiencing a System or Procedure Related Complication From 0 to 30 Days
30 days
Percentage of Subjects Free From All-cause Shock From Their EMBLEM S-ICD
18 months
Other Outcomes (1)
Percentage of Patients Not Experiencing a System or Procedure Related Complication From 0 to 180 Days (6 Months).
6 months
Study Arms (1)
Single Arm
EXPERIMENTALSubjects implanted with an EMBLEM S-ICD with rate zones set at 200 bpm and 250 bpm per protocol.
Interventions
The intervention comprises programming the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) with zone cutoffs at 200 bpm and 250 bmp
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (110)
Alabama Cardiovascular Group
Birmingham, Alabama, 35205, United States
Huntsville Hospital - The Heart Center, PC
Huntsville, Alabama, 35801, United States
Mercy Gilbert Medical Center
Gilbert, Arizona, 85297, United States
Mayo Clinic Phoenix
Phoenix, Arizona, 85054, United States
Glendale Adventist Medical Center
Glendale, California, 91206, United States
Sharp Grossmont Hospital
La Mesa, California, 91942, United States
University of Southern California Hospital
Los Angeles, California, 90033-4612, United States
Alta Bates Medical Center
Oakland, California, 94609, United States
St. Joseph Hospital
Orange, California, 92868, United States
Good Samaritan Hospital - San Jose
San Jose, California, 95124, United States
Harbor UCLA Medical Center
Torrance, California, 90502, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
Cardiology Physicians PA
Newark, Delaware, 19713, United States
Baptist Medical Center
Jacksonville, Florida, 32207, United States
Florida Hospital
Orlando, Florida, 32803, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
University Hospital
Augusta, Georgia, 30901, United States
CorVita Science Foundation
Chicago, Illinois, 60605, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
Northern Indiana Research Alliance - Lutheran Hospital
Fort Wayne, Indiana, 60611, United States
Methodist Hospital of Indianapolis
Indianapolis, Indiana, 46202, United States
St. Vincent's Hospital
Indianapolis, Indiana, 46260, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Heartland Cardiology
Wichita, Kansas, 67214, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Advanced Cardiovascular Specialists
Shreveport, Louisiana, 71103, United States
Peninsula Cardiology Associates
Salisbury, Maryland, 21804, United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48106, United States
CardioVascular Institute of Michigan P.C.
Roseville, Michigan, 48066, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Centracare Heart and Vascular Center
Saint Cloud, Minnesota, 56303, United States
HealthEast St. Joseph's Hospital
Saint Paul, Minnesota, 55102, United States
North Mississippi Medical Center
Tupelo, Mississippi, 38801, United States
Mercy Research
Springfield, Missouri, 65804, United States
Cox Health
Springfield, Missouri, 65807, United States
The Nebraska Medical Center
Omaha, Nebraska, 68198, United States
HealthCare Partners Cardiology
Las Vegas, Nevada, 89169, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015, United States
Cooper Hospital - University Medical Center
Camden, New Jersey, 08103, United States
Cardiovascular Associates of the Delaware Valley
Sewell, New Jersey, 08080, United States
Albany Medical Center
Albany, New York, 12208, United States
Northwell Health
New Hyde Park, New York, 11040, United States
Beth Israel Medical Center
New York, New York, 10003, United States
Strong Memorial Hospital of the University of Rochester
Rochester, New York, 14642, United States
Memorial Mission Hospital
Asheville, North Carolina, 28801, United States
University of North Carolina Hospital
Chapel Hill, North Carolina, 27599, United States
Durham VA Medical Center
Durham, North Carolina, 27705, United States
Rex Hospital
Raleigh, North Carolina, 27607, United States
Aultman Hospital
Canton, Ohio, 44710, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
The Toledo Hospital
Toledo, Ohio, 43606, United States
Genesis Healthcare System
Zanesville, Ohio, 43701, United States
Salem Hospital
Salem, Oregon, 97301, United States
Sacred Heart Medical Center at Riverbend
Springfield, Oregon, 97477, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
AnMed Health
Anderson, South Carolina, 29621, United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0001, United States
South Texas Veterans Health Care System
San Antonio, Texas, 78229, United States
Trinity Mother Frances Health System
Tyler, Texas, 75701, United States
University of Utah Hospital and Clinics
Salt Lake City, Utah, 84132, United States
Centra Stroobants Cardiovascular Center
Lynchburg, Virginia, 24501, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
Virginia Commonwealth University Health System
Richmond, Virginia, 23219, United States
Evergreen Hospital Medical Center
Kirkland, Washington, 98034, United States
CHI Franciscan Health System
Tacoma, Washington, 98405, United States
St. Mary's Madison
Madison, Wisconsin, 53715, United States
Clinique Saint-Jean
Brussels, 1000, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Institut universitaire de Cardiologie et de Pneumologie de Quebec
Ste-Foy, Quebec, G1V 4G5, Canada
University Hospital
Odense, 5000, Denmark
CH Annecy
Annecy, 74011, France
CHU Dijon
Dijon, 21079, France
CHRU de Lille
Lille, France
CHU La Timone Hospital
Marseille, 13005, France
CHU Montpellier
Montpellier, 34295, France
Hospital de la Pitie-Salpetriere
Paris, 75151, France
CHRU Hopital Pontchaillou
Rennes, France
Nouvel Hôpital Civil De Strasbourg
Strasbourg, 67091, France
Clinique Pasteur
Toulouse, 31076, France
CHRU Nancy Brabois
Vandœuvre-lès-Nancy, 54500, France
Unfallkrankenhaus Berlin Marzahn
Berlin, 12687, Germany
Deutsches Herzzentrum Berlin
Berlin, 13353, Germany
University Hospital Frankfurt
Frankfurt, 60590, Germany
Universitaetsmedizin Greifswald
Greifswald, 17475, Germany
Universitaetsklinik Eppendorf
Hamburg, 20246, Germany
Universitaetsklinikum Heidelberg
Heidelberg, 69120, Germany
University Hospital of Muenster
Münster, 48149, Germany
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, 24127, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56127, Italy
Azienda Ospedaliera Universitaria Integrata di Verona
Verona, 37126, Italy
Academisch Medisch Centrum
Amsterdam, 1105 AZ, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, 3430 EM, Netherlands
Erasmus MC - University Medical Center Rotterdam
Rotterdam, 3015 GD, Netherlands
Centralny Szpital Kliniczny Uniwerytetu Medycznego
Lodz, 92-213, Poland
Hospital San Lucas
Ponce, 00733, Puerto Rico
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Virgen De La Salud
Toledo, 45004, Spain
Hospital Miguel Servet
Zaragoza, Spain
Cardiocentro Ticino
Lugano, 6900, Switzerland
University Hospital Zurich
Zurich, 8091, Switzerland
Blackpool Victoria NHS Trust Direct
Blackpool, FY3 8NR, United Kingdom
Russels Hall Hospital
Dudley, United Kingdom
Glenfield Hospital
Leicester, United Kingdom
Cardiothoracic Centre
Liverpool, L14 3PE, United Kingdom
St. Bartholomews Hospital
London, EC1A 7BE, United Kingdom
Northern General Hospital
Sheffield, S5 7AU, United Kingdom
Southampton University Hospital
Southampton, S016 6YD, United Kingdom
Related Publications (4)
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.
PMID: 23131066BACKGROUNDGold 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.
PMID: 27943348BACKGROUNDBoersma 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.
PMID: 31082539RESULTGold 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.
PMID: 33073614RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study endpoints are compared against a performance goal rather than to a randomized control arm.
Results Point of Contact
- Title
- Paji Vitoff, Manager, Clinical Trials
- Organization
- Boston Scientific
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Gold, MD
Medical University of South Carolina
- PRINCIPAL INVESTIGATOR
Lucas Boersma, MD
St. Antonius Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2015
First Posted
May 5, 2015
Study Start
June 9, 2015
Primary Completion
December 6, 2019
Study Completion
December 6, 2019
Last Updated
March 24, 2025
Results First Posted
January 8, 2021
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share