Spyral InSight: renal nerve stimulation before and after renal denervation

Spyral InSight Early Clinical Feasibility Study

This study will test whether stimulating the nerves of the kidney before and after renal denervation is safe and how it changes blood pressure in adults 20–70 with moderately uncontrolled hypertension on 1–3 medications.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 19 (estimated)
• Ages: 20 Years to 70 Years
• Sex: All
• Sponsor: Medtronic Vascular (industry)
• Locations: 2 sites (Athens and 1 other locations)
• Trial ID: NCT07013929 on ClinicalTrials.gov

What this trial studies

This is an early, exploratory clinical assessment that uses renal nerve stimulation (RNS) performed both before and after renal artery denervation (RDN) with the Symplicity Spyral system to characterize physiological responses and monitor safety. There is no single pre-specified primary endpoint; the focus is procedural and longer-term safety and quantifying acute and post-procedural blood pressure and sympathetic responses. Participants are followed at 1, 3, 6 and 12 months after the procedure to record safety events and physiological measures. The study enrolls adults with office and 24-hour blood pressure in the specified hypertensive ranges who are taking one to three antihypertensive drug classes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 20–70 with office systolic BP 150–179 mmHg (diastolic ≥90 mmHg), a 24-hour ABPM average SBP 135–169 mmHg, and who are taking one to three antihypertensive medication classes without prior renal denervation and with acceptable renal artery anatomy and eGFR ≥60.

Not a fit: Patients with prior renal denervation, unsuitable renal artery anatomy or stents, eGFR <60, use of SGLT2 inhibitors or GLP-1 agonists, secondary causes of hypertension, pregnancy, or other conditions that prevent accurate blood pressure measurement are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this work could help clinicians better understand kidney nerve responses and improve the safety and targeting of renal denervation for blood pressure control.

How similar studies have performed: Previous renal denervation trials have shown mixed results for blood pressure lowering, and using renal nerve stimulation to characterize physiological response before and after RDN is a relatively novel, early-stage approach with limited prior human data.

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.

Where this trial is running

Athens and 1 other locations

• Hippokration General Hospital of Athens — Athens, Greece (RECRUITING)
• University Hospital Galway — Galway, Ireland (RECRUITING)

Study contacts

• Study coordinator: Sjors Wijnands

Conditions: Hypertension, Vascular Diseases, Cardiovascular Diseases, Denervation, Renal Denervation