20 and older, any sex, with Heart Failure or Arrhythmias, Cardiac. 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.
Number of Participants With Ventricular Arrhythmia Associated Symptoms - ICD/CRT-D CohortsPrimary· 12 months follow up
Number of Participants with first appropriately treated ventricular arrhythmia (by anti tachycardia pacing \[ATP\] or shock) or life-threatening symptoms associated to ventricular arrhythmia (defined as hemodynamic instability which requires treatment), whichever comes first under MADIT Arm B or C programming conditions in a study population with a majority of Japanese subjects.
Group
Value
95% CI
CRT-D Cohort
3
ICD Cohort
8
Number of Participant Deaths - Pacing CohortPrimary· 12 months follow up
All-cause mortality in subjects with a maximum of 3 risk factors (analyzed for MADIT II data).
Group
Value
95% CI
Pacing Cohort
3
Number of Participant Deaths - Non-Device CohortPrimary· 12 months follow up
All-cause mortality in the subject cohort with 2 to 5 predefined SCD driving risk factors.
Group
Value
95% CI
Non-device Cohort
5
Number of Participant Deaths - ICD/CRT-D CohortsSecondary· 12 months follow up
All-cause mortality for the ICD and the CRT-D cohorts.
Group
Value
95% CI
CRT-D Cohort
5
ICD Cohort
3
Number of Participants With Composite HF Event - ICD/CRT-D/Pacing CohortsSecondary· 12 months follow up
Number of Participants with HF events, which require intravenous (IV) treatment and/or heart failure (HF) related hospitalization, or which led to HF death
Group
Value
95% CI
CRT-D Cohort
16
ICD Cohort
27
Pacing Cohort
9
Number of Participants With Complication - ICD/CRT-D/Pacing CohortsSecondary· 12 months follow up
Complication refers to qualified serious adverse device effects (SADEs) post success implantation, such as re-implant procedure, required invasive procedure related to the device system, pacing exit block, all-cause infection, and death due to therapy failure.
Group
Value
95% CI
CRT-D Cohort
3
ICD Cohort
4
Pacing Cohort
2
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events are collected through study completion, an average of 20 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Actively Enrolled Patients
Serious: 172/354 (49%)
Deaths: 39/354
Serious adverse events (62 terms)
Reaction
System
Actively Enrolled Patients
Dyspnea - Heart Failure
Cardiac disorders
—
Multiple Heart Failure Symptoms
Cardiac disorders
—
Heart Failure Symptoms - Unspecified
Cardiac disorders
—
Pulmonary
Respiratory, thoracic and mediastinal disorders
—
Ventricular Tachycardia (VT)/Monomorphic VT
Cardiac disorders
—
Atrial Fibrillation (AF)
Cardiac disorders
—
Gastrointestinal
Gastrointestinal disorders
—
Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of this observational registry is to collect clinical events and outcome data in 4 different study populations (cohorts), with a majority of Japanese subjects, that are at risk of sudden cardiac death (SCD) and heart failure (HF) events. These event rates will be compared with available published data mainly from Europe and the United States.
Selected Subject Cohorts:
1. Selected subject cohort with criteria for SCD (without spontaneous prior ventricular sustained arrhythmia) and de novo Implantable Cardioverter-Defibrillator (ICD) device treatment.
2. Selected subject cohort with criteria for SCD and widely accepted standard cardiac resynchronization therapy (CRT) indication who received a de novo CRT-Defibrillator (CRT-D) device treatment.
3. Selected subject cohort who are clinically expected to require \>40% right ventricular pacing with a left ventricular ejection fraction (LVEF) ≤50%, any determined New York Heart Association (NYHA) Class, and receiving pacemaker (PM) or CRT-Pacemaker (CRT-P) therapy despite previous device history (de novo, box changes, system revisions or upgrades).
4. Selected subject cohort with criteria for SCD fulfilling European Society of Cardiology (ESC) ICD or CRT-D therapy guidelines (2016) with an LVEF ≤35%, having 2 to 5 predefined SCD risk factors but do not have or had have a cardiac implanted defibrillator, CRT-D, PM, or CRT-P.
The primary endpoint will report on the Composite rate of first appropriately treated ventricular arrhythmia (by anti-tachycardia pacing \[ATP\] or shock) or life-threatening symptoms associated to ventricular arrhythmia (defined as hemodynamic instability which requires treatment), whichever comes first under MADIT RIT Arm B or C programming conditions in a study population with a majority of Japanese subjects. This primary end point is assessed in the ICD/CRT-D implanted patient cohort.
The all-cause mortality in subjects with a maximum of 3 risk factors (analyzed for MADIT II data) will be assessed in the Pacing (PM/CRT-P) patient cohort.
The all-cause mortality will be assessed in the non-implanted subject cohort.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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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: 14 February 2022
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/NCT03185832.