New device could help patients with Hard-to-Control blood pressure

NCT ID NCT07081243

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 500 people in China with resistant hypertension who have already received the Symplicity Spyral renal denervation system. The device uses radiofrequency energy to calm overactive kidney nerves that can raise blood pressure. Researchers will track blood pressure changes, medication use, and safety for up to 36 months to see if the treatment provides lasting benefits.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Symplicity Spyral Renal Denervation System (a device that uses radiofrequency energy to disrupt nerves in the kidney arteries to lower blood pressure)
What this could lead to
If successful, this could confirm that renal denervation provides lasting blood pressure reduction for people with resistant hypertension, offering an alternative to lifelong medication.
What could go wrong
This is an observational study, not a randomized trial, so results may be less definitive. The device is already approved, but long-term durability and safety in a real-world Chinese population are still being assessed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients diagnosed with resistant hypertension or antihypertensive drug intolerance. Resistant hypertension, defined as having an office systolic blood pressure (SBP) ≥140 mmHg despite appropriate lifestyle measures and being treated with three or more antihypertensive medications (including a diuretic) for more than 3 months. Drug intolerance, defined as patients who cannot tolerate medication due to contraindications or adverse effects.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Aged 18 years or older. 2. Patients diagnosed with resistant hypertension or antihypertensive drug intolerance and treated with Symplicity Spyral Renal Denervation System. Resistant hypertension, defined as having an office systolic blood pressure (SBP) ≥140 mmHg despite appropriate lifestyle measures and being treated with three or more antihypertensive medications (including a diuretic) for more than 3 months; or drug intolerance, defined as patients who cannot tolerate medication due to contraindications or adverse effects. 3. The patient voluntarily undergoes renal denervation; the patient has been informed of the observational nature of the study; the patient voluntarily provides written informed consent ("Patient Informed Consent Form") and willingly participates in the study. Exclusion Criteria: 1. At least one main renal artery with a diameter less than 3 mm or greater than 8 mm. 2. Presence of fibromuscular dysplasia. 3. Renal artery stent placement within 3 months prior to the procedure. 4. Presence of Renal artery aneurysms. 5. Presence of more than 50% stenosis in any treatable vessel. 6. Pregnant. 7. Present of renal or adrenal tumors. 8. Iliac/femoral artery stenosis prevents catheter insertion.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Zhongshan Hospital Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 210000, China

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