Active — Not RecruitingNot Applicable

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

United States1,899 participantsStarted 2021-10-20

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

The Primary endpoint of office Systolic Blood Pressure (SBP) change at 6 months.

Timeframe: 6 months

Trial details

NCT IDNCT05198674

SponsorMedtronic Vascular

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-11-30

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