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The SPYRAL AFFIRM Global Clinical Study of Renal Denervation with the Symplicity Spyral Renal Denervation System in Subjects with Uncontrolled Hypertension (SPYRAL AFFIRM)

SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN

  • Clinical Trial Information

    Trial Contact: Hernandez-Pagan, Gloryvee; Cox, Caitlin L; Ngo, George M.; Soto, William

  • IRB No: W23.085.05.

    Protocol Abbrev: SPYRAL AFFIRM

    Principal Investigator: Farhan Javed Khawaja, MD

    Phase: Device: Non-significant Risk

    Age Group: Adult

    Secondary Protocol No: MDT20044RDN004

    Treatment: Renal Denervation Procedure

    Therapies Involved: Procedural

    ClinicalTrials.gov ID: NCT05198674

  • Objective

    To evaluate the long-term safety, efficacy, and durability of the Symplicity Spyral system in a population of a minimum of 750 and up to 1000 renal denervation-treated subjects with up to 36 months of follow-up, including several sub-populations. Subsequently, these data will be used to complement data from the SPYRAL PIVOTALSPYRAL HTN-OFF MED trial, SPYRAL HTN-ON MED trial, and the Global SYMPLICITY Registry.

  • Key Eligibility

    All subjects in the Main Cohort must meet all Inclusion and no Exclusion criteria prior to undergoing the RDN procedure, unless otherwise noted. For subjects in the Continuation Cohort, all Inclusion/Exclusion criteria will need to have been met at the time of their initial procedure in the SPYRAL PIVOTAL- SPYRAL-HTN OFF MED or SPYRAL HTN-ON MED study participation unless otherwise noted.