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
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Clinical Trial Information
Trial Contact: Cox, Caitlin L; Ngo, George M.; Soto, William
Trial Phone: 321-841-1505 ; 3218439657 ; 321-843-1179
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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
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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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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.
