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:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT02066467
Eligibility Criteria:
Inclusion Criteria:
1. Subject is willing and capable of providing informed consent
2. Subject is planned to be implanted with an ACUITY X4® lead for left-ventricular pacing and sensing via the coronary venous system in conjunction with a compatible BSC pulse generator
3. Subject is willing and capable of participating in all visits associated with this study at an approved clinical study center and at the intervals defined by this CIP
4. Subject is age 18 or above, or of legal age to give informed consent specific to state and national law
Exclusion Criteria:
1. Subjects with a hypersensitivity to a maximum single dose of 0.51 mg dexamethasone acetate
2. Subject is enrolled in any other concurrent study without prior written approval from 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 RALLY X4 Study (i.e. should not cause additional or missed visits);
* RALLY X4 Study outcome (i.e. involve medications that could affect the heart rate of the subject);
* Conduct of the RALLY X4 Study per GCP/ ISO 14155:2011/ local regulations as applicable
3. Per the implanting physician's discretion, the subject is not a suitable candidate to receive the study device as determined during the implant procedure
4. Women of childbearing potential who are or might be pregnant at the time of study enrollment or ACUITY X4® lead implant.
5. Subject is unwilling or unable to participate in all scheduled study follow up visits at an approved study center
6. Subject does not anticipate being a resident of the area for the scheduled duration of the trial
7. Subject's physician does not allow participation
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Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02066467
Study Brief:
Protocol Section:
NCT02066467