N/A
Completed N=863
Maximizing CRT Delivery by Using MultipolAr Coronary Sinus Lead FamiLy ACUITY® X4 - RALLY X4 Study
Heartfailure
Source: ClinicalTrials.gov NCT02066467 ↗
Enrolled (actual)
863
Serious AEs
40.3%
Results posted
Sep 2019
Primary outcomePrimary: Phrenic Nerve Complication Free Rate — 99.5 % of participants — p=<0.0001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phrenic Nerve Complication Free Rate |
99.5 | <0.0001 sig |
| SECONDARY 3 Month Lead-related Complication-Free Rate (CFR) |
98.8 | — |
Eligibility Criteria
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:
- 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 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
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Data sourced from ClinicalTrials.gov (NCT02066467). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.