Global Paradise System US Post Approval Study

Hypertension Clinical Trial

— US GPS  

Official title:

The Global Paradise® System US Post Approval Study (US GPS)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06297291
• Other study ID #: CLN0984
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: July 2031

Study information

• Verified date: February 2024
• Source: ReCor Medical, Inc.
• Contact: Helen Reeve-Stoffer, PhD
• Phone: +1 650-912-9032
• Email: hreeve-stoffer[@]recormedical.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: July 2031
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypertension
• Vascular Diseases

Intervention

Device:
• Paradise Ultrasound Renal Denervation Treatment
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ReCor Medical, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in mean home systolic/diastolic BP in mmHg		[baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]
Secondary	Change in mean office systolic/diastolic BP in mmHg		[baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]
Secondary	Change in home and office pulse pressure		[baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]
Secondary	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]
Secondary	Change in patient reported outcomes		[baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]
Secondary	Percentage of patients who are controlled as measured by various cut points of home BP (control to be assessed as both < 130 mmHg systolic and <135 mmHg systolic) office BP (control to also be assessed as <130 mmHg and <140 mmHg systolic)		[baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]
Secondary	Percentage of patients who demonstrate a reduction in home systolic BP of = 5mmHg, = 10 mmHg and = 15 mmHg		[at 3, 6, 12, 24, 36, 48 and 60 months compared to baseline]
Secondary	Percentage of patients who demonstrate a reduction in office systolic BP of = 5mmHg, = 10 mmHg and = 15 mmHg		[at 3, 6, 12, 24, 36, 48 and 60 months compared to baseline]
Secondary	Change in home and office heart rate		[at 3, 6, 12, 24, 36, 48 and 60 months compared to baseline]