Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN
NCT05198674 · View on ClinicalTrials.gov ↗
Study Summary
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 Studied
Interventions
- DEVICE Renal Denervation (Symplicity Spyral™)
Study Locations (20)
Florida
- BayCare Health System — Clearwater
- Clearwater Cardiovascular Consultants — Clearwater
- Baptist Medical Center — Jacksonville
- University of Miami Hosptial — Miami
- AdventHealth Orlando — Orlando
- Orlando Health Heart & Vascular Institute — Orlando
- BayCare Medical Group — Safety Harbor
- Tallahassee Memorial Healthcare, Inc — Tallahassee
Arizona
- Banner Heart Hospital — Mesa
- Abrazo Arizona Heart Hospital/Biltmore Cardiology — Phoenix
- HonorHealth Research Institute — Scottsdale
California
- Scripps Memorial Hospital — La Jolla
- University of California, San Francisco — San Francisco
- Stanford Hospital and Clinics — Stanford
Colorado
- University of Colorado Anschutz Medical Campus — Aurora
- Colorado Heart and Vascular PC — Lakewood
Alabama
- University of Alabama at Birmingham (UAB) Hospital — Birmingham
Arkansas
- Arkansas Cardiology — Little Rock
Connecticut
- Hartford Hospital — Hartford
District of Columbia
- MedStar Washington Hospital Center — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,300 participants |
| Start Date | 2021-10-20 |
| Est. Completion | 2029-11-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05198674
The ClinicalTrials.gov registry entry for NCT05198674 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Vascular, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Hypertension appearing as the primary indexed condition, and to 1 intervention — of which Renal Denervation (Symplicity Spyral™) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05198674 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Florida, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05198674 about?
NCT05198674 is a clinical study titled "SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN". 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 th...
What is the current status of trial NCT05198674?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 1,300 participants. The study started on 2021-10-20. Estimated completion is 2029-11-30.
What conditions does trial NCT05198674 study?
This clinical trial studies the following conditions: Hypertension, Cardiovascular Diseases, Diabetes Mellitus, Chronic Kidney Diseases, Vascular Diseases. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05198674?
The interventions under investigation include: Renal Denervation (Symplicity Spyral™) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05198674?
This trial is sponsored by Medtronic Vascular, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05198674 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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