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Multi-electrode Radiofrequency Renal Denervation System Feasibility Study | Clinical Trials | Clareo Health

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Multi-electrode Radiofrequency Renal Denervation System Feasibility Study

NCT01699529•Medtronic Vascular

Summary

This is a prospective, single-arm, non-randomized and open label feasibility study. The study is intended to evaluate safety and efficacy of multi-electrode radiofrequency renal denervation in patients with uncontrolled hypertension.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Individual is ≥ 18 and ≤ 80 years old.
•Individual has an office systolic blood pressure of 160 mmHG or greater (≥ 150 mmHg for Type 2 diabetics) based on an average of 3 office/clinic blood pressure readings
•Individual is adhering to a stable medication regimen including ≥ 3 anti-hypertensive medications(preferred that one is a diuretic) for a minimum of two weeks prior to screening.

Exclusion Criteria

•Individual has an estimated glomerular filtration rate (eGFR) of \< 45 mL/min/1.73 m2
•Individual has type 1 diabetes mellitus
•Individual requires chronic oxygen support or mechanical ventilation (e.g., tracheostomy, CPAP, BiPAP) other than nocturnal respiratory support for sleep apnea.
•Individual has primary pulmonary hypertension.
•Individual is pregnant, nursing or planning to be pregnant.

Locations (4)

Alfred Hospital

Melbourne, Victoria, Australia

St. Vincent's Hospital Melbourne

Melbourne, Victoria, Australia

Epworth Hospital

Melbourne, Victoria, Australia

Wellington Hospital

Wellington, Wellington Region, New Zealand

Key Dates

Start Date

September 1, 2012

Primary Completion Date

March 1, 2014

Completion Date

October 1, 2016

Last Updated

October 26, 2016

Enrollment

ACTUAL participants

Conditions

Uncontrolled Hypertension

Interventions

Medtronic Multi-electrode Radiofrequency (RF) Renal Denervation system

DEVICE

Intensification of Blood Pressure Lowering Therapeutics Based on Diuretics Versus Usual Management for Uncontrolled Hypertension IN Patients With Moderate to Severe Chronic Kidney Disease

NCT05732727

Chronic Kidney Disease(CKD)Uncontrolled Hypertension

View study

RECRUITINGPHASE2

A Study of Modified Release RTN-001 In Patients With Uncontrolled Hypertension

NCT07142356

Uncontrolled Hypertension

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 26, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Multi-electrode Radiofrequency Renal Denervation System Feasibility Study

Inclusion Criteria

Exclusion Criteria

Intensification of Blood Pressure Lowering Therapeutics Based on Diuretics Versus Usual Management for Uncontrolled Hypertension IN Patients With Moderate to Severe Chronic Kidney Disease

A Study of Modified Release RTN-001 In Patients With Uncontrolled Hypertension

Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity

A Study to Evaluate Cortisol Reserve in Response to Adrenocorticotropic Hormone (ACTH) Stimulation Test Following Baxdrostat Treatment Compared to Placebo in Participants With Uncontrolled Hypertension

A Phase I Trial of QLS1410 in Healthy Chinese Adults and Participants With Mild Essential Hypertension

Uncontrolled Hypertension Management (TEAM-HTN)