Global Paradise System US Post Approval Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorReCor Medical, Inc.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Paradise Ultrasound Renal Denervation Treatment
DeviceThe 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.
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: Prospective Ultrasound Renal Denervation Treatment1 intervention
Group B: RADIANCE CAP Transfer0 interventions
Trial outcomes
Primary outcomes
1
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-procedure2
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-procedureSecondary outcomes
1
Change in mean home systolic/diastolic BP in mmHg
Time frame
[baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]2
Change in mean office systolic/diastolic BP in mmHg
Time frame
[baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]3
Change in home and office pulse pressure
Time frame
[baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months]4
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]Sponsors and contacts
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Source ClinicalTrials.gov