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.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
1,000 (estimated)
Sponsor
ReCor Medical, Inc. · Industry
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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) * Mean seated office systolic BP at screening ≥ 140 mmHg * Mean pre-procedure home systolic BP of ≥ 135 mmHg * Estimated glomeru…
Contacts

Helen Reeve-Stoffer, PhD

+1 650-912-9032

hreeve-stoffer@recormedical.com

CONTACT

Liz Sheehan

Liz.Sheehan@recormedical.com

CONTACT