Registry documenting long-term safety and effectiveness of renal denervation for hypertension
Official title: Global SYMPLICITY Registry (GSR) Denervation Findings in Real World (DEFINE)
Run by Medtronic Vascular · NCT01534299 · Data updated 2026-11-12
This study is trying to see how safe and effective renal denervation is for people with high blood pressure over the long term.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 5000 (estimated) |
| Sponsor | Medtronic Vascular Industry-sponsored |
| Locations | 2 sites (Homburg, Saarlandes and 1 other locations) |
| Status | Recruiting |
| Started | February 2012 |
| Main results expected | June 2027 |
| Study ends | December 2031 |
| Registry record updated | October 23, 2026 |
| Trial ID | NCT01534299 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this registry are adults aged 18 and older with uncontrolled hypertension who are suitable for renal denervation.
✕Probably not a fit
Patients with controlled hypertension or those not eligible for renal denervation may not benefit from this registry.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, multi-center, single-arm, non-interventional registry aimed at documenting the long-term safety and effectiveness of renal denervation in patients with hypertension. Approximately 5000 patients will be enrolled from over 300 sites worldwide, with follow-up ranging from 1 to 5 years post-procedure. Data collected will include blood pressure measurements, medication changes, and clinical data related to hypertension. The registry will help expand the knowledge base regarding the Medtronic renal denervation system in a real-world patient population.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the long-term management of hypertension through renal denervation.
How similar studies have gone: Other studies on renal denervation have shown promise, suggesting that this approach may be effective in managing hypertension.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Age ≥ 18 years or minimum age as required by local regulations
* The patient is an acceptable candidate for renal denervation based upon the Instructions For Use for the Medtronic renal denervation system. The procedure must be performed with an initial use, market-released Medtronic renal denervation catheter.
* The patient or legal representative has been informed of the nature of the registry has consented to participate and authorized the collection and release of this medical information by signing a consent form ("Patient Informed Consent Form" or "Patient Data Release Authorization Form")
Where it's running
-
Universitätsklinikum des Saarlandes
Homburg, Saarlandes, Germany Recruiting -
Universitätsspital Basel
Basel, Switzerland, Switzerland Recruiting
Study contacts
- Principal investigator: Michael Böhm, Prof. — University Hospital, Saarland
- Study coordinator: K. Wandrey
- Email: rs.medtroniccardiovascularclinicaltrials@medtronic.com
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Using low-dose aspirin after preeclampsia to improve recovery
This study is testing if taking low-dose aspirin for six months after having preeclampsia can help new moms recover better by improving their blood pressure and blood vessel function.
-
IMB-guided health education to boost medication taking and blood pressure control in adults with hypertension
This study tests a health-literacy program based on Information-Motivation-Behavioral Skills to help adults with hypertension who don’t take their medicines regularly to take them more consistently and better control their blood pressure.
-
Renal Nerve Stimulation to Help Blood Pressure in AF and HFpEF
This study tests whether stimulating the kidneys with a catheter can safely lower blood pressure in adults with atrial fibrillation and HFpEF who also have hypertension.
-
Hypertension: Does Education Help Patients Manage Blood Pressure Better?
This study tests whether structured patient education improves blood pressure control and self-management in adults with hypertension who speak Turkish.
-
High BMI and periodontitis in Thai adults under 60
This study tests how common high BMI and periodontitis are among Thai adults aged 18–59 and what factors are linked to them.
-
Long-term GW906 treatment for people with essential hypertension
This trial tests whether long-term GW906 injections are safe and effective for adults with essential hypertension who completed an earlier GW906 study.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.