Clinical trial NCT06297291: Global Paradise System US Post Approval Study
Official title: The Global Paradise® System US Post Approval Study (US GPS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypertension
Cardiovascular Diseases
Vascular Diseases
Keywords: Blood Pressure
Uncontrolled Hypertension
Essential Hypertension
Resistant Hypertension
Renal Denervation
Ultrasound Renal Denervation
Lead sponsor: ReCor Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2024-03-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

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

Primary outcomes:
measure: Co-Primary Endpoint #1: Group Mean BP reduction
timeFrame: Baseline to 3-months post-procedure
measure: Co-Primary Endpoint #2: Subject Responder
timeFrame: Baseline to 3-months post-procedure
Secondary outcomes:
measure: Change in mean home systolic/diastolic BP in mmHg
timeFrame: [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]
measure: Change in mean office systolic/diastolic BP in mmHg
timeFrame: [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]
measure: Change in home and office pulse pressure
timeFrame: [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]
measure: Change in the number and/or dosage and/or type of antihypertensive medications taken
timeFrame: [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]
measure: Change in patient reported outcomes
timeFrame: [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]
measure: 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)
timeFrame: [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]
measure: Percentage of patients who demonstrate a reduction in home systolic BP of ≥ 5mmHg, ≥ 10 mmHg and ≥ 15 mmHg
timeFrame: [at 3, 6, 12, 24, 36, 48 and 60 months compared to baseline]
measure: Percentage of patients who demonstrate a reduction in office systolic BP of ≥ 5mmHg, ≥ 10 mmHg and ≥ 15 mmHg
timeFrame: [at 3, 6, 12, 24, 36, 48 and 60 months compared to baseline]
measure: Change in home and office heart rate
timeFrame: [at 3, 6, 12, 24, 36, 48 and 60 months compared to baseline]
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Sutter Institute for Medical Research
state: California
city: Aurora
country: United States
facility: Rocky Mountain Regional VAMC
state: Colorado
city: Bridgeport
country: United States
facility: Bridgeport Hosptial
state: Connecticut
city: Gainesville
country: United States
facility: The Cardiac & Vascular Institute
state: Florida
city: Miami
country: United States
facility: University of Miami Health System
state: Florida
city: Pensacola
country: United States
facility: Ascension Sacred Heart
state: Florida
city: Springfield
country: United States
facility: Southern Illinois University, Memorial Medical Center
state: Illinois
city: New Orleans
country: United States
facility: Touro Infirmary
state: Louisiana
city: Boston
country: United States
facility: The Brigham and Women's Hospital
state: Massachusetts
city: Kansas City
country: United States
facility: Saint Luke's Mid America Heart Institute
state: Missouri
city: Marlton
country: United States
facility: Virtua Health
state: New Jersey
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
city: New York City
country: United States
facility: NYU Langone Health - Bellevue Hosptial
state: New York
city: New York City
country: United States
facility: Columbia University Medical Center/New York Presbyterian Hospital
state: New York
city: Stony Brook
country: United States
facility: Stony Brook Medicine
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill School of Medicine
state: North Carolina
city: Durham
country: United States
facility: Durham VA Health System
state: North Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Columbia
country: United States
facility: Prisma Health Richland Hospital
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Regional Medical Center
state: South Carolina
city: Nashville
country: United States
facility: Ascension Saint Thomas
state: Tennessee
city: Austin
country: United States
facility: Ascension Seton
state: Texas
city: Kingwood
country: United States
facility: TCR Institute
state: Texas
city: Fairfax
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
References: