No phaseActive, not recruiting
SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN
The SPYRAL AFFIRM Global Clinical Study of Renal Denervation With the Symplicity Spyral Renal Denervation System in Subjects With Uncontrolled Hypertension (SPYRAL AFFIRM)
- Sponsor
- Medtronic Vascular (Industry)
- Enrollment
- 1,899 enrolled
- Conditions
- Hypertension; Vascular Diseases; Cardiovascular Diseases; Chronic Kidney Diseases; Diabetes Mellitus
- Interventions
- Renal Denervation (Symplicity Spyral™)
- Ages
- adults, older adults
- Registry
- NCT05198674
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- The Primary endpoint of office Systolic Blood Pressure (SBP) change at 6 months.
History
Study completion expected
Last registry update
Primary completion
Registered
Started
Papers citing this trial
- Effectiveness of Radiofrequency Renal Denervation in the United States: Six-Month Primary End Point Results From the SPYRAL AFFIRM Study
Circulation. Cardiovascular interventions