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

Uncontrolled Hypertension Clinical Trial

— HTN-J  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01644604
• Other study ID #: MDT2-11-07
• Status: Completed
• Phase: N/A
• First received: June 29, 2012
• Last updated: June 30, 2017
• Start date: July 2012
• Est. completion date: June 2017

Study information

• Verified date: June 2017
• Source: Medtronic Vascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 2017
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Uncontrolled Hypertension

Intervention

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

Locations

Country	Name	City	State
Japan	Asahikawa Medical University Hospital	Asahikawa	Hokkaido
Japan	Chiba University Hospital	Chiba-shi	Chiba
Japan	Mitsui Memorial Hospital	Chiyoda-ku	Tokyo
Japan	Kyushu University Hospital	Fukuoka-shi	Fukuoka
Japan	Hirosaki University School of Medicine & Hospital	Hirosaki-shi	Aomori
Japan	Shonan Kamakura General Hospital	Kamakura	Kanagawa
Japan	Kumamoto University Hospital	Kumamoto-shi	Kumamoto
Japan	Kurume University Hospital	Kurume-shi	Fukuoka
Japan	Kyoto University Hospital	Sakyo-ku	Kyoto
Japan	Sapporo Medical University Hospital	Sapporo-shi	Hokkaido
Japan	Jichi Medical University Hospital	Shimotsuke	Tochigi
Japan	Tokyo Women's Medical University Hospital	Shinjuku-ku	Tokyo
Japan	Osaka University Hospital	Suita-shi	Osaka
Japan	Higashi Takarazuka Satoh Hospital	Takarazuka	Hyogo
Japan	Ehime University Hospital	Toon	Ehime
Japan	Tsukuba University Hospital	Tsukuba	Ibaraki
Japan	Yokohama Tobu Hospital	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Vascular

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Office Systolic Blood Pressure		Baseline to 6 months post-randomization
Secondary	Incidence of Major Adverse Events (MAE)		Baseline through 1 month post-randomization