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

Primary Purpose

Ventricular Fibrillation, Ventricular Tachycardia, Low Cardiac Output

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
EMBLEM S-ICD System
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ventricular Fibrillation

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alabama Cardiovascular Group
  • Huntsville Hospital - The Heart Center, PC
  • Mercy Gilbert Medical Center
  • Mayo Clinic Phoenix
  • Glendale Adventist Medical Center
  • Sharp Grossmont Hospital
  • University of Southern California Hospital
  • Alta Bates Medical Center
  • St. Joseph Hospital
  • Good Samaritan Hospital - San Jose
  • Harbor UCLA Medical Center
  • Yale University School of Medicine
  • Cardiology Physicians PA
  • Baptist Medical Center
  • Florida Hospital
  • Tallahassee Memorial Hospital
  • Emory University Hospital
  • University Hospital
  • CorVita Science Foundation
  • Northwestern Memorial Hospital
  • University of Chicago
  • Northern Indiana Research Alliance - Lutheran Hospital
  • Methodist Hospital of Indianapolis
  • St. Vincent's Hospital
  • University of Iowa Hospitals and Clinics
  • Heartland Cardiology
  • Ochsner Clinic Foundation
  • Advanced Cardiovascular Specialists
  • Peninsula Cardiology Associates
  • St. Joseph Mercy Hospital
  • CardioVascular Institute of Michigan P.C.
  • William Beaumont Hospital
  • Centracare Heart and Vascular Center
  • HealthEast St. Joseph's Hospital
  • North Mississippi Medical Center
  • Mercy Research
  • Cox Health
  • The Nebraska Medical Center
  • HealthCare Partners Cardiology
  • Deborah Heart and Lung Center
  • Cooper Hospital - University Medical Center
  • Cardiovascular Associates of the Delaware Valley
  • Albany Medical Center
  • Northwell Health
  • Beth Israel Medical Center
  • Strong Memorial Hospital of the University of Rochester
  • Memorial Mission Hospital
  • University of North Carolina Hospital
  • Durham VA Medical Center
  • Rex Hospital
  • Aultman Hospital
  • Ohio State University Medical Center
  • The Toledo Hospital
  • Genesis Healthcare System
  • Salem Hospital
  • Sacred Heart Medical Center at Riverbend
  • Abington Memorial Hospital
  • University of Pittsburgh Medical Center
  • AnMed Health
  • Medical University of South Carolina
  • South Texas Veterans Health Care System
  • Trinity Mother Frances Health System
  • University of Utah Hospital and Clinics
  • Centra Stroobants Cardiovascular Center
  • Sentara Norfolk General Hospital
  • Virginia Commonwealth University Health System
  • Evergreen Hospital Medical Center
  • CHI Franciscan Health System
  • St. Mary's Madison
  • Clinique Saint-Jean
  • Universitair Ziekenhuis Gent
  • Institut universitaire de Cardiologie et de Pneumologie de Quebec
  • University Hospital
  • CH Annecy
  • CHU Dijon
  • CHRU de Lille
  • CHU La Timone Hospital
  • CHU Montpellier
  • Hospital de la Pitie-Salpetriere
  • CHRU Hopital Pontchaillou
  • Nouvel Hôpital Civil De Strasbourg
  • Clinique Pasteur
  • CHRU Nancy Brabois
  • Unfallkrankenhaus Berlin Marzahn
  • Deutsches Herzzentrum Berlin
  • University Hospital Frankfurt
  • Universitaetsmedizin Greifswald
  • Universitaetsklinik Eppendorf
  • Universitaetsklinikum Heidelberg
  • University Hospital of Muenster
  • Azienda Ospedaliera Papa Giovanni XXIII
  • Azienda Ospedaliero Universitaria Pisana
  • Azienda Ospedaliera Universitaria Integrata di Verona
  • Academisch Medisch Centrum
  • St. Antonius Ziekenhuis
  • Erasmus MC - University Medical Center Rotterdam
  • Centralny Szpital Kliniczny Uniwerytetu Medycznego
  • Hospital San Lucas
  • Hospital Clinico San Carlos
  • Hospital Virgen De La Salud
  • Hospital Miguel Servet
  • Cardiocentro Ticino
  • University Hospital Zurich
  • Blackpool Victoria NHS Trust Direct
  • Russels Hall Hospital
  • Glenfield Hospital
  • Cardiothoracic Centre
  • St. Bartholomews Hospital
  • Northern General Hospital
  • Southampton University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

Subjects implanted with an EMBLEM S-ICD with rate zones set at 200 bpm and 250 bpm per protocol.

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

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%.
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%.

Full Information

First Posted
April 23, 2015
Last Updated
August 16, 2021
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02433379
Brief Title
Understanding Outcomes With the EMBLEM™ S-ICD in Primary Prevention Patients With Low Ejection Fraction
Acronym
UNTOUCHED
Official Title
Understanding Outcomes With the EMBLEM™ S-ICD in Primary Prevention Patients With Low Ejection Fraction
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 9, 2015 (Actual)
Primary Completion Date
December 6, 2019 (Actual)
Study Completion Date
December 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Fibrillation, Ventricular Tachycardia, Low Cardiac Output

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1173 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Experimental
Arm Description
Subjects implanted with an EMBLEM S-ICD with rate zones set at 200 bpm and 250 bpm per protocol.
Intervention Type
Device
Intervention Name(s)
EMBLEM S-ICD System
Intervention Description
The intervention comprises programming the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) with zone cutoffs at 200 bpm and 250 bmp
Primary Outcome Measure Information:
Title
Percentage of Patients Who Did Not Experience an Inappropriate Shock From Their EMBLEM S-ICD
Description
Primary endpoint: Inappropriate shock free rate from 0 to 540 Days (18-Months) compared to a performance goal of 91.6%.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Percentage of Participants Not Experiencing a System or Procedure Related Complication From 0 to 30 Days
Description
Secondary safety endpoint: Freedom from System and Procedure Related Complications at 30 days compared to a performance goal of 93.8%.
Time Frame
30 days
Title
Percentage of Subjects Free From All-cause Shock From Their EMBLEM S-ICD
Description
Secondary efficacy endpoint: All-Cause Shock Free Rate at 540 days (18-months) compared to a performance goal of 85.8%.
Time Frame
18 months
Other Pre-specified Outcome Measures:
Title
Percentage of Patients Not Experiencing a System or Procedure Related Complication From 0 to 180 Days (6 Months).
Description
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).
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Gold, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lucas Boersma, MD
Organizational Affiliation
St. Antonius Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alabama Cardiovascular Group
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Huntsville Hospital - The Heart Center, PC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Mercy Gilbert Medical Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85297
Country
United States
Facility Name
Mayo Clinic Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Glendale Adventist Medical Center
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Sharp Grossmont Hospital
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
University of Southern California Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-4612
Country
United States
Facility Name
Alta Bates Medical Center
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
St. Joseph Hospital
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Good Samaritan Hospital - San Jose
City
San Jose
State/Province
California
ZIP/Postal Code
95124
Country
United States
Facility Name
Harbor UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Cardiology Physicians PA
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Baptist Medical Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Tallahassee Memorial Hospital
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University Hospital
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
CorVita Science Foundation
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60605
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Northern Indiana Research Alliance - Lutheran Hospital
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
60611
Country
United States
Facility Name
Methodist Hospital of Indianapolis
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
St. Vincent's Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Heartland Cardiology
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Advanced Cardiovascular Specialists
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Peninsula Cardiology Associates
City
Salisbury
State/Province
Maryland
ZIP/Postal Code
21804
Country
United States
Facility Name
St. Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
CardioVascular Institute of Michigan P.C.
City
Roseville
State/Province
Michigan
ZIP/Postal Code
48066
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Centracare Heart and Vascular Center
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
HealthEast St. Joseph's Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
North Mississippi Medical Center
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Mercy Research
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Cox Health
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
The Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
HealthCare Partners Cardiology
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Deborah Heart and Lung Center
City
Browns Mills
State/Province
New Jersey
ZIP/Postal Code
08015
Country
United States
Facility Name
Cooper Hospital - University Medical Center
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Cardiovascular Associates of the Delaware Valley
City
Sewell
State/Province
New Jersey
ZIP/Postal Code
08080
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Northwell Health
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Strong Memorial Hospital of the University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Memorial Mission Hospital
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
University of North Carolina Hospital
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Durham VA Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Rex Hospital
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Aultman Hospital
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
The Toledo Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Genesis Healthcare System
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Salem Hospital
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
Sacred Heart Medical Center at Riverbend
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
AnMed Health
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425-0001
Country
United States
Facility Name
South Texas Veterans Health Care System
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Trinity Mother Frances Health System
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
University of Utah Hospital and Clinics
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Centra Stroobants Cardiovascular Center
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Virginia Commonwealth University Health System
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Evergreen Hospital Medical Center
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
CHI Franciscan Health System
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
St. Mary's Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States
Facility Name
Clinique Saint-Jean
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Institut universitaire de Cardiologie et de Pneumologie de Quebec
City
Ste-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
CH Annecy
City
Annecy
ZIP/Postal Code
74011
Country
France
Facility Name
CHU Dijon
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
CHRU de Lille
City
Lille
Country
France
Facility Name
CHU La Timone Hospital
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
CHU Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Hospital de la Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75151
Country
France
Facility Name
CHRU Hopital Pontchaillou
City
Rennes
Country
France
Facility Name
Nouvel Hôpital Civil De Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
ZIP/Postal Code
31076
Country
France
Facility Name
CHRU Nancy Brabois
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
Unfallkrankenhaus Berlin Marzahn
City
Berlin
ZIP/Postal Code
12687
Country
Germany
Facility Name
Deutsches Herzzentrum Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
University Hospital Frankfurt
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitaetsmedizin Greifswald
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
Universitaetsklinik Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Universitaetsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
University Hospital of Muenster
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Azienda Ospedaliera Papa Giovanni XXIII
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56127
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Integrata di Verona
City
Verona
ZIP/Postal Code
37126
Country
Italy
Facility Name
Academisch Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
ZIP/Postal Code
3430 EM
Country
Netherlands
Facility Name
Erasmus MC - University Medical Center Rotterdam
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Centralny Szpital Kliniczny Uniwerytetu Medycznego
City
Lodz
ZIP/Postal Code
92-213
Country
Poland
Facility Name
Hospital San Lucas
City
Ponce
ZIP/Postal Code
00733
Country
Puerto Rico
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Virgen De La Salud
City
Toledo
ZIP/Postal Code
45004
Country
Spain
Facility Name
Hospital Miguel Servet
City
Zaragoza
Country
Spain
Facility Name
Cardiocentro Ticino
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
Facility Name
University Hospital Zurich
City
Zuerich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Blackpool Victoria NHS Trust Direct
City
Blackpool
ZIP/Postal Code
FY3 8NR
Country
United Kingdom
Facility Name
Russels Hall Hospital
City
Dudley
Country
United Kingdom
Facility Name
Glenfield Hospital
City
Leicester
Country
United Kingdom
Facility Name
Cardiothoracic Centre
City
Liverpool
ZIP/Postal Code
L14 3PE
Country
United Kingdom
Facility Name
St. Bartholomews Hospital
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Northern General Hospital
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom
Facility Name
Southampton University Hospital
City
Southampton
ZIP/Postal Code
S016 6YD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23131066
Citation
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.
Results Reference
background
PubMed Identifier
27943348
Citation
Gold 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 Reference
background
PubMed Identifier
31082539
Citation
Boersma 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 Reference
result
PubMed Identifier
33073614
Citation
Gold 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.
Results Reference
result

Learn more about this trial

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

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