Paradise Ultrasound Renal Denervation for High Blood Pressure

(US GPS Trial)

Recruiting at 33 trial locations

Overseen By Liz Sheehan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: ReCor Medical, Inc.

Must be taking: Antihypertensives

Disqualifiers: Pregnancy, Kidney transplant, Abnormal tumors, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of the Paradise Ultrasound Renal Denervation System for individuals with high blood pressure unresponsive to lifestyle changes and medications. The system uses an advanced tool to target kidney nerves, aiming to lower blood pressure. Participants will contribute to understanding the long-term safety and effectiveness of this treatment. Ideal candidates have high blood pressure that remains uncontrolled with current treatments and a history of using blood pressure medications. As a Phase 3 trial, this represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications for this trial?

The trial information does not specify if you need to stop your current medications. It seems that the trial is for patients who have not been able to lower their blood pressure with medications, so you might continue your current treatment. However, it's best to confirm with the trial coordinators.

What is the safety track record for the Paradise Ultrasound Renal Denervation System?

Research has shown that the Paradise Ultrasound Renal Denervation System is generally safe for treating high blood pressure. In earlier studies, patients tolerated this system well. The procedure uses ultrasound energy to target overactive nerves in the kidneys, which can help lower blood pressure.

The FDA has already approved the device, indicating it has been tested in various studies and found to be safe. These studies did not report any major side effects, suggesting that most patients did not experience significant problems. However, like any medical procedure, some risks may exist, so discussing these with a doctor is important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the Paradise Ultrasound Renal Denervation treatment for hypertension because it offers a non-drug alternative by using focused ultrasound energy to target overactive nerves in the renal arteries. Unlike traditional medications that manage blood pressure by altering the function of the heart or blood vessels, this treatment works by disrupting the nerve pathways that contribute to high blood pressure. This innovative approach has the potential to provide long-lasting blood pressure reduction with a single procedure, reducing the need for daily medication and its associated side effects.

What evidence suggests that the Paradise Ultrasound Renal Denervation System is effective for high blood pressure?

This trial will evaluate the Paradise Ultrasound Renal Denervation System for its effectiveness in lowering high blood pressure. Research has shown that this system can effectively reduce blood pressure, with one study reporting an average drop of 19.6 mmHg six months after treatment. Several clinical trials, such as the RADIANCE study, have demonstrated significant blood pressure reduction in people with hypertension using this system. The system uses ultrasound energy to treat nerves in the kidneys, helping to control blood pressure. This treatment has proven safe and effective, offering hope for those who haven't succeeded with lifestyle changes or medication alone. Participants in this trial will be enrolled and monitored for 5 years post-procedure. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

Inclusion Criteria

I have signed and dated the consent form for this study.

I have a documented history of high blood pressure.

I have taken medication for high blood pressure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the ultrasound renal denervation procedure using the Paradise System

1 day

1 visit (in-person)

Initial Follow-up

Participants' blood pressure is monitored, and they are assessed for responder status at 3 months

3 months

1 visit (in-person), home BP monitoring

Long-term Follow-up

Participants are monitored for long-term safety and effectiveness of the treatment

60 months

Annual visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Paradise Ultrasound Renal Denervation Treatment

How Is the Trial Designed?

Group I: RADIANCE CAP Transfer Experimental Treatment 0 Interventions

Subjects enrolled in the RADIANCE Continued Access Protocol (CAP) study that are still active and have already completed their post-procedure 12-month follow-up visit are invited to participate in US GPS for long-term annual follow-up visits. These subjects will have already received the ultrasound Renal Denervation treatment under the RADIANCE CAP protocol and will not receive the procedure under the US GPS protocol.

Group II: Prospective Ultrasound Renal Denervation Treatment Experimental Treatment 1 Intervention

Hypertension patients that meet the eligibility criteria for treatment with Recor Medical Paradise Ultrasound Renal Denervation System will be enrolled and followed post-procedure for 5 years.

Who Is Running the Clinical Trial?

ReCor Medical, Inc.

Lead Sponsor

Trials

11

Recruited

5,200+

Citations

1. recormedical.com recormedical.com/latest-real-world-clinical-data-demonstrate-a-19-6-mmhg-reduction-in-blood-pressure-at-6-months-with-recor-medicals-paradise-ultrasound-renal-denervation-system/

Latest Real-World Clinical Data Demonstrate a 19.6 mmHg ... Latest Real-World Clinical Data Demonstrate a 19.6 mmHg Reduction in Blood Pressure at 6 Months with Recor Medical's Paradise Ultrasound Renal ...

2. recormedical.com recormedical.com/clinical-results-highlights/

Clinical Results Highlights Paradise Ultrasound Renal Denervation (uRDN) has been tested and proven effective across multiple clinical trials, including Recor's RADIANCE™ global ...

3. recormedical.com recormedical.com/paradise-ultrasound-rdn-system/

Paradise Ultrasound RDN System The Paradise® Ultrasound Renal Denervation System offers a high standard of therapy using power of ultrasound energy to treat hypertension.

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/P220023B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The Paradise Ultrasound Renal Denervation System (Paradise System) is indicated to reduce blood pressure as an adjunctive treatment in hypertension patients in ...

5. recormedical.com recormedical.com/publications/

Publications Safety and Efficacy of Endovascular Ultrasound Renal Denervation in Resistant Hypertension: 12-month Results From the ACHIEVE Study. J Hypertens. 2019;37(9): ...

6. recormedical.com recormedical.com/cms-issues-national-coverage-determination-for-recor-medicals-paradise-ultrasound-renal-denervation-system-for-the-treatment-of-hypertension/

CMS Issues National Coverage Determination for ... The Paradise uRDN system is currently commercially available for patients in the US, having received FDA approval in November 2023. The Paradise ...