Paradise System for High Blood Pressure
Global Paradise System US Post Approval Study
Recruiting
Observational Study
Hypertension
Cardiovascular Diseases
Vascular Diseases
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 1,000 (estimated)
- Sponsor
- ReCor Medical, Inc. · Industry
Who this trial is looking for
This trial is looking for adults with high blood pressure that isn't controlled by lifestyle changes or medications. Participants will receive treatment with the Paradise Ultrasound Renal Denervation System and help researchers understand its long-term safety and effectiveness.
Are You a Good Fit for This Trial?
You may be able to join if
- I have high blood pressure
- I have taken medications for high blood pressure
- My average blood pressure is above 140 mmHg in the clinic
- My average blood pressure at home is above 135 mmHg
- I have signed the study consent form
- My kidney function is acceptable
You may not be able to join if
- I am under 18 years old
- I am pregnant
- I have had a kidney transplant
- I have abnormal kidney tumors
- I don't have the right kidney structure for the treatment
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Check Your Eligibility
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. Informat…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Signed and dated study informed consent
* Documented history of hypertension
* Documented history of prior or current antihypertensive medication(s)
* Baseline seated office systolic BP at screening ≥ 140 mmHg
* Mean pre-procedure home systolic BP of ≥ 135 mmHg
* Estimated glo…
Contacts