Overview

This trial is active, not recruiting.

Condition uncontrolled hypertension
Treatment mdt-2211 renal denervation system
Phase phase 3
Sponsor Medtronic Vascular
Start date July 2012
End date April 2015
Trial size 41 participants
Trial identifier NCT01644604, MDT2-11-07

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Subjects are treated with the renal denervation procedure after randomization and are maintained on baseline anti-hypertensive medications.
mdt-2211 renal denervation system
A percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery.
(No Intervention)
Subjects are maintained on baseline anti-hypertensive medications

Primary Outcomes

Measure
Change in Office Systolic Blood Pressure
time frame: Baseline to 6 months post-randomization

Secondary Outcomes

Measure
Incidence of Major Adverse Events (MAE)
time frame: Baseline through 1 month post-randomization

Eligibility Criteria

Male or female participants from 20 years up to 80 years old.

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.

Additional Information

Official title The Clinical Study of Renal Denervation by MDT-2211 System in Patients With Uncontrolled Hypertension
Principal investigator Kazuyuki Shimada, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Medtronic Vascular.