Renal Denervation for High Blood Pressure

(RADIANCE CAP Trial)

Recruiting at 39 trial locations

Overseen By Konstantinos Charitakis, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: ReCor Medical, Inc.

Must be taking: Antihypertensives

Disqualifiers: Type I diabetes, Uncontrolled Type II diabetes, Severe cardiovascular event, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a treatment that uses ultrasound waves to target kidney nerves to help lower blood pressure. It is aimed at patients whose high blood pressure does not improve with standard medications. The goal is to see if this method is safe and effective for these patients.

Who Is on the Research Team?

Ajay Kirtane, MD

Principal Investigator

Columbia University Medical Center/NYPH

Naomi Fisher, MD

Principal Investigator

Brigham and Women's Hospital/Harvard Medical School

Are You a Good Fit for This Trial?

This trial is for individuals with high blood pressure that remains uncontrolled despite taking medication. Participants must have a documented average office blood pressure of at least 140/90 mmHg and daytime ambulatory blood pressure of at least 135/85 mmHg. They should not have had severe cardiovascular events or strokes in the past three months, be pregnant, or have certain conditions like Type I diabetes or severely impaired kidney function.

Inclusion Criteria

My blood pressure is 140/90 or higher, even though I've been on blood pressure medicine for over 4 weeks.

My daytime blood pressure is 135/85 mmHg or higher, even after 4 weeks on blood pressure medication.

Exclusion Criteria

Pregnant, nursing or planning to become pregnant

My kidney's blood vessels are not suitable for treatment.

I haven't had a stroke or major heart issue in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ultrasound renal denervation therapy via the Paradise System

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Paradise System

Trial Overview The RADIANCE CAP study is testing ultrasound renal denervation therapy using the Paradise System to treat uncontrolled hypertension. It's an ongoing non-randomized trial providing access to this treatment while collecting data on its safety and effectiveness.

How Is the Trial Designed?

Group I: Renal Denervation Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

ReCor Medical, Inc.

Lead Sponsor

Trials

11

Recruited

5,200+