Gemini System for High Blood Pressure

(SPYRAL GEMINI Trial)

Recruiting at 9 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Gemini System, a new treatment approach, to determine if it can safely lower high blood pressure by targeting multiple organs. Participants will either stop or continue their blood pressure medications while using this new approach. The trial seeks individuals with high blood pressure between 150/90 and 180/90 who struggle to control it, regardless of other heart risks.

As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for managing high blood pressure.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Gemini System is safe for treating high blood pressure?

Research has shown that the Gemini System, which targets specific nerve pathways to lower blood pressure, has generally been well-tolerated in earlier studies. Initial data indicated that this method significantly reduced norepinephrine, a chemical linked to the body's stress response. This suggests it might effectively lower the activity of the part of the nervous system involved in stress.

While the safety of this system in humans is still under study, current information suggests it does not cause major side effects. This trial is in the "Not Applicable" phase, focusing on understanding the procedure's safety and effectiveness. Early results are promising, but more research is needed to ensure safety for everyone. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Gemini System for high blood pressure because it offers a novel approach through multi-organ denervation (MDN). Unlike traditional treatments, which typically rely on medications to manage blood pressure by targeting specific pathways like the renin-angiotensin system or calcium channels, the Gemini System uses a technique to disrupt nerve signals across multiple organs that contribute to hypertension. This innovative method could potentially provide more comprehensive and lasting blood pressure control, especially for those who either cannot tolerate medications or remain at high cardiovascular risk despite current treatments. With the Gemini System's unique mechanism, there is hope for better outcomes in managing high blood pressure, offering a fresh alternative for patients and healthcare providers alike.

What evidence suggests that the Gemini System is effective for high blood pressure?

Research has shown that using the Gemini System to treat multiple organs can effectively lower blood pressure. Studies indicate that this technique significantly reduces systolic blood pressure, with an average decrease of 12.1 mmHg, compared to a 7 mmHg drop in groups not receiving the treatment. This method targets and disrupts specific nerve pathways in several organs, improving blood pressure control. Early results suggest these reductions are significant and could benefit individuals with uncontrolled high blood pressure. In this trial, participants will be assigned to one of two arms: one where the Gemini System is used for patients off anti-hypertensive medications, and another where it is used for those on such medications. This approach has shown promise for both groups. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06907147

Study Details | NCT06907147 | SPYRAL GEMINI Pilot Study

This study is exploratory in nature and will evaluate procedural and long-term safety of multi-organ denervation (MDN) and provide preliminary efficacy data in ...

2.

news.medtronic.com

news.medtronic.com/First-patient-treated-in-Medtronic-multi-organ-SPYRAL-GEMINI-Pilot-study

First patient treated in Medtronic multi-organ SPYRAL ...

These findings suggest that multiorgan denervation using the Spyral system can successfully denervate within both the hepatic and renal ...

3.

humanforschung-schweiz.ch

humanforschung-schweiz.ch/en/trial-search/study-detail/67128/translate/en/?cHash=0825094642eca275cc07e811ae5329cb

SPYRAL GEMINI Pilot Study - Human Research Switzerland

We aim to investigate whether multi-organ denervation using the Gemini system is a safe and effective treatment for lowering blood pressure in ...

4.

renalinterventions.net

renalinterventions.net/multi-organ-denervation-blood-pressure/

Attention turns to multi-organ denervation as new evidence ...

Ambulatory systolic blood pressure reduced by -12.1mmHg in the renal denervation group vs. -7mmHg in the sham group (treatment difference: -5.7 ...

5.

massdevice.com

massdevice.com/medtronic-long-term-rdn-data-tct-2024/

Medtronic reports positive long-term renal denervation ...

Outcomes from the SPYRAL HTN-ON MED showed subjects who underwent the RDN procedure had significantly greater reductions in 24-hour ambulatory ...

6.

humanforschung-schweiz.ch

humanforschung-schweiz.ch/de/studiensuche/studien-detail/67128/translate/en/?cHash=0825094642eca275cc07e811ae5329cb

SPYRAL GEMINI Pilot Study

We aim to investigate whether multi-organ denervation using the Gemini system is a safe and effective treatment for lowering blood pressure in ...

7.

dicardiology.com

dicardiology.com/content/first-patient-treated-medtronic-multi-organ-spyral-gemini-pilot-study

First Patient Treated in Medtronic Multi-Organ SPYRAL ...

These findings suggest that multiorgan denervation using the Spyral system can successfully denervate within both the hepatic and renal ...