ClinicaliQ Trial Snapshot
- SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN — Active Not Recruiting • Non-phase study • Diabetes / Metabolic • NCT05198674.
- SPYRAL AFFIRM: One-sentence summary.
- Renal denervation using Symplicity Spyral safely and effectively lowers blood pressure in patients with uncontrolled hypertension.
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What This Trial Is Studying
The purpose of this single-arm interventional study is to evaluate the long-term safety, efficacy, and durability of the Symplicity Spyral system in subjects treated with renal denervation. Additionally, long-term follow-up data will also be collected from eligible subjects previously treated in the SPYRAL PIVOTAL-SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED studies. Conditions: Hypertension, Vascular Diseases, Cardiovascular Diseases, Chronic Kidney Diseases, Diabetes Mellitus Interventions: Renal Denervation (Symplicity Spyral™) Lead Sponsor: Medtronic Vascular Planned Enrollment: 1899 participants