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NCT06297291ClinicalTrials.gov

Global Paradise System US Post Approval Study

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

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

باختصار

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…

رصديةمطلوب 1,000 مشارك43 موقعاًدولة واحدة

الفئات

القلب والأوعية الدموية94%الكلى والمسالك البولية6%

مسجَّلة في سجل واحد

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.

هل أنت مهتم بهذه الدراسة؟

تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.

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.

ملخص

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.

الحالات

  • Hypertension
  • Cardiovascular Diseases
  • Vascular Diseases

الأهلية

الجنسالجميع
الأعمار18 Years – لا حد أقصى
المتطوعون الأصحّاءلا
طريقة أخذ العيناتNON_PROBABILITY_SAMPLE

مجتمع الدراسة

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.

الأهلية كما كُتبت في السجل

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

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

نوع الدراسةرصدية
المرحلةغير مذكور في سجل السجل
التخصيصغير مذكور في سجل السجل
نموذج التدخّلغير مذكور في سجل السجل
الغرض الأساسيغير مذكور في سجل السجل
التعميةغير مذكور في سجل السجل
التجنيدمطلوب 1,000 مشارك

الجهة الراعية والمتعاونون

  • ReCor Medical, Inc. الجهة الراعية

الأذرع والتدخلات

  • 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.

التدخلات

  • جهاز 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.

مقاييس النتائج

  1. مقياس النتيجة الأولي

    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

    الإطار الزمني Baseline to 3-months post-procedure

  2. مقياس النتيجة الأولي

    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)

    الإطار الزمني Baseline to 3-months post-procedure

  3. مقياس النتيجة الثانوي

    Change in mean home systolic/diastolic BP in mmHg

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

  4. مقياس النتيجة الثانوي

    Change in mean office systolic/diastolic BP in mmHg

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

  5. مقياس النتيجة الثانوي

    Change in home and office pulse pressure

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

  6. مقياس النتيجة الثانوي

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

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

  7. مقياس النتيجة الثانوي

    Change in patient reported outcomes

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

  8. مقياس النتيجة الثانوي

    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)

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

  9. مقياس النتيجة الثانوي

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

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

  10. مقياس النتيجة الثانوي

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

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

  11. مقياس النتيجة الثانوي

    Change in home and office heart rate

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

التواريخ

تاريخ البدء28 يونيو 2024 (فعلي)
الإتمام الأولي1 سبتمبر 2026 (تقديري)
الإتمام1 يوليو 2031 (تقديري)
أول نشر7 مارس 2024 (فعلي)
آخر تحديث12 أغسطس 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةأغسطس 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

43 موقعاً قيد التجنيد

United States

المنشأةالمدينةالولاية أو المنطقةالحالة
Albany Medical CenterAlbanyNew Yorkقيد التجنيد
Rocky Mountain Regional VAMCAuroraColoradoقيد التجنيد
Ascension SetonAustinTexasقيد التجنيد
The Brigham and Women's HospitalBostonMassachusettsقيد التجنيد
Massachusetts General HospitalBostonMassachusettsقيد التجنيد
Bridgeport HosptialBridgeportConnecticutقيد التجنيد
NewYork-Presbyterian Brooklyn Methodist HospitalBrooklynNew Yorkقيد التجنيد
University at BuffaloBuffaloNew Yorkقيد التجنيد
University of North Carolina at Chapel Hill School of MedicineChapel HillNorth Carolinaقيد التجنيد
Medical University of South CarolinaCharlestonSouth Carolinaقيد التجنيد
Prisma Health Richland HospitalColumbiaSouth Carolinaقيد التجنيد
Metropolitan Heart & Vascular InstituteCoon RapidsMinnesotaقيد التجنيد
Dallas VAMCDallasTexasقيد التجنيد
Henry Ford St. John HospitalDetroitMichiganقيد التجنيد
Henry Ford HealthDetroitMichiganقيد التجنيد
Durham VA Health SystemDurhamNorth Carolinaقيد التجنيد
Inova Fairfax HospitalFairfaxVirginiaقيد التجنيد
The Cardiac & Vascular InstituteGainesvilleFloridaقيد التجنيد
UPMC HarrisburgHarrisburgPennsylvaniaقيد التجنيد
Saint Luke's Mid America Heart InstituteKansas CityMissouriقيد التجنيد
TCR InstituteKingwoodTexasقيد التجنيد
Tibor Rubin VA Medical CenterLong BeachCaliforniaقيد التجنيد
Cedars-Sinai Medical CenterLos AngelesCaliforniaقيد التجنيد
Medical Center of the RockiesLovelandColoradoقيد التجنيد
Wellstar Kennestone HospitalMariettaGeorgiaقيد التجنيد
Virtua HealthMarltonNew Jerseyقيد التجنيد
University of Miami Health SystemMiamiFloridaقيد التجنيد
Ascension Saint ThomasNashvilleTennesseeقيد التجنيد
Touro InfirmaryNew OrleansLouisianaقيد التجنيد
Columbia University Medical Center/New York Presbyterian HospitalNew YorkNew Yorkقيد التجنيد
NYU Langone Health - Bellevue HosptialNew YorkNew Yorkقيد التجنيد
Ascension Sacred HeartPensacolaFloridaقيد التجنيد
Penn MedicinePhildelphiaPennsylvaniaقيد التجنيد
Sutter Institute for Medical ResearchSacramentoCaliforniaقيد التجنيد
UC Davis Medical CenterSacramentoCaliforniaقيد التجنيد
St. Mark's HospitalSalt Lake CityUtahقيد التجنيد
Pacific Heart InstituteSanta MonicaCaliforniaقيد التجنيد
Swedish Medical CenterSeattleWashingtonقيد التجنيد
Spartanburg Regional Medical CenterSpartanburgSouth Carolinaقيد التجنيد
Southern Illinois University, Memorial Medical CenterSpringfieldIllinoisقيد التجنيد
Stony Brook MedicineStony BrookNew Yorkقيد التجنيد
Tampa Cardiovascular Interventions and ResearchTampaFloridaقيد التجنيد
Ascension via Christi St. FrancisWichitaKansasقيد التجنيد

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

  1. 12 أغسطس 2026

    أُضيف موقع

    4 sites added (43 total)

    3943

السجل: ClinicalTrials.gov · NCT########

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