Gemini System for High Blood Pressure

(SPYRAL GEMINI Trial)

Recruiting at 3 trial locations

Overseen By Cecile Mahoney

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Vascular

Disqualifiers: Diabetes, Stroke, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

175 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

The SPYRAL GEMINI Pilot Study is for adults with uncontrolled high blood pressure (office SBP ≥150 mmHg and <180 mmHg, DBP ≥90 mmHg, and a 24-hour average SBP of ≥140 mmHg but <170 mmHg). It's especially for those at high cardiovascular risk due to conditions like chronic kidney disease or diabetes.

Inclusion Criteria

24-hour average SBP ≥140 mmHg and <170 mmHg measured by ABPM at Baseline

I am between 18 and 80 years old.

I have high blood pressure with specific readings.

Exclusion Criteria

Documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement

Estimated glomerular filtration rate (eGFR) of <40

Pregnant, nursing or planning to become pregnant during the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo multi-organ denervation with the Gemini System

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

Treatment Details

Interventions

• Gemini System

Trial Overview This study tests the Gemini System's ability to safely perform multi-organ denervation. The goal is to see if it can lower blood pressure in people with hypertension who are not adequately controlled by their current treatment.

Participant Groups

Group I: Gemini Pilot On Med: MDN for Hypertension and High Cardiovascular Risk On Anti-hypertensive Meds. Experimental Treatment 1 Intervention

Group II: Gemini Pilot Off Med: Multi-Organ Denervation for Hypertension Off Anti-hypertensive Meds Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Medtronic Vascular

Lead Sponsor

Trials

67

Recruited

57,500+

Geoff Martha

Medtronic Vascular

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Laura Mauri

Medtronic Vascular

Chief Medical Officer since 2022

MD from Harvard Medical School