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Nerve-zapping procedure for high blood pressure put to the test in medicare patients

NCT ID NCT07174622

Disease control Sponsor: Medtronic Vascular Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tracks 1,000 Medicare patients with uncontrolled high blood pressure to see if a procedure called renal denervation (using the Symplicity Spyral device) helps lower blood pressure and prevent heart attacks or strokes over two years. Researchers will compare patients who had the procedure plus standard care to those who only received standard care, using existing health records and insurance claims. The goal is to see if this minimally invasive treatment works well in real-world, older populations.

What this could mean

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

Active substance
Renal denervation (Symplicity Spyral™ device)
What this could lead to
If successful, this could show that renal denervation helps lower blood pressure and reduce heart risks in older adults with hard-to-control hypertension.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by other factors. The procedure is invasive and may not work for everyone.

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 1,000 people

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

Started

Oct 2025

Expected to finish

Jun 2029

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

The study population will consist of patients enrolled in Medicare treated with RDN or on stable antihypertension management in any US location.

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: * Enrolled in a Medicare plan * Diagnosis of uncontrolled hypertension * On a stable regimen of antihypertensive therapy Exclusion Criteria: * A prior RDN procedure * Diagnosis of secondary hypertension * Any condition for which RDN is contraindicated

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder hypertensive disorder vascular disorder

As listed by the trial registrant

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

Cardiovascular diseases Hypertension Vascular diseases

How to take part

Only the study team decides who joins. These are the ways to reach them.

  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.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

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