Global Paradise System US Post Approval Study

NCT06297291 | Recruiting FDA Device

• 1 other identifier: CLN 0984
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 38

Brief Summary

The objective of the Global Paradise® System US Post Approval Study (US GPS) is to evaluate the real-world use of the Paradise Ultrasound Renal Denervation System indicated for patients who are unable to lower their blood pressure with lifestyle changes and medication. This system is comprised of a catheter, cable, balloon, and generator and has received FDA approval in the United States. Information collected in this study will be analyzed to better understand the long-term safety and effectiveness of treatment with the Paradise System for patients with high blood pressure.

Conditions

Hypertension; Cardiovascular Diseases; Vascular Diseases

Keywords

Blood Pressure; Uncontrolled Hypertension; Essential Hypertension; Resistant Hypertension; Renal Denervation; Ultrasound Renal Denervation

Outcome Measures

Primary Outcomes (2)

• Co-Primary Endpoint #1: Group Mean BP reduction

  * Ho: Reduction in mean home systolic BP from baseline to 3 months \< 5 mmHg * Ha: Reduction in mean home systolic BP from baseline to 3 months ≥ 5 mmHg

  Baseline to 3-months post-procedure

• Co-Primary Endpoint #2: Subject Responder

  A subject will be defined as a responder if they achieve any of the following: * Control in home BP (defined as systolic BP \<130 mmHg) at 3 months and/or * Absolute reduction in home systolic BP fall ≥ 5 mmHg at 3 months and/or * Reduction in medication burden measured using defined daily dose (DDD)

  Baseline to 3-months post-procedure

Secondary Outcomes (9)

• Change in mean home systolic/diastolic BP in mmHg

  [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]

• Change in mean office systolic/diastolic BP in mmHg

  [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]

• Change in home and office pulse pressure

  [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]

• Change in the number and/or dosage and/or type of antihypertensive medications taken

  [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]

• Change in patient reported outcomes

  [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]

Study Arms (2)

Prospective Ultrasound Renal Denervation Treatment

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.

Device: Paradise Ultrasound Renal Denervation Treatment

RADIANCE CAP Transfer

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.

Interventions

Paradise Ultrasound Renal Denervation Treatment DEVICE

The Paradise Ultrasound Renal Denervation System (Paradise Ultrasound RDN) is an FDA-approved catheter-based system to treat hypertension by ablating the nerves around the renal arteries, disrupting the overactive sympathetic nerves that can cause high blood pressure. The Paradise procedure uses ultrasound energy to calm the nerves near the kidneys to help lower blood pressure. Treatment is usually done in an outpatient setting and typically takes about an hour to perform. As a part of the treatment, a small flexible tube (catheter) is guided into the blood vessels near the kidneys and 7 seconds of ultrasound energy is applied 2-3 times. Both sides are treated and then the catheter is removed, leaving nothing behind. After the procedure, some people go home the same day or some stay overnight.

Also known as: Paradise Ultrasound RDN

Prospective Ultrasound Renal Denervation Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hypertension patients in whom lifestyle modifications and antihypertensive medications do not adequately control BP will be identified from the general population by the enrolling center. Subjects enrolled in the RADIANCE CAP study will be transferred to the US GPS study after completion of their 12-month follow-up visit in the RADIANCE CAP study, to complete the remainder of the long-term annual follow-up visits under the post approval study protocol.

You may qualify if:

• Signed and dated study informed consent
• Documented history of hypertension
• Documented history of prior or current antihypertensive medication(s)
• Mean seated office systolic BP at screening ≥ 140 mmHg
• Mean pre-procedure home systolic BP of ≥ 135 mmHg
• Estimated glomerular filtration rate (eGFR) of ≥30 mL/min/m2

You may not qualify if:

• Patients who meet the following will be excluded from participation:
• Patient lacks appropriate renal anatomy for any treatment with the Paradise Catheter
• Patient under the age of 18 years old at the time of consent
• Patient is pregnant
• Patients with transplanted kidney
• Presence of abnormal kidney (or secreting adrenal) tumors
• To confirm eligibility for treatment with the Paradise System, the following contraindications listed in the IFU may be determined at the time of procedure prior to treatment:
• Renal arteries with diameter \< 3mm and \> 8mm
• Renal artery with fibromuscular dysplasia (FMD)
• Stented renal artery
• Renal artery aneurysm
• Renal artery diameter stenosis \>30%
• Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter

Sponsors & Collaborators

• ReCor Medical, Inc.: lead

Study Sites (38)

Sutter Institute for Medical Research

Sacramento, California, 95816, United States

RECRUITING

UC Davis Medical Center

Sacramento, California, 95817, United States

RECRUITING

Pacific Heart Institute

Santa Monica, California, 90404, United States

RECRUITING

Rocky Mountain Regional VAMC

Aurora, Colorado, 80045, United States

RECRUITING

Bridgeport Hosptial

Bridgeport, Connecticut, 06610, United States

RECRUITING

The Cardiac & Vascular Institute

Gainesville, Florida, 32605, United States

RECRUITING

University of Miami Health System

Miami, Florida, 33136, United States

RECRUITING

Ascension Sacred Heart

Pensacola, Florida, 32504, United States

RECRUITING

Tampa Cardiovascular Interventions and Research

Tampa, Florida, 33614, United States

RECRUITING

Southern Illinois University, Memorial Medical Center

Springfield, Illinois, 62702, United States

RECRUITING

Ascension via Christi St. Francis

Wichita, Kansas, 67214, United States

RECRUITING

Touro Infirmary

New Orleans, Louisiana, 70112, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

The Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Henry Ford Health

Detroit, Michigan, 48202, United States

RECRUITING

Metropolitan Heart & Vascular Institute

Coon Rapids, Minnesota, 55433, United States

RECRUITING

Saint Luke's Mid America Heart Institute

Kansas City, Missouri, 64111, United States

RECRUITING

Virtua Health

Marlton, New Jersey, 08053, United States

RECRUITING

Albany Medical Center

Albany, New York, 12208, United States

RECRUITING

NewYork-Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, 11215, United States

RECRUITING

University at Buffalo

Buffalo, New York, 14203, United States

RECRUITING

NYU Langone Health - Bellevue Hosptial

New York, New York, 10016, United States

RECRUITING

Columbia University Medical Center/New York Presbyterian Hospital

New York, New York, 10032, United States

RECRUITING

Stony Brook Medicine

Stony Brook, New York, 11794, United States

RECRUITING

University of North Carolina at Chapel Hill School of Medicine

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Durham VA Health System

Durham, North Carolina, 27705, United States

RECRUITING

UPMC Harrisburg

Harrisburg, Pennsylvania, 17110, United States

RECRUITING

Penn Medicine

Phildelphia, Pennsylvania, 19104, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Prisma Health Richland Hospital

Columbia, South Carolina, 29203, United States

RECRUITING

Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

RECRUITING

Ascension Saint Thomas

Nashville, Tennessee, 37205, United States

RECRUITING

Ascension Seton

Austin, Texas, 78705, United States

RECRUITING

Dallas VAMC

Dallas, Texas, 75216, United States

RECRUITING

TCR Institute

Kingwood, Texas, 77339, United States

RECRUITING

St. Mark's Hospital

Salt Lake City, Utah, 84124, United States

RECRUITING

Inova Fairfax Hospital

Fairfax, Virginia, 22042, United States

RECRUITING

Swedish Medical Center

Seattle, Washington, 98122, United States

RECRUITING

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases; Vascular Diseases; Essential Hypertension

Central Study Contacts

Helen Reeve-Stoffer, PhD

CONTACT

+1 650-912-9032; hreeve-stoffer@recormedical.com

Liz Sheehan

CONTACT

Liz.Sheehan@recormedical.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 7, 2024
• Study Start: June 28, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): July 1, 2031
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (38)