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

Clinical Trial Information

Trial Contact: Ngo, George M., Soto, William, Velez, Vanessa

IRB No: W23.085.05.

Principal Investigator: Khawaja, Farhan J., MD

Phase: N/A

Age Group: ADULTOLDER_ADULT

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.

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