Tests a device for uncontrolled high blood pressure in adults
Tests whether a multi-organ nerve procedure is safe and lowers blood pressure in adults.
Plain-language title generated from the registry record
Registry title: SPYRAL GEMINI Pilot Study
Key facts
- Where
- Erlangen and Homburg, GermanySee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06907147, who can take part
Where in Germany
- University Hospital ErlangenErlangen, GermanyTaking people
- Universität Des SaarlandesHomburg, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medtronic Vascular
- Trial code
- NCT06907147
- Record updated
- 20 October 2026
- Original description
The purpose of the SPYRAL GEMINI Pilot Study is to evaluate that multi-organ denervation with the Gemini System is safe and provide evidence of blood pressure reduction when studied in an uncontrolled hypertensive population with and without high cardiovascular risk.Read full original descriptionShow less
Global Pilot Study of rEnal and Hepatic coMbINed denervatIon in Subjects With Uncontrolled Hypertension With and Without High Cardiovascular Risk
The purpose of the SPYRAL GEMINI Pilot Study is to evaluate that multi-organ denervation with the Gemini System is safe and provide evidence of blood pressure reduction when studied in an uncontrolled hypertensive population with and without high cardiovascular risk.
Inclusion: All Subjects (both cohorts):; ≥18 and ≤80 years of age; Diagnosed with HTN and has a baseline office SBP ≥150 mmHg and <180 mmHg and an office DBP ≥ 90 mmHg; 24-hour average SBP ≥140 mmHg and <170 mmHg measured by ABPM at Baseline.
Exclusion: Prior renal or hepatic denervation; History of NYHA Class III or IV heart failure within 6 months of screening visit; Stroke or transient ischemic attack (TIA) within 6 months of screening visit or any history of stroke leading to permanent disability; Documented Type 1 diabetes or use of insulin within 6 months; Secondary cause of hypertension; Documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement; Primary pulmonary arterial hypertension; History or evidence of active / suspected chronic liver or biliary disease; Estimated glomerular filtration rate (eGFR) of <40; Individual lacks appropriate renal artery OR common hepatic artery anatomy; Pregnant, nursing or planning to become pregnant during the study; Current or chronic pancreatitis.