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Procedure

Renal Denervation Therapy for High Blood Pressure

N/A

Waitlist Available

Research Sponsored by DeepQure Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged ≥22 and ≤80 years old at time of enrollment (consent)

Diagnosed with resistant hypertension

Must not have

Has coverage diameter of renal artery less than 2 mm or greater than 11 mm

Has atrial fibrillation patients undergoing treatment and not in sinus rhythm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 1-, 3-, 6-, 12-, 24-, 36-months post-procedure

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to test the safety and effectiveness of a new treatment called the HyperQure RDN System for patients with high blood pressure that is not controlled by three or more medications. It will be

Who is the study for?

This trial is for patients with resistant hypertension who are taking three or more blood pressure medications without success. It's not suitable for individuals with certain types of heart conditions, kidney diseases, or those who've had previous renal artery interventions.

What is being tested?

The study is testing the 'HyperQureTM RDN System', a new laparoscopic procedure aimed at lowering high blood pressure by disrupting nerves in the kidneys that contribute to hypertension.

What are the potential side effects?

Potential side effects may include pain at the incision site, bleeding, infection, and temporary increases in blood pressure post-procedure. Kidney function might also be affected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 22 and 80 years old.

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My high blood pressure does not improve with medication.

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My blood pressure is high and I've been on 3 different blood pressure medicines including a diuretic for over 4 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My renal artery is either less than 2 mm or more than 11 mm wide.

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I have atrial fibrillation and am not in normal heart rhythm despite treatment.

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I have only one working kidney.

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I have a blockage, bulge, or stent near my kidney treatment area.

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I am on dialysis for end-stage kidney disease.

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I have been diagnosed with fibromuscular dysplasia.

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My BMI is over 40.

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My kidney function is reduced.

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I have been diagnosed with high blood pressure in the lungs.

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I have a bleeding disorder or will not accept blood transfusions.

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My blood vessels for renal denervation are at least 30% narrowed.

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I have had a procedure to decrease nerve activity in my kidneys.

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I have polycystic kidney disease.

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I have a shrunken kidney.

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I have had a kidney transplant.

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I have had surgery on both of my kidneys.

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I have had surgery through the back of my abdominal cavity.

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I have scarring in the tissue behind my stomach and intestines.

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I am at risk for high pressure inside my skull.

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I have had treatment for kidney artery problems, like stenting or angioplasty.

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I need oxygen or a ventilator during the day, not just for sleep apnea at night.

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I have high blood pressure that might be caused by another untreated condition or by medications I'm taking.

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I have a surgery planned that could impact the study's results.

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I have a serious heart valve problem that makes lowering my blood pressure dangerous.

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I've been on heart or blood pressure medicine for less than 3 months, and stopping it could be risky.

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I have inflammation in the area behind my stomach and intestines.

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I regularly take NSAIDs for pain at least 2 days a week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 1-, 3-, 6-, 12-, 24-, 36-months post-procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to 1-, 3-, 6-, 12-, 24-, 36-months post-procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 1-, 3-, 6-, 12-, 24-, 36-months post-procedure for reporting.