The objective of this study is to collect clinical data on safety and performance of ACUITY X4® leads when used in a standard clinical setting.
It is a prospective, non-randomized, observational multicenter study evaluating standard of care.
For Post Market Clinical Follow up (PMCF) purposes the 3 month implant success rate, adverse events and basic parameters of the lead will be assessed. The cohort of subjects included in this evaluation will be the first 200 subjects which are indicated for PMCF in Rally X4 to receive an ACUITY X4® lead implant.
Study endpoints:
Phrenic Nerve Stimulation (PNS) related CFR through 6 months post-implant (Defined as: rate of freedom from loss of function or operative system revision due to unacceptable PNS threshold) Lead-related Complication-Free Rate (CFR) from Implant through 3 months post-implant.
Who can participate
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject is willing and capable of providing informed consent
. 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
. 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
. Subject is age 18 or above, or of legal age to give informed consent specific to state and national law
Exclusion criteria
. Subjects with a hypersensitivity to a maximum single dose of 0.51 mg dexamethasone acetate
. 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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Per the implanting physician's discretion, the subject is not a suitable candidate to receive the study device as determined during the implant procedure
. Women of childbearing potential who are or might be pregnant at the time of study enrollment or ACUITY X4® lead implant.
. Subject is unwilling or unable to participate in all scheduled study follow up visits at an approved study center
. Subject does not anticipate being a resident of the area for the scheduled duration of the trial
. Subject's physician does not allow participation