Global Paradise System US Post Approval Study
The Global Paradise® System US Post Approval Study (US GPS)
ReCor Medical, Inc.
1,000 participants
Jun 28, 2024
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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 Criteria13
- 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
Interventions
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.
Locations(34)
View Full Details on ClinicalTrials.gov
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NCT06297291