MADIT S-ICD: Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator

Sponsor

Boston Scientific Corporation (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT02787785

Collaborator

University of Rochester (Other)

Enrollment

Locations

Arms

79.5

Anticipated Duration (Months)

0.8

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The MADIT S-ICD trial is 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.

Condition or Disease	Intervention/Treatment	Phase
Tachycardia Diabetes Mellitus Cardiovascular Disease	Device: Subcutaneous Implantable Cardioverter Defibrillator	N/A

Detailed Description

In this study, subjects will be randomized to receive a subcutaneous implantable cardioverter defibrillator or Conventional Medical Therapy (CMT). Randomization will be stratified by enrolling site, in a 2:1 (S-ICD:CMT) scheme. Length of follow-up for each subject will be dependent on the date of entry into the study, since all subjects will be followed to a common study termination date.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator (MADIT S-ICD)

Actual Study Start Date :

Apr 17, 2017

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Conventional Medical Therapy This arm of the trial continues with their current conventional medical therapy.
Active Comparator: Subcutaneous Implantable Cardioverter Defibrillator This arm of the trial receives a subcutaneous implantable defibrillator.	Device: Subcutaneous Implantable Cardioverter Defibrillator The S-ICD is an entirely subcutaneous implantable cardioverter defibrillator.

Arm

Intervention/Treatment

No Intervention: Conventional Medical Therapy

This arm of the trial continues with their current conventional medical therapy.

Active Comparator: Subcutaneous Implantable Cardioverter Defibrillator

This arm of the trial receives a subcutaneous implantable defibrillator.

Device: Subcutaneous Implantable Cardioverter Defibrillator

The S-ICD is an entirely subcutaneous implantable cardioverter defibrillator.

Outcome Measures

Primary Outcome Measures

All-Cause Mortality [Through study completion,estimated average of 2.6 years follow-up]
This study is event driven so there is no set end date for follow-up or analysis. Subjects will be followed until the statistical boundary is crossed.

Secondary Outcome Measures

All-Cause Mortality in various subgroups [Through study completion,estimated average of 2.6 years follow-up]
This study is event driven so there is no set end date for follow-up or analysis. Subjects will be followed until the statistical boundary is crossed.
Sudden Death in various subgroups [Through study completion,estimated average of 2.6 years follow-up]
This study is event driven so there is no set end date for follow-up or analysis. Subjects will be followed until the statistical boundary is crossed.

Other Outcome Measures

S-ICD Inappropriate shock frequency [Through study completion,estimated average of 2.6 years follow-up]
Pre-specific tertiary statistical analyses will be descriptive and exploratory
S-ICD Inappropriate shock outcomes [Through study completion,estimated average of 2.6 years follow-up]
Pre-specific tertiary statistical analyses will be descriptive and exploratory
S-ICD treated ventricular arrhythmia frequency [Through study completion,estimated average of 2.6 years follow-up]
Pre-specific tertiary statistical analyses will be descriptive and exploratory
S-ICD treated ventricular arrhythmia outcomes [Through study completion,estimated average of 2.6 years follow-up]
Pre-specific tertiary statistical analyses will be descriptive and exploratory
S-ICD device complications [Through study completion, estimated average of 2.6 years follow-up]
Pre-specific tertiary statistical analyses will be descriptive and exploratory

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Heart Center Research, LLC.	Huntsville	Alabama	United States	35801
2	Mayo Clinic- Scottsdale	Scottsdale	Arizona	United States	85259
3	St. Bernard's Medical Center	Jonesboro	Arkansas	United States	72401
4	Glendale Adventist Medical Center	Glendale	California	United States	91206
5	University of Southern California	Los Angeles	California	United States	90033
6	Cedar-Sinai Medical Center	Los Angeles	California	United States	90048
7	Alta Bates Summit Hospital	Oakland	California	United States	94609
8	Huntington Hospital	Pasadena	California	United States	91105
9	Tallahassee Research Institute	Tallahassee	Florida	United States	32308
10	Emory University	Atlanta	Georgia	United States	30308
11	Loyola University Medical Center	Maywood	Illinois	United States	60153
12	University of Iowa	Iowa City	Iowa	United States	52242
13	St. Elizabeth Healthcare	Edgewood	Kentucky	United States	41017
14	University of Louisville	Louisville	Kentucky	United States	40202
15	Advanced Cardiovascular Specialists	Shreveport	Louisiana	United States	71106
16	Tufts Medical Center	Boston	Massachusetts	United States	02111
17	Henry Ford Hospital	Detroit	Michigan	United States	48202
18	Saint Luke's Hospital	Kansas City	Missouri	United States	64111
19	Nebraska Heart Institute	Lincoln	Nebraska	United States	68526
20	Catholic Medical Center	Manchester	New Hampshire	United States	03102
21	Cardiovascular Associates of Delaware Valley	Haddon Heights	New Jersey	United States	08035
22	Northwell Health	Manhasset	New York	United States	11030
23	Strong Memorial / University of Rochester Medical Center	Rochester	New York	United States	14642
24	North Carolina Heart and Vascular	Raleigh	North Carolina	United States	27607
25	Ohio State Wexner Medical Center	Columbus	Ohio	United States	43210
26	Ohio Health Research Institute	Columbus	Ohio	United States	43214
27	Promedica Toledo Hospital	Toledo	Ohio	United States	43606
28	Abington Memorial Hospital	Abington	Pennsylvania	United States	19008
29	Phoenixville Hospital	Phoenixville	Pennsylvania	United States	19460
30	University of Pittsburgh Medical Center - Presbyterian	Pittsburgh	Pennsylvania	United States	15213
31	Erlanger Medical Center	Chattanooga	Tennessee	United States	37403
32	University of Texas, Houston	Houston	Texas	United States	77030
33	Sentara Norfolk General	Norfolk	Virginia	United States	23507
34	Virginia Commonwealth University	Richmond	Virginia	United States	23298
35	University of Washington	Seattle	Washington	United States	98195
36	PeaceHealth Southwest Medical Center	Vancouver	Washington	United States	98664
37	Medizinische Hochschule Hannover	Hannöver	Niedersachsen	Germany	30625
38	Unfallkrankenhaus Berlin	Berlin		Germany	12683
39	Universitaetsklinik Eppendorf	Hamburg		Germany	20246
40	Hadassah Hebrew University Medical Center	Jerusalem		Israel
41	Kaplan Medical Center	Rechovot		Israel	76100
42	Tel Aviv Sourasky Medical Center	Tel Aviv		Israel	6423906
43	Azienda Ospedaliera Ospedale Niguarda CA Granda	Milano	Niguarda	Italy	20162
44	Azienda Ospedaliera Universitaria	Verona		Italy	37126
45	UMC Utrecht	Utrecht	CX	Netherlands	3584
46	Academisch Medisch Centrum	Amsterdam	NH	Netherlands	1105AZ
47	Hospital Universitario Miguel Servet	Zaragosa	Aragon	Spain	50009
48	University of Navarra, Department of Cardiology	Pamplona	Navarra	Spain	31008
49	University Hospital Zurich	Zürich		Switzerland