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Prediction of Blood Pressure Outcomes Following Renal Denervation (PREDICT-RDN)

NCT06845579 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-06-24

No results posted yet for this study

Summary

Prospective, single arm trial to assess the effects of renal denervation on day-by-day blood pressure measurements and time in blood pressure target range, as well as establish a multivariate prediction model for blood pressure reduction after renal denervation.

Conditions

  • Uncontrolled Arterial Hypertension

Interventions

PROCEDURE

Renal sympathetic denervation

All procedures will be carried out by highly experienced interventional cardiologists, each having performed a minimum of 20 RDN prior to treating study patients. All interventions will be performed with the CE-marked Symplicity SpyralTM (Medtronic, Minneapolis, MN, USA) renal denervation system following current treatment standards. Procedures will be performed as stated in the IFU. The specific ablation points will be determined by the discretion of the interventionalist.

Sponsors & Collaborators

  • Helios Health Institute GmbH

    collaborator OTHER

  • Heart Center Leipzig - University Hospital

    lead OTHER

Principal Investigators

  • Karl Fengler, Dr. med. · Heart Center Leipzig

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2027-02-28
Completion
2028-02-29

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06845579 on ClinicalTrials.gov