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Clinical Trials in France / NCT07206030
Recruiting Observational

Real Life Data From Hypertensive Patients Treated With Renal Denervation in Current Practice in France- French RENal Denervation Registry

NCT07206030 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Grenoble
Phase
Observational
Started
2025-06-23
Last updated
2025-10-03

Condition(s) studied

Hypertension (HTN)

Study summary

Renal denervation (RDN) is a recent procedure that can be used to control BP (blood pressure) in hypertensive patients. Numerous publications from randomised trials have demonstrated the efficacy of RDN in this indication. The latest guidelines now include RDN as an effective technique for use in hypertension. Since early 2023, RDN using Medtronic's Spiral radiofrequency system has benefited from transitional authorisation for reimbursement by the French health insurance system. An application for reimbursement is underway for the ultrasound system. We aim to compile an exhaustive prospective register of all procedures carried out in France over the next few years, regardless of the type of catheter used or the context in which the procedure was carried out (transitional reimbursement, industrial register, randomised trial). Our aim is to assess the efficacy and safety of the procedure within the French healthcare system, the characteristics of patients benefiting from the procedure, the centres performing renal denervation, and the care pathways used, and to be able to present all this data, independently of the industry, to the healthcare authorities when it comes time to reassess the value of this procedure and its indications. The goal of this observational study is to learn about changes in blood pressure in patient with high blood pressure before and 1 year after a renal denervation treatment (RDN).

The primary endpoint is to describe changes in systolic blood pressure (SBP) measured by Home Blood Pressure Measurement (HBPM) in patients suffering from high blood pressure, before and 1 year after RDN.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult ( \> 18 years old) hypertensive patients treated with RDN in France whatever the catheter and the indication. This might include retrospective data for patient already treated with RDN in the past. Exclusion Criteria: * RDN not proposed to the patient, patient opposing the collection and use of his/her data for research purposes.

Primary outcome measure(s)

  • Change in SBP measured by HBPM before and after RDN (1 year). — before intervention and 1 year after intervention
    Measurement of home blood pressure before and 1 year after RDN

Trial sites (1)

FacilityCityRegionStatus
Chu Grenoble Alpes La Tronche France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07206030 on ClinicalTrials.gov ↗ ← All trials in France