SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontro… (NCT05198674) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN
United States, Australia, Belgium1,899 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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing renal denervation — a procedure that uses a catheter to reduce nerve activity around the kidney arteries — for uncontrolled high blood pressure. Can you explain how this procedure works and whether my specific situation, including any kidney disease or diabetes I have, might make me a good or poor candidate for this kind of approach?
2The trial is listed as 'active, not recruiting,' which means they're no longer enrolling new patients. Does that mean this exact study is closed to me, and are there similar renal denervation studies or expanded access options I should look into instead?
3The main thing this study is measuring is how much systolic blood pressure drops after 6 months — but what happens after that? How would we know if the blood pressure reduction lasts long-term, and what does the current evidence say about durability of renal denervation results?
4Since this trial is listed as 'Phase NA,' which often applies to device studies rather than drug trials, can you help me understand what that means for how much safety and effectiveness data already exists for this specific Symplicity Spyral device?
5Given that my blood pressure is uncontrolled, would it make more sense to first try adjusting or adding to my current medications before considering a procedure like renal denervation, or is there a reason you'd want to explore this trial as a path forward?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Primary endpoint of office Systolic Blood Pressure (SBP) change at 6 months.