Status:
ACTIVE_NOT_RECRUITING
SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN
Lead Sponsor:
Medtronic Vascular
Conditions:
Hypertension
Vascular Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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. Additiona...
Eligibility Criteria
Inclusion
- Individual is diagnosed with hypertension and has a baseline office systolic blood pressure ≥140 mmHg
- Individual has a baseline office diastolic blood pressure ≥ 90 mmHg
- Individual has an average systolic baseline home blood pressure ≥135 mmHg
Exclusion
- Individual lacks appropriate renal artery anatomy
- Individual has undergone prior renal denervation
- Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement
- Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
- Individual has an estimated glomerular filtration rate (eGFR) of \<45
- Individual has one or more episode(s) of orthostatic hypotension
- Individual is pregnant, nursing or planning to become pregnant
- Individual has primary pulmonary hypertension
- Individual has documented type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus with glycosylated hemoglobin greater than 8.0%
Key Trial Info
Start Date :
October 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2029
Estimated Enrollment :
1300 Patients enrolled
Trial Details
Trial ID
NCT05198674
Start Date
October 20 2021
End Date
November 30 2029
Last Update
October 20 2025
Active Locations (100)
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1
University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama, United States, 35233
2
Banner Heart Hospital
Mesa, Arizona, United States, 85206
3
Abrazo Arizona Heart Hospital/Biltmore Cardiology
Phoenix, Arizona, United States, 85016
4
HonorHealth Research Institute
Scottsdale, Arizona, United States, 85258