Global Paradise System US Post Approval Study

Official title

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

Overview

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.

Detailed 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.

Interventions

• 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 trea

Primary outcome measures

• Co-Primary Endpoint #1: Group Mean BP reduction [Time frame: Baseline to 3-months post-procedure]
• Co-Primary Endpoint #2: Subject Responder [Time frame: Baseline to 3-months post-procedure]

Secondary outcome measures (9)

• Change in mean home systolic/diastolic BP in mmHg [Time frame: [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]]
• Change in mean office systolic/diastolic BP in mmHg [Time frame: [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]]
• Change in home and office pulse pressure [Time frame: [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 [Time frame: [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]]
• Change in patient reported outcomes [Time frame: [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]]
• 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) [Time frame: [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]]
• Percentage of patients who demonstrate a reduction in home systolic BP of ≥ 5mmHg, ≥ 10 mmHg and ≥ 15 mmHg [Time frame: [at 3, 6, 12, 24, 36, 48 and 60 months compared to baseline]]
• Percentage of patients who demonstrate a reduction in office systolic BP of ≥ 5mmHg, ≥ 10 mmHg and ≥ 15 mmHg [Time frame: [at 3, 6, 12, 24, 36, 48 and 60 months compared to baseline]]
• Change in home and office heart rate [Time frame: [at 3, 6, 12, 24, 36, 48 and 60 months compared to baseline]]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

United States · 39 centers

• Sutter Institute for Medical Research — Sacramento
• UC Davis Medical Center — Sacramento
• Pacific Heart Institute — Santa Monica
• Rocky Mountain Regional VAMC — Aurora
• Bridgeport Hosptial — Bridgeport
• The Cardiac & Vascular Institute — Gainesville
• University of Miami Health System — Miami
• Ascension Sacred Heart — Pensacola
• … and 31 more centers

Identifiers

NCT: NCT06297291 · CLN 0984

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗