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

Overview

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

Full Title of Study: “The Clinical Study of Renal Denervation by MDT-2211 System in Patients With Uncontrolled Hypertension”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2015

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.

Interventions

  • Device: MDT-2211 Renal Denervation System
    • A percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery.

Arms, Groups and Cohorts

  • Experimental: Renal denervation
    • Subjects are treated with the renal denervation procedure after randomization and are maintained on baseline anti-hypertensive medications.
  • No Intervention: Control Group
    • Subjects are maintained on baseline anti-hypertensive medications

Clinical Trial Outcome Measures

Primary Measures

  • Change in Office Systolic Blood Pressure
    • Time Frame: Baseline to 6 months post-randomization

Secondary Measures

  • Incidence of Major Adverse Events (MAE)
    • Time Frame: Baseline through 1 month post-randomization

Participating in This Clinical Trial

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 highlights: – 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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medtronic Vascular
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kazuyuki Shimada, MD, Principal Investigator, New Oyama Municipal Hospital

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