NCT03185832

Heart Failure and Sudden Cardiac Death Japan Registry

Heart Failure Indication and Sudden Cardiac Death Prevention Trial Japan

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 354 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Heart Failure
• Arrhythmias, Cardiac
• Sudden Cardiac Death

Interventions

Type	Name	Description
DEVICE	CRT-D	This subject cohort is made by all patients enrolled and implanted with defibrillator with CRT capabilities
DEVICE	ICD	This subject cohort is made by all patients enrolled and implanted with defibrillator capabilities
DEVICE	PM / CRT-P	This subject cohort is made by all patients enrolled and implanted with pacemakers with or without CRT capabilities
OTHER	Non-device	Patient enrolled but not implanted with a Defibrillator or Pacemaker

Timeline

• Start date: 2017-07-21
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2017-06-14
• Last updated: 2022-02-14
• Results posted: 2022-02-14

Locations

34 sites across 1 country: Japan

Regulatory

• FDA-regulated device study