TachycardiaMADIT S-ICDNCT02787785
Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator
A study testing Subcutaneous Implantable Cardioverter Defibrillator in people with Tachycardia and Diabetes Mellitus, run by Boston Scientific Corporation at 49 sites in 7 countries.
Trial summary
The MADIT S-ICD trial was designed to evaluate if subjects with a prior myocardial infarction, diabetes mellitus and a relatively preserved ejection fraction of 36-50% will have a survival benefit from receiving a subcutaneous implantable cardioverter defibrillator (S-ICD) when compared to those receiving conventional… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Tachycardia, Diabetes Mellitus, Cardiovascular Disease
- What is being tested?
- Subcutaneous Implantable Cardioverter Defibrillator
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 49 sitesin 7 countries
- Study dates
- 17 Apr 2017to 30 Jun 2023
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years on date of consent
- Diabetes mellitus treated with oral hypoglycemic agents, non-insulin injectable and/or insulin for the past 3 calendar months or longer prior to consent date
- LV ejection fraction (LVEF) of 36-50% documented by imaging (preferably by MRI or echocardiographic methods), within 12 calendar months before consent date and at least 3 calendar months after most recent Myocardial Infarction (MI), percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG).
- One or more clinically documented, enzyme-positive myocardial infarctions, more than 3 calendar months prior to consent date*. (If enzyme information and clinical documentation is not available, there must be a clear evidence of prior silent myocardial infarction identified as either new pathologic Q waves on ECG or imaging documentation of an infarcted area (left ventricular angiography/ nuclear scan/ MRI) Note: MI qualification based on the Universal Definition of MI)
- Qualifying 12-lead ECG within 6 calendar months before consent date and at least 3 calendar months after most recent MI, PCI or CABG. (The qualifying ECG* can be sinus rhythm or atrial fibrillation (patients with persistent or permanent atrial fibrillation should have a controlled ventricular response <100 bpm on consent date) *QRS duration on the qualifying ECG >90 msec)
- Passing S-ICD Screening ECG performed per applicable user's manual on or after the consent date that identifies one or more qualifying S-ICD sensing vectors
Who cannot join
- Ejection fraction >50% or <36% within 12 calendar months prior to consent date and at least 3 calendar months after the most recent MI, PCI or CABG
- Existing guideline based indication for an implantable cardioverter defibrillator (ICD), pacemaker, cardiac resynchronization therapy device (CRT), or cardiac resynchronization therapy device with defibrillator (CRT-D) therapy
- Existing or previously implanted ICD, CRT, CRT-D, or pacemaker device system
- Active infection at the time of consent
- Contraindication for S-ICD implantation according to the S-ICD pulse generator (PG) User's Manual
- Hemodialysis and/or peritoneal dialysis at the time of enrollment
Show all 22Show fewer
- New York Heart Association Class IV in the past 3 calendar months prior to or at the time of consent date
- Coronary artery bypass graft surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within 3 calendar months prior to the consent date
- Enzyme-positive myocardial infarction or silent myocardial infarction diagnosed within 3 calendar months prior to the consent date
- Unstable angina with need for outpatient treatment or hospitalization (change/addition of anti-anginal medication and/or coronary revascularization), within 3 calendar months prior to the consent date
- Angiographic evidence of coronary disease in a patient that is a candidate for coronary revascularization and is likely to undergo CABG or PCI in the next 3 calendar months
- High risk for arterial embolism (e.g. presence of mobile left ventricular thrombus)
- Hemodynamically significant congenital heart disease, aortic valvular heart disease, or amyloid heart disease
- Baseline body mass index > 45 kg/m2
- On a heart transplant list or likely to undergo heart transplant within one calendar year
- Presence of any other disease, other than the subject's cardiac disease, that in the opinion of the investigator is likely to significantly reduce the patient's likelihood of survival for the duration of the trial (e.g. cancer, liver failure).
- Unwillingness or inability to cooperate with the protocol
- Resides at such a distance from the enrolling site so travel to follow-up visits would be unusually difficult
- Reversible causes of heart disease (e.g. viral myocarditis or tachycardia induced cardiomyopathy)
- Participation in other clinical trials (observational registries are allowed with approval from the CDC)
- Does not anticipate residing in the vicinity of the enrolling site for the duration of the trial
- Unwillingness to sign the consent for participation
Trial locations and contacts
49 sites in 7 countries.
49 sites in 7 countries
United States36 sites
Abington Memorial Hospital
Abington, Pennsylvania, 19008
Emory University
Atlanta, Georgia, 30308
Tufts Medical Center
Boston, Massachusetts, 02111
Erlanger Medical Center
Chattanooga, Tennessee, 37403
Ohio State Wexner Medical Center
Columbus, Ohio, 43210
Ohio Health Research Institute
Columbus, Ohio, 43214
Henry Ford Hospital
Detroit, Michigan, 48202
St. Elizabeth Healthcare
Edgewood, Kentucky, 41017
Glendale Adventist Medical Center
Glendale, California, 91206
Cardiovascular Associates of Delaware Valley
Haddon Heights, New Jersey, 08035
University of Texas, Houston
Houston, Texas, 77030
Heart Center Research, LLC.
Huntsville, Alabama, 35801
University of Iowa
Iowa City, Iowa, 52242
St. Bernard's Medical Center
Jonesboro, Arkansas, 72401
Saint Luke's Hospital
Kansas City, Missouri, 64111
Nebraska Heart Institute
Lincoln, Nebraska, 68526
University of Southern California
Los Angeles, California, 90033
Cedar-Sinai Medical Center
Los Angeles, California, 90048
University of Louisville
Louisville, Kentucky, 40202
Catholic Medical Center
Manchester, New Hampshire, 03102
Northwell Health
Manhasset, New York, 11030
Loyola University Medical Center
Maywood, Illinois, 60153
Sentara Norfolk General
Norfolk, Virginia, 23507
Alta Bates Summit Hospital
Oakland, California, 94609
Huntington Hospital
Pasadena, California, 91105
Phoenixville Hospital
Phoenixville, Pennsylvania, 19460
University of Pittsburgh Medical Center - Presbyterian
Pittsburgh, Pennsylvania, 15213
North Carolina Heart and Vascular
Raleigh, North Carolina, 27607
Virginia Commonwealth University
Richmond, Virginia, 23298
Strong Memorial / University of Rochester Medical Center
Rochester, New York, 14642
Mayo Clinic- Scottsdale
Scottsdale, Arizona, 85259
University of Washington
Seattle, Washington, 98195
Advanced Cardiovascular Specialists
Shreveport, Louisiana, 71106
Tallahassee Research Institute
Tallahassee, Florida, 32308
Promedica Toledo Hospital
Toledo, Ohio, 43606
PeaceHealth Southwest Medical Center
Vancouver, Washington, 98664
Germany3 sites
Unfallkrankenhaus Berlin
Berlin, 12683
Universitaetsklinik Eppendorf
Hamburg, 20246
Medizinische Hochschule Hannover
Hannover, Lower Saxony, 30625
Israel3 sites
Hadassah Hebrew University Medical Center
Jerusalem
Kaplan Medical Center
Rehovot, 76100
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
Italy2 sites
Azienda Ospedaliera Ospedale Niguarda CA Granda
Milan, Niguarda, 20162
Azienda Ospedaliera Universitaria
Verona, 37126
Netherlands2 sites
Academisch Medisch Centrum
Amsterdam, North Holland, 1105AZ
UMC Utrecht
Utrecht, CX, 3584
Spain2 sites
University of Navarra, Department of Cardiology
Pamplona, Navarre, 31008
Hospital Universitario Miguel Servet
Zaragoza, Aragon, 50009
About this study
Official title: Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator (MADIT S-ICD)
The MADIT S-ICD trial was designed to evaluate if subjects with a prior myocardial infarction, diabetes mellitus and a relatively preserved ejection fraction of 36-50% will have a survival benefit from receiving a subcutaneous implantable cardioverter defibrillator (S-ICD) when compared to those receiving conventional medical therapy. The trial enrollment was stopped in 2018 due to lower than expected enrollment, all subjects enrolled at that time were followed for approximately 5 years.
Read the detailed description
In this study, subjects were randomized to receive a subcutaneous implantable cardioverter defibrillator or Conventional Medical Therapy (CMT). Randomization was stratified by enrolling site, in a 2:1 (S-ICD:CMT) scheme. Length of follow-up for each subject was dependent on the date of entry into the study, since all subjects were followed to a common study termination date.
- Conditions
- Tachycardia, Diabetes Mellitus, Cardiovascular Disease
- Being tested
- Subcutaneous Implantable Cardioverter Defibrillator
- Keywords
- Subcutaneous, Implantable Cardioverter Defibrillator, MADIT, Diabetes, Myocardial Infarction
- Medical subject headings
- Tachycardia, Diabetes Mellitus, Cardiovascular Diseases, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous Implantable Cardioverter DefibrillatorDevice
The S-ICD is an entirely subcutaneous implantable cardioverter defibrillator.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Medical Therapy | No intervention | This arm of the trial continues with their current conventional medical therapy. |
| Subcutaneous Implantable Cardioverter Defibrillator | Active comparator | This arm of the trial receives a subcutaneous implantable defibrillator. Receives: Device: Subcutaneous Implantable Cardioverter Defibrillator |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-Cause Mortality
The original study design was event driven with the end date expected to be based on crossing the statistical boundary. The trial enrollment was stopped in 2018 due to lower than expected enrollment, all subjects enrolled at that time were followed for approximately 5 years. The outcomes will be analyzed but are no longer statistically powered for conclusions.
Measured: Outcome measured timeframe includes all available follow-up. Median 61 (4, 71) months.
Secondary outcomes (2)
All-Cause Mortality in Various Subgroups
The original study design was event driven with the end date expected to be based on crossing the statistical boundary. The trial enrollment was stopped in 2018 due to lower than expected enrollment, all subjects enrolled at that time were followed for approximately 5 years. The outcomes will be analyzed but are no longer statistically powered for conclusions.
Measured: Outcome measured timeframe includes all available follow-up. Median 61 (4, 71) months.
Sudden Death
The original study design was event driven with the end date expected to be based on crossing the statistical boundary. The trial enrollment was stopped in 2018 due to lower than expected enrollment, all subjects enrolled at that time were followed for approximately 5 years. The outcomes will be analyzed but are no longer statistically powered for conclusions.
Measured: Outcome measured timeframe includes all available follow-up. Median 61 (4, 71) months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study start17 Apr 2017
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
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 (1)Papers the sponsor has linked to this study.
- Other trials for TachycardiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Rochester
- Responsible party
- Sponsor
- Investigators
- Valentina Kutyifa, MD, MSc, PhD, Principal investigator, University of Rochester Heart Research Follow-up Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787785
- Sponsor's protocol ID
- MADIT S-ICD (C1834)
- Acronym
- MADIT S-ICD
- Status last verified
- Aug 2024
- First submitted
- 18 May 2016
- Last updated
- 22 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kutyifa V, Beck C, Brown MW, Cannom D, Daubert J, Estes M, Greenberg H, Goldenberg I, Hammes S, Huang D, Klein H, Knops R, Kosiborod M, Poole J, Schuger C, Singh JP, Solomon S, Wilber D, Zareba W, Moss AJ; MADIT S-ICD Executive Committee. Multicenter Automatic Defibrillator Implantation Trial-Subcutaneous Implantable Cardioverter Defibrillator (MADIT S-ICD): Design and clinical protocol. Am Heart J. 2017 Jul;189:158-166. doi: 10.1016/j.ahj.2017.04.014. Epub 2017 May 4.
PubMed 28625372
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator (MADIT S-ICD)
- ClinicalTrials.gov ID
- NCT02787785
- Acronym / sponsor ID
- MADIT S-ICD / MADIT S-ICD (C1834)
- Conditions
- Tachycardia, Diabetes Mellitus, Cardiovascular Disease
- Keywords
- Subcutaneous, Implantable Cardioverter Defibrillator, MADIT, Diabetes, Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- University of Rochester
- Study start
- 17 Apr 2017 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 1 Jun 2016 (estimated)
- Results
- Posted 22 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The MADIT S-ICD trial was designed to evaluate if subjects with a prior myocardial infarction, diabetes mellitus and a relatively preserved ejection fraction of 36-50% will have a survival benefit from receiving a subcutaneous implantable cardioverter defibrillator (S-ICD) when compared to those receiving conventional medical therapy. The trial enrollment was stopped in 2018 due to lower than expected enrollment, all subjects enrolled at that time were followed for approximately 5 years.
Detailed description
In this study, subjects were randomized to receive a subcutaneous implantable cardioverter defibrillator or Conventional Medical Therapy (CMT). Randomization was stratified by enrolling site, in a 2:1 (S-ICD:CMT) scheme. Length of follow-up for each subject was dependent on the date of entry into the study, since all subjects were followed to a common study termination date.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Medical Therapy | No intervention | –This arm of the trial continues with their current conventional medical therapy. |
| Subcutaneous Implantable Cardioverter Defibrillator | Active comparator | Device: Subcutaneous Implantable Cardioverter DefibrillatorThis arm of the trial receives a subcutaneous implantable defibrillator. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age ≥ 65 years on date of consent
- Diabetes mellitus treated with oral hypoglycemic agents, non-insulin injectable and/or insulin for the past 3 calendar months or longer prior to consent date
- LV ejection fraction (LVEF) of 36-50% documented by imaging (preferably by MRI or echocardiographic methods), within 12 calendar months before consent date and at least 3 calendar months after most recent Myocardial Infarction (MI), percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG).
- One or more clinically documented, enzyme-positive myocardial infarctions, more than 3 calendar months prior to consent date*. (If enzyme information and clinical documentation is not available, there must be a clear evidence of prior silent myocardial infarction identified as either new pathologic Q waves on ECG or imaging documentation of an infarcted area (left ventricular angiography/ nuclear scan/ MRI) Note: MI qualification based on the Universal Definition of MI)
- Qualifying 12-lead ECG within 6 calendar months before consent date and at least 3 calendar months after most recent MI, PCI or CABG. (The qualifying ECG* can be sinus rhythm or atrial fibrillation (patients with persistent or permanent atrial fibrillation should have a controlled ventricular response <100 bpm on consent date) *QRS duration on the qualifying ECG >90 msec)
Key exclusion criteria (22 listed)
- Ejection fraction >50% or <36% within 12 calendar months prior to consent date and at least 3 calendar months after the most recent MI, PCI or CABG
- Existing guideline based indication for an implantable cardioverter defibrillator (ICD), pacemaker, cardiac resynchronization therapy device (CRT), or cardiac resynchronization therapy device with defibrillator (CRT-D) therapy
- Existing or previously implanted ICD, CRT, CRT-D, or pacemaker device system
- Active infection at the time of consent
- Contraindication for S-ICD implantation according to the S-ICD pulse generator (PG) User's Manual
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 |
|---|---|---|
| Subcutaneous Implantable Cardioverter DefibrillatorThe S-ICD is an entirely subcutaneous implantable cardioverter defibrillator. | Device | Subcutaneous Implantable Cardioverter Defibrillator |
Primary outcome
All-Cause Mortality
Time frame: Outcome measured timeframe includes all available follow-up. Median 61 (4, 71) months.
The original study design was event driven with the end date expected to be based on crossing the statistical boundary. The trial enrollment was stopped in 2018 due to lower than expected enrollment, all subjects enrolled at that time were followed for approximately 5 years. The outcomes will be analyzed but are no longer statistically powered for conclusions.
2 secondary outcomes
All-Cause Mortality in Various Subgroups
Time frame: Outcome measured timeframe includes all available follow-up. Median 61 (4, 71) months.
Sudden Death
Time frame: Outcome measured timeframe includes all available follow-up. Median 61 (4, 71) months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28625372Kutyifa V, Beck C, Brown MW, Cannom D, Daubert J, Estes M, Greenberg H, Goldenberg I, Hammes S, Huang D, Klein H, Knops R, Kosiborod M, Poole J, Schuger C, Singh JP, Solomon S, Wilber D, Zareba W, Moss AJ; MADIT S-ICD Executive Committee. Multicenter Automatic Defibrillator Implantation Trial-Subcutaneous Implantable Cardioverter Defibrillator (MADIT S-ICD): Design and clinical protocol. Am Heart J. 2017 Jul;189:158-166. doi: 10.1016/j.ahj.2017.04.014. Epub 2017 May 4.
- 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.
Valentina Kutyifa, MD, MSc, PhD principal investigator
University of Rochester Heart Research Follow-up Program
49 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subcutaneous Implantable Cardioverter Defibrillator in people with Tachycardia and Diabetes Mellitus, run by Boston Scientific Corporation at 49 sites in 7 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 6 inclusion and 22 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 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States, Germany, Israel, Italy, Netherlands and 2 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 22 Aug 2024). 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?
All-Cause Mortality (time frame: Outcome measured timeframe includes all available follow-up. Median 61 (4, 71) 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 NCT02787785, which also lists 1 linked publication.
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 22 Aug 2024.