Global Paradise System US Post Approval Study (US GPS)

ReCor Medical

Status: Enrolling

Conditions: Hypertension; Cardiovascular Diseases; Vascular Diseases

Treatments: Device: Paradise Ultrasound Renal Denervation Treatment

Study type: Observational

Funder types: Industry

Identifiers

NCT06297291

CLN0984

Details and patient eligibility

About

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.

Full description

In some patients with high blood pressure, the nerves surrounding the blood vessels leading to the kidneys are overactive, which may cause blood pressure to increase. Renal denervation is a procedure where a catheter is placed inside these blood vessels and heat is used to ablate and disable the nerve activity and lower blood pressure.

Hypertension patients that meet the study eligibility criteria will undergo the ultrasound renal denervation procedure using the Paradise System and will be asked to measure their blood pressure throughout the study, including measuring BP out of the clinic setting using a home BP monitoring device provided by the study. Participants will also be asked to answer some questions about their quality of life, health, sleep and emotions. Additional demographic data, medical history and socio-economic data may also be collected. As part of study participation, everyone who receives ultrasound renal denervation will be seen by the study doctor and designated study team members for 60 months (5 years) following the procedure.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

RADIANCE CAP patients must provide signed and dated informed consent for inclusion in long-term follow-up. No other criteria are required for inclusion.

Exclusion criteria

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

Trial design

1,000 participants in 2 patient groups

Prospective Ultrasound Renal Denervation Treatment

Description:

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.

Treatment:

Device: Paradise Ultrasound Renal Denervation Treatment

RADIANCE CAP Transfer

Description:

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.