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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02433379
Other study ID # 91026550
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 9, 2015
Est. completion date December 6, 2019

Study information

Verified date November 2020
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1173
Est. completion date December 6, 2019
Est. primary completion date December 6, 2019
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Belgium Clinique Saint-Jean Brussels
Belgium Universitair Ziekenhuis Gent Gent
Canada Institut universitaire de Cardiologie et de Pneumologie de Quebec Ste-Foy Quebec
Denmark University Hospital Odense
France CH Annecy Annecy
France CHU Dijon Dijon
France CHRU de Lille Lille
France CHU La Timone Hospital Marseille
France CHU Montpellier Montpellier
France Hospital de la Pitie-Salpetriere Paris
France CHRU Hopital Pontchaillou Rennes
France Nouvel Hôpital Civil De Strasbourg Strasbourg
France Clinique Pasteur Toulouse
France CHRU Nancy Brabois Vandoeuvre Les Nancy
Germany Deutsches Herzzentrum Berlin Berlin
Germany Unfallkrankenhaus Berlin Marzahn Berlin
Germany University Hospital Frankfurt Frankfurt
Germany Universitaetsmedizin Greifswald Greifswald
Germany Universitaetsklinik Eppendorf Hamburg
Germany Universitaetsklinikum Heidelberg Heidelberg
Germany University Hospital of Muenster Muenster
Italy Azienda Ospedaliera Papa Giovanni XXIII Bergamo
Italy Azienda Ospedaliero Universitaria Pisana Pisa
Italy Azienda Ospedaliera Universitaria Integrata di Verona Verona
Netherlands Academisch Medisch Centrum Amsterdam
Netherlands St. Antonius Ziekenhuis Nieuwegein
Netherlands Erasmus MC - University Medical Center Rotterdam Rotterdam
Poland Centralny Szpital Kliniczny Uniwerytetu Medycznego Lodz
Puerto Rico Hospital San Lucas Ponce
Spain Hospital Clinico San Carlos Madrid
Spain Hospital Virgen De La Salud Toledo
Spain Hospital Miguel Servet Zaragoza
Switzerland Cardiocentro Ticino Lugano
Switzerland University Hospital Zurich Zuerich
United Kingdom Blackpool Victoria NHS Trust Direct Blackpool
United Kingdom Russels Hall Hospital Dudley
United Kingdom Glenfield Hospital Leicester
United Kingdom Cardiothoracic Centre Liverpool
United Kingdom St. Bartholomews Hospital London
United Kingdom Northern General Hospital Sheffield
United Kingdom Southampton University Hospital Southampton
United States Abington Memorial Hospital Abington Pennsylvania
United States Albany Medical Center Albany New York
United States AnMed Health Anderson South Carolina
United States St. Joseph Mercy Hospital Ann Arbor Michigan
United States Memorial Mission Hospital Asheville North Carolina
United States Emory University Hospital Atlanta Georgia
United States University Hospital Augusta Georgia
United States Alabama Cardiovascular Group Birmingham Alabama
United States Deborah Heart and Lung Center Browns Mills New Jersey
United States Cooper Hospital - University Medical Center Camden New Jersey
United States Aultman Hospital Canton Ohio
United States University of North Carolina Hospital Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States CorVita Science Foundation Chicago Illinois
United States Northwestern Memorial Hospital Chicago Illinois
United States University of Chicago Chicago Illinois
United States Ohio State University Medical Center Columbus Ohio
United States Durham VA Medical Center Durham North Carolina
United States Northern Indiana Research Alliance - Lutheran Hospital Fort Wayne Indiana
United States Mercy Gilbert Medical Center Gilbert Arizona
United States Glendale Adventist Medical Center Glendale California
United States Huntsville Hospital - The Heart Center, PC Huntsville Alabama
United States Methodist Hospital of Indianapolis Indianapolis Indiana
United States St. Vincent's Hospital Indianapolis Indiana
United States University of Iowa Hospitals and Clinics Iowa City Iowa
United States Baptist Medical Center Jacksonville Florida
United States Evergreen Hospital Medical Center Kirkland Washington
United States Sharp Grossmont Hospital La Mesa California
United States HealthCare Partners Cardiology Las Vegas Nevada
United States University of Southern California Hospital Los Angeles California
United States Centra Stroobants Cardiovascular Center Lynchburg Virginia
United States St. Mary's Madison Madison Wisconsin
United States Yale University School of Medicine New Haven Connecticut
United States Northwell Health New Hyde Park New York
United States Ochsner Clinic Foundation New Orleans Louisiana
United States Beth Israel Medical Center New York New York
United States Cardiology Physicians PA Newark Delaware
United States Sentara Norfolk General Hospital Norfolk Virginia
United States Alta Bates Medical Center Oakland California
United States The Nebraska Medical Center Omaha Nebraska
United States St. Joseph Hospital Orange California
United States Florida Hospital Orlando Florida
United States Mayo Clinic Phoenix Phoenix Arizona
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States Rex Hospital Raleigh North Carolina
United States Virginia Commonwealth University Health System Richmond Virginia
United States Strong Memorial Hospital of the University of Rochester Rochester New York
United States CardioVascular Institute of Michigan P.C. Roseville Michigan
United States William Beaumont Hospital Royal Oak Michigan
United States Centracare Heart and Vascular Center Saint Cloud Minnesota
United States HealthEast St. Joseph's Hospital Saint Paul Minnesota
United States Salem Hospital Salem Oregon
United States Peninsula Cardiology Associates Salisbury Maryland
United States University of Utah Hospital and Clinics Salt Lake City Utah
United States South Texas Veterans Health Care System San Antonio Texas
United States Good Samaritan Hospital - San Jose San Jose California
United States Cardiovascular Associates of the Delaware Valley Sewell New Jersey
United States Advanced Cardiovascular Specialists Shreveport Louisiana
United States Cox Health Springfield Missouri
United States Mercy Research Springfield Missouri
United States Sacred Heart Medical Center at Riverbend Springfield Oregon
United States CHI Franciscan Health System Tacoma Washington
United States Tallahassee Memorial Hospital Tallahassee Florida
United States The Toledo Hospital Toledo Ohio
United States Harbor UCLA Medical Center Torrance California
United States North Mississippi Medical Center Tupelo Mississippi
United States Trinity Mother Frances Health System Tyler Texas
United States Heartland Cardiology Wichita Kansas
United States Genesis Healthcare System Zanesville Ohio

Sponsors (1)

Lead Sponsor Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Denmark,  France,  Germany,  Italy,  Netherlands,  Poland,  Puerto Rico,  Spain,  Switzerland,  United Kingdom, 

References & Publications (4)

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 Patien — View 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. — View 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 Outco — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Percentage of Patients Not Experiencing a System or Procedure Related Complication From 0 to 180 Days (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). 6 months
Primary 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 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%. 30 days
Secondary 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%. 18 months
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