65 and older, any sex, with Tachycardia or Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
All-Cause MortalityPrimary· 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.
All-Cause Mortality in Various SubgroupsSecondary· 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.
Sudden DeathSecondary· 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.
S-ICD Inappropriate Shock FrequencySecondary· Outcome measured timeframe includes all available follow-up. Median 61 (4, 71) months.
Pre-specific tertiary statistical analyses will be descriptive and exploratory. This describes the number of inappropriate shocks received in the study .
S-ICD Inappropriate Shock OutcomesSecondary· Outcome measured timeframe includes all available follow-up. Median 61 (4, 71) months.
Pre-specific tertiary statistical analyses will be descriptive and exploratory. This describes the percent of participants that received an inappropriate shock.
S-ICD Treated Ventricular Arrhythmia FrequencySecondary· Outcome measured timeframe includes all available follow-up. Median 61 (4, 71) months.
Pre-specific tertiary statistical analyses will be descriptive and exploratory. This describes the number of appropriate shocks received during the study.
S-ICD Treated Ventricular Arrhythmia OutcomesSecondary· Outcome measured timeframe includes all available follow-up. Median 61 (4, 71) months.
Pre-specific tertiary statistical analyses will be descriptive and exploratory. This describes the number of participants that received an appropriate shock.
Time frame: Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07018648 — Clinical Safety and Efficacy Testing of a Medical Device Kardi Ai, an ECG Telemetry Monitoring System
· NA
· recruiting
NCT06637904 — TriVerity™ for Improved Management of Emergency Department (ED) Patients With Suspected Infections
· NA
· recruiting
NCT06892938 — Detection and Classification of Cardiac Rhythm and Atrial Fibrillation Using a Finger-worn Ring
· active not recruiting
NCT06048731 — Enlighten Study: The EV-ICD Post Approval Registry
· active not recruiting
NCT06505668 — Effect of Atenolol Versus Ivabradine on HRV in TRS Patients on Clozapine With Tachycardia: A Randomised Control Trial.
· NA
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boston Scientific Corporation
Last refreshed: 22 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02787785.