Maximizing CRT Delivery by Using Multipolar Coronary Sinus Lead Family ACUITY X4

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 350

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

- 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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints:<br /><br>- PNS-related Complication-Free Rate (CFR) through 6 months post-implant<br /><br>- Lead-related Complication-Free Rate (CFR) from Implant through 3 months<br /><br>post-implant</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints;<br /><br>- All-cause mortality of the enrolled subject population<br /><br>- Hospitalization rate due to decompensated heart failure in the enrolled<br /><br>subject population<br /><br>- Lead related CFR from 3 months through 15 months post-implant<br /><br>- LV-lead pacing threshold and electrical lead performance in mid to basal<br /><br>pacing position<br /><br>- LV-lead pacing threshold and electrical lead performance for pre-specified /<br /><br>stipulated electrodes<br /><br>- All-cause operative system revision<br /><br>- Markers of LV remodelling: distal electrode sensing amplitude and Q-E1, Q-E2<br /><br>delay<br /><br>- All alerts which occurred in devices connected with LATITUDE will be compared<br /><br>with reported adverse events<br /><br>- LATITUDE alerts and reported adverse events will be compared with recorded<br /><br>diagnostic data which are available at the same time</p><br>

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