NCT06297291ClinicalTrials.gov

Global Paradise System US Post Approval Study

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

RecruitingTaking participants now, according to the registry record.

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In brief

Observational1,000 participants sought43 sites1 country

Registered in 1 registry

ClinicalTrials.govNCT06297291Open this record at ClinicalTrials.govSynced last month

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Trial information is shown as published by the registry, in its original language.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2024-03-07; recorded start 2024-06-28
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Not stated: Whether participants are randomly assigned is not stated in the registry recordNo allocation method is recorded
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Not stated: Whether the study is blinded is not stated in the registry recordNo masking information is recorded
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 5 other studies in this databaseCounted from the lead sponsor named in the record (ReCor Medical, Inc.)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 3 conditions.
Lead sponsor type recorded as: industry.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourEXPLORATORY

An exploratory-stage design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation0/20
Allocation not stated in the record
Blinding0/20
Masking not stated in the record
Control arm0/15
No comparator arm stated in the record
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 39 sites
Data monitoring committee0/7
No data monitoring committee stated
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleLARGE

A large study: 1,000 participants (target), run at 43 sites.

How this score is built

Enrolment30/40
1,000 participants (target)
Site count19/25
39 sites
Country count0/15
Single country
Planned duration10/10
Planned over about 85 months
Sponsor scale2/10
ReCor Medical, Inc. has led 6 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

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.

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.

Conditions

Hypertension
Cardiovascular Diseases
Vascular Diseases

Eligibility

Eligibility
Sex	All
Ages	18 Years – No maximum
Healthy volunteers	No
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.

Eligibility as written in the registry

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

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study design
Study type	Observational
Phase	Not stated in the registry record
Allocation	Not stated in the registry record
Intervention model	Not stated in the registry record
Primary purpose	Not stated in the registry record
Masking	Not stated in the registry record
Enrolment	1,000 participants sought

Sponsor and collaborators

ReCor Medical, Inc. Sponsor

Arms and interventions

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.
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

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.

Outcome measures

Primary outcome
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
Time frame Baseline to 3-months post-procedure
Primary outcome
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)
Time frame Baseline to 3-months post-procedure
Secondary outcome
Change in mean home systolic/diastolic BP in mmHg
Time frame [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]
Secondary outcome
Change in mean office systolic/diastolic BP in mmHg
Time frame [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]
Secondary outcome
Change in home and office pulse pressure
Time frame [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]
Secondary outcome
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]
Secondary outcome
Change in patient reported outcomes
Time frame [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]
Secondary outcome
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]
Secondary outcome
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]
Secondary outcome
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]
Secondary outcome
Change in home and office heart rate
Time frame [at 3, 6, 12, 24, 36, 48 and 60 months compared to baseline]

Dates

Dates
Start date	June 28, 2024 (actual)
Primary completion	September 1, 2026 (estimated)
Completion	July 1, 2031 (estimated)
First posted	March 7, 2024 (actual)
Last updated	August 12, 2026
Results posted	Not stated in the registry record
Status last verified	August 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

43 sites are recruiting

United States

United States
Facility	City	State or region	Status
Albany Medical Center	Albany	New York	Recruiting
Rocky Mountain Regional VAMC	Aurora	Colorado	Recruiting
Ascension Seton	Austin	Texas	Recruiting
The Brigham and Women's Hospital	Boston	Massachusetts	Recruiting
Massachusetts General Hospital	Boston	Massachusetts	Recruiting
Bridgeport Hosptial	Bridgeport	Connecticut	Recruiting
NewYork-Presbyterian Brooklyn Methodist Hospital	Brooklyn	New York	Recruiting
University at Buffalo	Buffalo	New York	Recruiting
University of North Carolina at Chapel Hill School of Medicine	Chapel Hill	North Carolina	Recruiting
Medical University of South Carolina	Charleston	South Carolina	Recruiting
Prisma Health Richland Hospital	Columbia	South Carolina	Recruiting
Metropolitan Heart & Vascular Institute	Coon Rapids	Minnesota	Recruiting
Dallas VAMC	Dallas	Texas	Recruiting
Henry Ford St. John Hospital	Detroit	Michigan	Recruiting
Henry Ford Health	Detroit	Michigan	Recruiting
Durham VA Health System	Durham	North Carolina	Recruiting
Inova Fairfax Hospital	Fairfax	Virginia	Recruiting
The Cardiac & Vascular Institute	Gainesville	Florida	Recruiting
UPMC Harrisburg	Harrisburg	Pennsylvania	Recruiting
Saint Luke's Mid America Heart Institute	Kansas City	Missouri	Recruiting
TCR Institute	Kingwood	Texas	Recruiting
Tibor Rubin VA Medical Center	Long Beach	California	Recruiting
Cedars-Sinai Medical Center	Los Angeles	California	Recruiting
Medical Center of the Rockies	Loveland	Colorado	Recruiting
Wellstar Kennestone Hospital	Marietta	Georgia	Recruiting
Virtua Health	Marlton	New Jersey	Recruiting
University of Miami Health System	Miami	Florida	Recruiting
Ascension Saint Thomas	Nashville	Tennessee	Recruiting
Touro Infirmary	New Orleans	Louisiana	Recruiting
Columbia University Medical Center/New York Presbyterian Hospital	New York	New York	Recruiting
NYU Langone Health - Bellevue Hosptial	New York	New York	Recruiting
Ascension Sacred Heart	Pensacola	Florida	Recruiting
Penn Medicine	Phildelphia	Pennsylvania	Recruiting
Sutter Institute for Medical Research	Sacramento	California	Recruiting
UC Davis Medical Center	Sacramento	California	Recruiting
St. Mark's Hospital	Salt Lake City	Utah	Recruiting
Pacific Heart Institute	Santa Monica	California	Recruiting
Swedish Medical Center	Seattle	Washington	Recruiting
Spartanburg Regional Medical Center	Spartanburg	South Carolina	Recruiting
Southern Illinois University, Memorial Medical Center	Springfield	Illinois	Recruiting
Stony Brook Medicine	Stony Brook	New York	Recruiting
Tampa Cardiovascular Interventions and Research	Tampa	Florida	Recruiting
Ascension via Christi St. Francis	Wichita	Kansas	Recruiting

Study documents

No documents are linked in this registry record.

Changes over time

August 12, 2026
Site added
4 sites added (43 total)
3943

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT06297291

Categories

Registered in 1 registry

Interested in this study?

How this study is set up

Summary

Conditions

Eligibility

Study population

Eligibility as written in the registry

Eligibility in plain statements

Study design

Sponsor and collaborators

Arms and interventions

Interventions

Outcome measures

Dates

Locations

United States

Study documents

Changes over time