Completed

HTN-2Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)

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What is being tested

Renal Denervation (Symplicity® Renal Denervation System)

Device
Who is being recruted

Cardiovascular Diseases

+ Hypertension

+ Vascular Diseases

From 18 to 85 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: June 2009
See protocol details

Summary

Principal SponsorMedtronic Vascular
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2009

Actual date on which the first participant was enrolled.

An international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation in patients with uncontrolled hypertension.

Official TitleRenal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)
NCT00888433
Principal SponsorMedtronic Vascular
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

106 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHypertensionVascular Diseases

Criteria

3 inclusion criteria required to participate
systolic blood pressure >=160mmHg (>=150 mmHg for type 2 diabetics);
on 3 or more antihypertensive medications
= 18 and =< 85 years of age.
6 exclusion criteria prevent from participating
renal artery abnormalities
eGFR < 45mL/min
MI, angina, CVA within 6 months
Type 1 diabetes
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Renal Denervation and maintenance of anti-hypertensive medications

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 20 locations

Suspended

Alfred Hospital

Melbourne, AustraliaOpen Alfred Hospital in Google Maps
Suspended

Vienna General Hospital

Vienna, Austria
Suspended

Cliniques Universitaires Saint Luc

Brussels, Belgium
Suspended

Hopital Européen Georges Pompidou

Paris, France
Completed20 Study Centers