Spyral InSight: renal nerve stimulation before and after renal denervation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hippokration General Hospital of Athens
  Athens, Greece Recruiting
• University Hospital Galway
  Galway, Ireland Recruiting

Study contacts

• Study coordinator: Sjors Wijnands
• Email: sjors.wijnands@medtronic.com
• Phone: +31 6 1113 5502

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.