Resistant HypertensionNCT07081243
Symplicity China Study
An observational study of Resistant Hypertension, run by Medtronic Vascular at 1 site in China.
Trial summary
The Symplicity China study will evaluate the real-world long-term safety, efficacy, and durability of the Symplicity Spyral system in a population of approximately 500 renal denervation treated subjects with up to 36 months of follow up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resistant Hypertension
- What is being tested?
- Symplicity Spyral Renal Denervation System
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2025to 30 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Aged 18 years or older.
- 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.
- 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.
Who cannot join
- At least one main renal artery with a diameter less than 3 mm or greater than 8 mm.
- Presence of fibromuscular dysplasia.
- Renal artery stent placement within 3 months prior to the procedure.
- Presence of Renal artery aneurysms.
- Presence of more than 50% stenosis in any treatable vessel.
- Pregnant.
- Present of renal or adrenal tumors.
- Iliac/femoral artery stenosis prevents catheter insertion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 210000
Zhifeng Yao, 0086-21-64041990, zhifengyao@126.com
About this study
Official title: A Prospective, Single-group, Non-interventional, Non-blinded, Observational Study to Evaluate the Long-term Safety, Efficacy, and Durability of Symplicity Spyral Renal Denervation System in China
The Symplicity China study will evaluate the real-world long-term safety, efficacy, and durability of the Symplicity Spyral system in a population of approximately 500 renal denervation treated subjects with up to 36 months of follow up.
- Conditions
- Resistant Hypertension
- Being tested
- Symplicity Spyral Renal Denervation System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symplicity Spyral Renal Denervation SystemDevice
Symplicity Renal Denervation
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective: Change in systolic blood pressure (SBP) from baseline to 6 months post-procedure as measured by office blood pressure.
Measured: 6 months post-procedure
Secondary outcomes (7)
Changes in office blood pressure
Measured: 1, 3, 6, 12, 24 and 36 months post-procedure
Changes in home blood pressure
Measured: 1, 3, 6, 12, 24 and 36 months post-procedure
Changes in 24-hour ambulatory blood pressure
Measured: 1, 3, 6, 12, 24 and 36 months post-procedure
Changes of Number of medications
Measured: 1, 3, 6, 12, 24 and 36 months post-procedure
Changes of Medication burden
Measured: 1, 3, 6, 12, 24 and 36 months post-procedure
Proportion of subjects achieving blood pressure reduction and control to ≤140 mmHg (measured by OBP, HBP, and ABPM)
Measured: 1, 3, 6, 12, 24 and 36 months post-procedure
Event rates
Measured: 1, 3, 6, 12, 24 and 36 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start11 Nov 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistant HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081243
- Sponsor's protocol ID
- MDT24050
- Status last verified
- Nov 2025
- First submitted
- 3 Jul 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-group, Non-interventional, Non-blinded, Observational Study to Evaluate the Long-term Safety, Efficacy, and Durability of Symplicity Spyral Renal Denervation System in China
- ClinicalTrials.gov ID
- NCT07081243
- Acronym / sponsor ID
- MDT24050
- Conditions
- Resistant Hypertension
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Medtronic VascularIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Dec 2031 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Symplicity China study will evaluate the real-world long-term safety, efficacy, and durability of the Symplicity Spyral system in a population of approximately 500 renal denervation treated subjects with up to 36 months of follow up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Aged 18 years or older.
- 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.
- 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.
Key exclusion criteria (8 listed)
- At least one main renal artery with a diameter less than 3 mm or greater than 8 mm.
- Presence of fibromuscular dysplasia.
- Renal artery stent placement within 3 months prior to the procedure.
- Presence of Renal artery aneurysms.
- Presence of more than 50% stenosis in any treatable vessel.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Symplicity Spyral Renal Denervation SystemSymplicity Renal Denervation | Device | – |
Primary outcome
Primary Objective: Change in systolic blood pressure (SBP) from baseline to 6 months post-procedure as measured by office blood pressure.
Time frame: 6 months post-procedure
7 secondary outcomes
Changes in office blood pressure
Time frame: 1, 3, 6, 12, 24 and 36 months post-procedure
Changes in home blood pressure
Time frame: 1, 3, 6, 12, 24 and 36 months post-procedure
Changes in 24-hour ambulatory blood pressure
Time frame: 1, 3, 6, 12, 24 and 36 months post-procedure
Changes of Number of medications
Time frame: 1, 3, 6, 12, 24 and 36 months post-procedure
Changes of Medication burden
Time frame: 1, 3, 6, 12, 24 and 36 months post-procedure
Proportion of subjects achieving blood pressure reduction and control to ≤140 mmHg (measured by OBP, HBP, and ABPM)
Time frame: 1, 3, 6, 12, 24 and 36 months post-procedure
Event rates
Time frame: 1, 3, 6, 12, 24 and 36 months post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resistant Hypertension, run by Medtronic Vascular at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective: Change in systolic blood pressure (SBP) from baseline to 6 months post-procedure as measured by office blood pressure. (time frame: 6 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.