Heart Failure, Arrhythmias, Cardiac, Sudden Cardiac Death
Conditions
Keywords
Hear failure, Sudden Cardiac Death, Arrhythmia, Implanted device, ICD, CRT
Brief 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.
Interventions
DEVICECRT-D
This subject cohort is made by all patients enrolled and implanted with defibrillator with CRT capabilities
DEVICEICD
This subject cohort is made by all patients enrolled and implanted with defibrillator capabilities
DEVICEPM / CRT-P
This subject cohort is made by all patients enrolled and implanted with pacemakers with or without CRT capabilities
OTHERNon-device
Patient enrolled but not implanted with a Defibrillator or Pacemaker
Sponsors
ICON Clinical Research
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria: 1. Subject is aged 20 or above 2. Subject is willing and capable of providing informed consent 3. Subject is willing and capable of participating in all visits associated with this study at an approved clinical study site and at the intervals defined by this Clinical Investigation Plan (CIP) 4. Measured Ejection fraction value obtained by echocardiography or equivalent method as Standard of Care (SOC): * Device cohorts: within the last 3 months prior to enrolment * Non-device cohort: latest available within the last 12 months prior to enrollment in case there was no documented HF decompensation, myocardial infarction (MI) or revascularization, otherwise within the last 3 months prior to enrollment And 12 lead electrocardiogram (ECG) recording available as SOC: * Device cohorts: pre-implant ECG maximum 45 days before implant; post-implant ECG * Non-device cohort: latest available maximum 12 months prior to enrollment and subject agrees in the data being used for this study General
Exclusion criteria
1. Subject is enrolled in any other concurrent study without prior written approval from Boston Scientific (BSC), with the exception of local mandatory governmental registries and observational studies/registries that are not in conflict and do not affect the following: * Schedule of procedures for the HINODE Study (i.e. should not cause additional or missed visits) * HINODE Study outcome * Conduct of the HINODE Study per Good Clinical Practice /International Standard Organization 14155:2011/local regulations as applicable 2. Device implant revision is scheduled due to unstable result of an implant \<45 days prior enrolment 3. Subjects with more than 5 of the following risk factors: LVEF \<35%, NYHA Class III or IV, left bundle branch block (LBBB) with QRS \> 130 ms or QRS ≥150 ms, renal dysfunction (chronically BUN \>26 mg/dL / ≥9.28 mmol/L), diabetes type I and II, chronic atrial fibrillation (permanent or persistent according to ESC Guideline 2016), prior MI, age \>70 years, smoking today or during last 5 years 4. Subjects with chronic renal disease with chronic BUN ≥50mg/dL or creatinine ≥2.5 mg/dL 5. Subjects with coronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI) within the past three calendar months prior to enrollment 6. Subjects with enzyme-positive myocardial infarction within the past three calendar months prior to enrollment 7. Subjects who are expected to survive for \<1 year with good functional status 8. Subject's physician does not allow participation 9. Subject is not willing and capable of participating in all testing or visits associated with this clinical study at an approved clinical study center and at the intervals defined by this CIP 10. Unwilling to sign the consent for participation 11. Women of childbearing potential who are or might be pregnant at the time of study enrolment 12. ICD and CRT-D cohorts: implanted with a non-BSC device system. PM/CRT-P cohorts: implanted with a non-BSC pulse generator device. Additional eligibility criteria apply to each cohort
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Ventricular Arrhythmia Associated Symptoms - ICD/CRT-D Cohorts | 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. |
| Number of Participant Deaths - Pacing Cohort | 12 months follow up | All-cause mortality in subjects with a maximum of 3 risk factors (analyzed for MADIT II data). |
| Number of Participant Deaths - Non-Device Cohort | 12 months follow up | All-cause mortality in the subject cohort with 2 to 5 predefined SCD driving risk factors. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participant Deaths - ICD/CRT-D Cohorts | 12 months follow up | All-cause mortality for the ICD and the CRT-D cohorts. |
| Number of Participants With Composite HF Event - ICD/CRT-D/Pacing Cohorts | 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 |
| Number of Participants With Complication - ICD/CRT-D/Pacing Cohorts | 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. |
Countries
Japan
Participant flow
Recruitment details
The first subject was enrolled on 21 July 2017 and the last subject follow-up occurred on 14 September 2020. Study completion date, defined as the date the final participant was examined or received an intervention for purposes of final collection of data for the primary and secondary outcome measures and adverse events, is 1 December 2020. A total of 354 subjects across 34 centers in Japan were enrolled and assigned to a study cohort.
Pre-assignment details
Out of 357 enrolled patients, 3 did not meet eligibility criteria and were considered consent ineligible.
Participants by arm
| Arm | Count |
|---|---|
| CRT-D Cohort This subject cohort is made by all patients enrolled and implanted with defibrillator with CRT capabilities | 69 |
| ICD Cohort This subject cohort is made by all patients enrolled and implanted with defibrillator capabilities | 102 |
| Pacing Cohort This subject cohort is made by all patients enrolled and implanted with pacemakers with or without CRT capabilities | 68 |
| Non-device Cohort Patient enrolled but not implanted with a Defibrillator or Pacemaker | 115 |
| Total | 354 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 9 | 14 | 9 | 7 |
| Overall Study | Withdrawn - vital status available | 0 | 1 | 1 | 4 |
Baseline characteristics
| Characteristic | ICD Cohort | Pacing Cohort | Non-device Cohort | Total | CRT-D Cohort |
|---|---|---|---|---|---|
| Age, Continuous | 68.2 years STANDARD_DEVIATION 10.4 | 75.0 years STANDARD_DEVIATION 10.9 | 68.8 years STANDARD_DEVIATION 11.8 | 69.4 years STANDARD_DEVIATION 11.9 | 66.4 years STANDARD_DEVIATION 13.4 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants | — |
| Region of Enrollment Japan | 102 participants | 68 participants | 115 participants | 354 participants | 69 participants |
| Sex: Female, Male Female | 15 Participants | 24 Participants | 25 Participants | 86 Participants | 22 Participants |
| Sex: Female, Male Male | 87 Participants | 44 Participants | 90 Participants | 268 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 39 / 354 |
| other Total, other adverse events | 99 / 354 |
| serious Total, serious adverse events | 172 / 354 |
Outcome results
Primary
Number of Participant Deaths - Non-Device Cohort
All-cause mortality in the subject cohort with 2 to 5 predefined SCD driving risk factors.
Time frame: 12 months follow up
Population: Subjects 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 risk factors but do not have or have had a cardiac implanted device ICD, CRT-D, PM, or CRT-P.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CRT-D Cohort | Number of Participant Deaths - Non-Device Cohort | 5 Participants |
Primary
Number of Participant Deaths - Pacing Cohort
All-cause mortality in subjects with a maximum of 3 risk factors (analyzed for MADIT II data).
Time frame: 12 months follow up
Population: Subjects who were 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 PM or CRT-Pacemaker (CRT-P) therapy despite previous device history (de novo, box changes, system revisions or upgrades).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CRT-D Cohort | Number of Participant Deaths - Pacing Cohort | 3 Participants |
Primary
Number of Participants With Ventricular Arrhythmia Associated Symptoms - ICD/CRT-D Cohorts
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.
Time frame: 12 months follow up
Population: ICD Cohort: subjects with criteria for sudden cardiac death (SCD) (without spontaneous prior ventricular sustained arrhythmia) and de novo implanted Defibrillator device treatment (ICD).~CRT-D Cohort: subjects with criteria for SCD and widely accepted standard CRT indication who received a de novo implanted CRT D device treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CRT-D Cohort | Number of Participants With Ventricular Arrhythmia Associated Symptoms - ICD/CRT-D Cohorts | 3 Participants |
| ICD Cohort | Number of Participants With Ventricular Arrhythmia Associated Symptoms - ICD/CRT-D Cohorts | 8 Participants |
Secondary
Number of Participant Deaths - ICD/CRT-D Cohorts
All-cause mortality for the ICD and the CRT-D cohorts.
Time frame: 12 months follow up
Population: ICD Cohort: subjects with criteria for SCD (without spontaneous prior ventricular sustained arrhythmia) and de novo implanted Defibrillator device treatment (ICD).~CRT-D Cohort: subject with criteria for SCD and widely accepted standard CRT indication who received a de novo implanted CRT D device treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CRT-D Cohort | Number of Participant Deaths - ICD/CRT-D Cohorts | 5 Participants |
| ICD Cohort | Number of Participant Deaths - ICD/CRT-D Cohorts | 3 Participants |
Secondary
Number of Participants With Complication - ICD/CRT-D/Pacing Cohorts
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.
Time frame: 12 months follow up
Population: ICD Cohort: subjects with criteria for SCD (without spontaneous prior ventricular sustained arrhythmia) and de novo ICD implant.~CRT-D Cohort: subject with criteria for SCD and widely accepted standard CRT indication who received a de novo CRT-D implant.~PM/CRT-P Cohort: subjects who were clinically expected to require \>40% right ventricular pacing with an LVEF ≤50%, any determined New York Heart Association (NYHA) Class, and receiving PM or CRT-P therapy despite previous device history.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CRT-D Cohort | Number of Participants With Complication - ICD/CRT-D/Pacing Cohorts | 3 Participants |
| ICD Cohort | Number of Participants With Complication - ICD/CRT-D/Pacing Cohorts | 4 Participants |
| Pacing Cohort | Number of Participants With Complication - ICD/CRT-D/Pacing Cohorts | 2 Participants |
Secondary
Number of Participants With Composite HF Event - ICD/CRT-D/Pacing Cohorts
Number of Participants with HF events, which require intravenous (IV) treatment and/or heart failure (HF) related hospitalization, or which led to HF death
Time frame: 12 months follow up
Population: ICD Cohort: subjects with criteria for SCD (without spontaneous prior ventricular sustained arrhythmia) and de novo ICD implant.~CRT-D Cohort: subject with criteria for SCD and widely accepted standard CRT indication who received a de novo CRT-D implant.~PM/CRT-P Cohort: subjects who were clinically expected to require \>40% right ventricular pacing with an LVEF ≤50%, any determined New York Heart Association (NYHA) Class, and receiving PM or CRT-P therapy despite previous device history.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CRT-D Cohort | Number of Participants With Composite HF Event - ICD/CRT-D/Pacing Cohorts | 16 Participants |
| ICD Cohort | Number of Participants With Composite HF Event - ICD/CRT-D/Pacing Cohorts | 27 Participants |
| Pacing Cohort | Number of Participants With Composite HF Event - ICD/CRT-D/Pacing Cohorts | 9 Participants |