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Clinical trial

Maximizing CRT Delivery by Using MultipolAr Coronary Sinus Lead FamiLy ACUITY� X4 - RALLY X4 Study (RallyX4)

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Last updated:7th Feb 2014

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.

Category Value
Study start date 2014-02-07

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