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.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
3,000 (estimated)
Sponsor
ReCor Medical, Inc. · Industry
Who this trial is looking for
This trial is looking for adults with high blood pressure who might benefit from a specific treatment called the Paradise Ultrasound Renal Denervation System. Participants will have regular blood pressure measurements taken at home and complete a quality of life questionnaire.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old
I have given my informed consent
I am a candidate for renal denervation treatment based on my doctor's assessment
I have used the Paradise System in the last 6 months
You may not be able to join if
I am under 18 years old
I am pregnant
I have an allergy to contrast medium
I have a stented renal artery
My renal arteries are too small or too large
I have fibromuscular disease in my renal artery
I have a renal artery aneurysm
I have severe renal artery narrowing
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.
The GPS Registry is a multi-centre, single-arm, non-interventional (observational) registry. In addition to collecting data from patients treated as per standard clinical practice, the Registry will also regularly collect telemetric Home Blood Pressure (HBP) measurements and Patient Reported Outcome (PRO) data via a standardized quality of life questionnaire. The objective of the GPS Registry is t…
The GPS Registry is a multi-centre, single-arm, non-interventional (observational) registry. In addition to collecting data from patients treated as per standard clinical practice, the Registry will also regularly collect telemetric Home Blood Pressure (HBP) measurements and Patient Reported Outcome (PRO) data via a standardized quality of life questionnaire. The objective of the GPS Registry is to document the long-term safety and effectiveness of the commercially available Paradise Ultrasound Renal Denervation System when used per its labelling in patients deemed to be candidates for RDN as per physician's assessment.
Trial Locations
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City
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Status
Eligibility Criteria
Inclusion Criteria:
* Appropriately signed and dated informed consent
* Age ≥18 at time of consent
* Patient candidate for renal denervation with the Paradise System based on physician's assessment OR Patient treated with the Paradise Ultrasound Renal Denervation System within the 6 months prior to…
Inclusion Criteria:
* Appropriately signed and dated informed consent
* Age ≥18 at time of consent
* Patient candidate for renal denervation with the Paradise System based on physician's assessment OR Patient treated with the Paradise Ultrasound Renal Denervation System within the 6 months prior to consent
Exclusion Criteria:
Patients who meet any of the contraindications listed in the Instructions for Use will be excluded.
The contraindications are:
* Stented renal artery
* Less than 18 years of age
* Pregnant
* Known allergy to contrast medium
* Renal arteries diameter \< 3 mm and \> 8 mm
* Renal artery with Fibromuscular (FMD) disease
* Renal artery aneurysm
* Renal artery stenosis of any origin \>30%
* Iliac/femoral artery stenosis precluding insertion of the Paradise catheter
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