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 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
NCT ID:
NCT01128166
Eligibility Criteria:
Inclusion Criteria:
* Age 18 or above, or of legal age to give informed consent specific to state and national law
* Willing and capable of returning for all follow-up visits and emergency care at the investigational center as medically appropriate
* Willing to participate in all testing associated with this clinical investigation at an approved clinical investigational center
* Currently implanted with a COGNIS device (Model N119 or N120, P107, P108)
* Classified as NYHA Class II, III or IV within the last six months
Exclusion Criteria:
* Inability or refusal to sign the Subject Informed Consent
* Inability of refusal to comply with the follow-up schedule
* Documented as pacemaker dependent
* Unable to rest comfortably in a semi-recumbent position for up to 20 minutes
* Implanted with active Medtronic Fidelis lead models: 6930, 6931, 6948 or 6949
* Currently implanted with unipolar RA, RV, or LV leads
* LV sensitivity programmed to less than 0.7 mV AGC
* History of appropriate tachycardia therapy (external or implanted) for rates \< 165 bpm within 1 week prior to enrollment
* Device battery status indicates approximate time to explant \< 2 years
* Likely to undergo lead or PG revision during the course of the study as determined by the investigator
* Receiving regularly scheduled intravenous (IV) inotropic therapy as part of their drug regimen
* Have received heart or lung transplant
* Receiving mechanical circulatory support
* Patients who have been referred or admitted for Hospice care
* A life expectancy of less than 12 months per physician discretion
* Enrolled in any concurrent study without Boston Scientific written approval
* Devices previously converted to the SRD-1 and withdrawn from the study
* Received a sub-pectoral COGNIS implant prior to February 1, 2011 with a dash number listed in Appendix K of the study protocol
* Known pregnancy or plan to become pregnant within the course of the study
* LV offset is programmed to a value greater than zero
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01128166
Study Brief:
Protocol Section:
NCT01128166