CHF heart failure
Conditions
Interventions
None listed
Sponsors
Boston Scientific Cooperation International
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Subject is willind and capable of providing informed consent - Subject is planned to be implanted with an ACUITY X$ 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 os age 18 or above, or of legal age to give informed consent specific to state and national law
Exclusion criteria
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: * 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 - Per the implanting physician's discretion, the subject is not a sauitable 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 - Subject is unwillingor 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints: - PNS-related Complication-Free Rate (CFR) through 6 months post-implant - Lead-related Complication-Free Rate (CFR) from Implant through 3 months post-implant | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints; - All-cause mortality of the enrolled subject population - Hospitalization rate due to decompensated heart failure in the enrolled subject population - Lead related CFR from 3 months through 15 months post-implant - LV-lead pacing threshold and electrical lead performance in mid to basal pacing position - LV-lead pacing threshold and electrical lead performance for pre-specified / stipulated electrodes - All-cause operative system revision - Markers of LV remodelling: distal electrode sensing amplitude and Q-E1, Q-E2 delay - All alerts which occurred in devices connected with LATITUDE will be compared with reported adverse events - LATITUDE alerts and reported adverse events will be compared with recorded diagnostic data which are available at the same time | — |
Countries
Netherlands
Outcome results
None listed