Loading clinical trials...

Renal Denervation by MDT-2211 System in Patients With Uncontrolled Hypertension | Clinical Trials | Clareo Health

COMPLETEDNA

Renal Denervation by MDT-2211 System in Patients With Uncontrolled Hypertension

The Clinical Study of Renal Denervation by MDT-2211 System in Patients With Uncontrolled Hypertension

NCT01644604•Medtronic Vascular

Summary

The objective of this study is to demonstrate that the MDT-2211 renal denervation system is a safe and effective treatment for uncontrolled hypertension subjects despite treatment with 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic, as best available antihypertensive therapy

Detailed Description

The HTN-J study is a multi-center, prospective, unblinded, randomized, controlled study of the safety and effectiveness of renal denervation in subjects with uncontrolled hypertension. Bilateral renal denervation will be performed using the MDT-2211 renal denervation system - a percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery.

Eligibility

Age

20 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Individual is ≥ 20 and ≤ 80 years old at time of randomization.
•Individual is receiving a stable medication regimen including full tolerated doses of 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic (with no changes for a minimum of 6 weeks prior to screening) that is expected to be maintained without changes for at least 6 months.
•Individual has an office systolic blood pressure (SBP) of ≥ 160 mmHg based on an average of 3 blood pressure readings measured at both an initial screening visit and a confirmatory screening visit
•Individual agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study.

Exclusion Criteria

•Individual has an estimated glomerular filtration rate (eGFR) of \< 45 mL/min/1.73 m2
•Individual has an Ambulatory Blood Pressure Monitoring (ABPM) 24 hour average SBP \< 135 mmHg
•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 (17)

Hirosaki University School of Medicine & Hospital

Hirosaki-shi, Aomori, Japan

Chiba University Hospital

Chiba, Chiba, Japan

Ehime University Hospital

Tōon, Ehime, Japan

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Kurume University Hospital

Kurume-shi, Fukuoka, Japan

Asahikawa Medical University Hospital

Asahikawa, Hokkaido, Japan

Sapporo Medical University Hospital

Sapporo, Hokkaido, Japan

Higashi Takarazuka Satoh Hospital

Takarazuka, Hyōgo, Japan

Tsukuba University Hospital

Tsukuba, Ibaraki, Japan

Shonan Kamakura General Hospital

Kamakura, Kanagawa, Japan

Key Dates

Start Date

July 1, 2012

Primary Completion Date

April 1, 2015

Completion Date

June 1, 2017

Last Updated

July 2, 2017

Enrollment

ACTUAL participants

Conditions

Uncontrolled Hypertension

Interventions

MDT-2211 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: July 2, 2017Data 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

Renal Denervation by MDT-2211 System in Patients With Uncontrolled Hypertension

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)