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NCT06297291ClinicalTrials.gov

Global Paradise System US Post Approval Study

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

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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…

Beobachtend1.000 Teilnehmende gesucht43 Studienzentren1 Land

Kategorien

Herz-Kreislauf94%Nephrologie und Urologie6%

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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.

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

Zusammenfassung

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.

Erkrankungen

  • Hypertension
  • Cardiovascular Diseases
  • Vascular Diseases

Eignung

GeschlechtAlle
Alter18 Years – Kein Höchstalter
Gesunde FreiwilligeNein
StichprobenverfahrenNON_PROBABILITY_SAMPLE

Studienpopulation

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.

Eignung im Wortlaut des Registers

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

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

StudientypBeobachtend
PhaseIm Registereintrag nicht angegeben
ZuteilungIm Registereintrag nicht angegeben
InterventionsmodellIm Registereintrag nicht angegeben
Primäres ZielIm Registereintrag nicht angegeben
VerblindungIm Registereintrag nicht angegeben
Teilnahme1.000 Teilnehmende gesucht

Sponsor und Mitwirkende

  • ReCor Medical, Inc. Sponsor

Studienarme und Interventionen

  • 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.

Interventionen

  • Medizinprodukt 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.

Endpunkte

  1. Primärer Endpunkt

    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

    Zeitrahmen Baseline to 3-months post-procedure

  2. Primärer Endpunkt

    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)

    Zeitrahmen Baseline to 3-months post-procedure

  3. Sekundärer Endpunkt

    Change in mean home systolic/diastolic BP in mmHg

    Zeitrahmen [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]

  4. Sekundärer Endpunkt

    Change in mean office systolic/diastolic BP in mmHg

    Zeitrahmen [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]

  5. Sekundärer Endpunkt

    Change in home and office pulse pressure

    Zeitrahmen [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]

  6. Sekundärer Endpunkt

    Change in the number and/or dosage and/or type of antihypertensive medications taken

    Zeitrahmen [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]

  7. Sekundärer Endpunkt

    Change in patient reported outcomes

    Zeitrahmen [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]

  8. Sekundärer Endpunkt

    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)

    Zeitrahmen [baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]

  9. Sekundärer Endpunkt

    Percentage of patients who demonstrate a reduction in home systolic BP of ≥ 5mmHg, ≥ 10 mmHg and ≥ 15 mmHg

    Zeitrahmen [at 3, 6, 12, 24, 36, 48 and 60 months compared to baseline]

  10. Sekundärer Endpunkt

    Percentage of patients who demonstrate a reduction in office systolic BP of ≥ 5mmHg, ≥ 10 mmHg and ≥ 15 mmHg

    Zeitrahmen [at 3, 6, 12, 24, 36, 48 and 60 months compared to baseline]

  11. Sekundärer Endpunkt

    Change in home and office heart rate

    Zeitrahmen [at 3, 6, 12, 24, 36, 48 and 60 months compared to baseline]

Daten

Startdatum28. Juni 2024 (tatsächlich)
Primärer Abschluss1. September 2026 (geschätzt)
Abschluss1. Juli 2031 (geschätzt)
Erstveröffentlichung7. März 2024 (tatsächlich)
Zuletzt aktualisiert12. August 2026
Ergebnisse veröffentlichtIm Registereintrag nicht angegeben
Status zuletzt bestätigtAugust 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

43 Studienzentren rekrutieren

United States

EinrichtungStadtBundesland oder RegionStatus
Albany Medical CenterAlbanyNew YorkRekrutiert
Rocky Mountain Regional VAMCAuroraColoradoRekrutiert
Ascension SetonAustinTexasRekrutiert
The Brigham and Women's HospitalBostonMassachusettsRekrutiert
Massachusetts General HospitalBostonMassachusettsRekrutiert
Bridgeport HosptialBridgeportConnecticutRekrutiert
NewYork-Presbyterian Brooklyn Methodist HospitalBrooklynNew YorkRekrutiert
University at BuffaloBuffaloNew YorkRekrutiert
University of North Carolina at Chapel Hill School of MedicineChapel HillNorth CarolinaRekrutiert
Medical University of South CarolinaCharlestonSouth CarolinaRekrutiert
Prisma Health Richland HospitalColumbiaSouth CarolinaRekrutiert
Metropolitan Heart & Vascular InstituteCoon RapidsMinnesotaRekrutiert
Dallas VAMCDallasTexasRekrutiert
Henry Ford St. John HospitalDetroitMichiganRekrutiert
Henry Ford HealthDetroitMichiganRekrutiert
Durham VA Health SystemDurhamNorth CarolinaRekrutiert
Inova Fairfax HospitalFairfaxVirginiaRekrutiert
The Cardiac & Vascular InstituteGainesvilleFloridaRekrutiert
UPMC HarrisburgHarrisburgPennsylvaniaRekrutiert
Saint Luke's Mid America Heart InstituteKansas CityMissouriRekrutiert
TCR InstituteKingwoodTexasRekrutiert
Tibor Rubin VA Medical CenterLong BeachCaliforniaRekrutiert
Cedars-Sinai Medical CenterLos AngelesCaliforniaRekrutiert
Medical Center of the RockiesLovelandColoradoRekrutiert
Wellstar Kennestone HospitalMariettaGeorgiaRekrutiert
Virtua HealthMarltonNew JerseyRekrutiert
University of Miami Health SystemMiamiFloridaRekrutiert
Ascension Saint ThomasNashvilleTennesseeRekrutiert
Touro InfirmaryNew OrleansLouisianaRekrutiert
Columbia University Medical Center/New York Presbyterian HospitalNew YorkNew YorkRekrutiert
NYU Langone Health - Bellevue HosptialNew YorkNew YorkRekrutiert
Ascension Sacred HeartPensacolaFloridaRekrutiert
Penn MedicinePhildelphiaPennsylvaniaRekrutiert
Sutter Institute for Medical ResearchSacramentoCaliforniaRekrutiert
UC Davis Medical CenterSacramentoCaliforniaRekrutiert
St. Mark's HospitalSalt Lake CityUtahRekrutiert
Pacific Heart InstituteSanta MonicaCaliforniaRekrutiert
Swedish Medical CenterSeattleWashingtonRekrutiert
Spartanburg Regional Medical CenterSpartanburgSouth CarolinaRekrutiert
Southern Illinois University, Memorial Medical CenterSpringfieldIllinoisRekrutiert
Stony Brook MedicineStony BrookNew YorkRekrutiert
Tampa Cardiovascular Interventions and ResearchTampaFloridaRekrutiert
Ascension via Christi St. FrancisWichitaKansasRekrutiert

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

  1. 12. August 2026

    Studienzentrum hinzugefügt

    4 sites added (43 total)

    3943

Register: ClinicalTrials.gov · NCT########

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