| NCT ID | NCT07013929 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medtronic Vascular |
| Condition | Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 19 participants |
| Start Date | 2025-06-09 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 19 participants in total. It began in 2025-06-09 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the Spyral InSight Early Clinical Feasibility Study is to characterize the physiological response to renal nerve stimulation (RNS) in humans prior to and post renal denervation.
Eligibility Criteria
Inclusion Criteria: 1. 20 - 70 years of age 2. Office SBP ≥150 mmHg and \<180 mmHg and DBP ≥90 mmHg 3. Individual is prescribed with one, two, or three antihypertensive medication classes 4. 24-hour ABPM average of SBP ≥135 and \<170 mmHg at Baseline Exclusion Criteria: 1. Prior renal denervation. 2. Individual lacks appropriate renal artery Anatomy 3. Has a renal artery stent 4. Individual has an estimated glomerular filtration rate (eGFR) of \<60 mL/min/1.73m2 5. Individual is taking SGLT2 inhibitors or GLP-1 agonists 6. Individual requires chronic oxygen support or mechanical ventilation 7. Primary pulmonary hypertension. 8. Secondary cause of hypertension 9. Pregnant, nursing or planning to become pregnant during the study. 10. Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement 11. Individual is currently taking anti-mineralocorticoid drugs.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07013929 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 70 Years, studying Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07013929 currently recruiting?
Yes, NCT07013929 is actively recruiting participants. Contact the research team at sjors.wijnands@medtronic.com for enrollment information.
Where is the NCT07013929 trial being conducted?
This trial is being conducted at Athens, Greece, Galway, Ireland.
Who is sponsoring the NCT07013929 clinical trial?
NCT07013929 is sponsored by Medtronic Vascular. The trial plans to enroll 19 participants.