Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-24 @ 9:26 PM
NCT ID:
NCT03185832
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT03185832
Study Brief:
Protocol Section:
NCT03185832