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Clinical Trials in the UK / NCT05198674
Active, not recruiting Not applicable

SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN

NCT05198674 · tracked via the Priya Life Science UK tracker
Sponsor
Medtronic Vascular
Phase
Not applicable
Started
2021-10-20
Last updated
2026-10-16

Condition(s) studied

HypertensionVascular DiseasesCardiovascular DiseasesChronic Kidney DiseasesDiabetes Mellitus

Investigational drug(s) / intervention(s)

Renal Denervation (Symplicity Spyral™)

Renal Denervation (Symplicity Spyral™): Device: Symplicity Spyral™ multi-electrode renal denervation system. After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Individual is diagnosed with hypertension and has a baseline office systolic blood pressure ≥140 mmHg 2. Individual has a baseline office diastolic blood pressure ≥ 90 mmHg 3. Individual has an average systolic baseline home blood pressure ≥135 mmHg Exclusion Criteria: 1. Individual lacks appropriate renal artery anatomy 2. Individual has undergone prior renal denervation 3. Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement 4. Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea 5. Individual has an estimated glomerular filtration rate (eGFR) of \<45 6. Individual has one or more episode(s) of orthostatic hypotension 7. Individual is pregnant, nursing or planning to become pregnant 8. Individual has primary pulmonary hypertension 9. Individual has documented type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus with glycosylated hemoglobin greater than 8.0%

Primary outcome measure(s)

  • The Primary endpoint of office Systolic Blood Pressure (SBP) change at 6 months. — 6 months
    The Primary endpoint of office Systolic Blood Pressure (SBP) change at 6 months will be assessed for all patients in the Main Study Cohort

Trial sites (97)

FacilityCityRegionStatus
University of Alabama at Birmingham (UAB) Hospital Birmingham Alabama
Banner Heart Hospital Mesa Arizona
Abrazo Arizona Heart Hospital/Biltmore Cardiology Phoenix Arizona
HonorHealth Research Institute Scottsdale Arizona
Arkansas Cardiology Little Rock Arkansas
Scripps Memorial Hospital La Jolla California
Stanford Hospital and Clinics Stanford California
University of Colorado Anschutz Medical Campus Aurora Colorado
Colorado Heart and Vascular PC Lakewood Colorado
Hartford Hospital Hartford Connecticut
MedStar Washington Hospital Center Washington D.C. District of Columbia
BayCare Health System Clearwater Florida
Clearwater Cardiovascular Consultants Clearwater Florida
Baptist Medical Center Jacksonville Florida
University of Miami Hosptial Miami Florida
AdventHealth Orlando Orlando Florida
Orlando Health Heart & Vascular Institute Orlando Florida
BayCare Medical Group Safety Harbor Florida
Tallahassee Memorial Healthcare, Inc Tallahassee Florida
Emory University Hospital Midtown Atlanta Georgia
Piedmont Heart Institute Atlanta Georgia
Wellstar Research Institute Marietta Georgia
University of Chicago Medicine Chicago Illinois
Loyola University Medical Center Maywood Illinois
Heart Care Centers of Illinois Palos Park Illinois
St. Vincents Hospital Indianapolis Indiana
Mercy Medical Center West Des Moines Iowa
The Johns Hopkins Hospital Baltimore Maryland
Saint Joseph Medical Center (Towson MD) Towson Maryland
Beth Israel Deaconess Medical Center Boston Massachusetts
University of Michigan Ann Arbor Michigan
Henry Ford Hospital Detroit Michigan
Henry Ford Saint John Hospital Detroit Michigan
Spectrum Health Hospitals Grand Rapids Michigan
Saint Joseph Mercy Oakland Pontiac Michigan
Henry Ford Providence Southfield Hospital Southfield Michigan
Metropolitan Heart and Vascular Institute (MHVI) Coon Rapids Minnesota
CentraCare Heart & Vascular Center Saint Cloud Minnesota
North Mississippi Medical Center Tupelo Mississippi
University of Nebraska Medical Center Omaha Nebraska

+ 57 more sites — see the full list on the official registry below.

More Medtronic Vascular trials in the UK

Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension Recruiting
Prevail Global Study Recruiting

Other trials for the same condition

Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension Recruiting
A Study of the ReCor Medical Paradise System in Clinical Hypertension Active, not recruiting
Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease Recruiting
The "Global Paradise System" Registry Recruiting
BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05198674 on ClinicalTrials.gov ↗ ← All trials in the UK