Renal Denervation by MDT-2211 System in Patients With Uncontrolled Hypertension (HTN-J)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT01644604
First received: June 29, 2012
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Uncontrolled Hypertension
Device: MDT-2211 Renal Denervation System
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Clinical Study of Renal Denervation by MDT-2211 System in Patients With Uncontrolled Hypertension

Resource links provided by NLM:


Further study details as provided by Medtronic Vascular:

Primary Outcome Measures:
  • Change in Office Systolic Blood Pressure [ Time Frame: Baseline to 6 months post-randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of Major Adverse Events (MAE) [ Time Frame: Baseline through 1 month post-randomization ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: July 2012
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Renal denervation
Subjects are treated with the renal denervation procedure after randomization and are maintained on baseline anti-hypertensive medications.
Device: MDT-2211 Renal Denervation System
A percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery.
Other Name: MDT-2211 Renal Denervation System
No Intervention: Control Group
Subjects are maintained on baseline anti-hypertensive medications

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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01644604

Locations
Japan
Hirosaki University School of Medicine & Hospital
Hirosaki-shi, Aomori, Japan, 036-8563
Chiba University Hospital
Chiba-shi, Chiba, Japan, 260-8677
Ehime University Hospital
Toon, Ehime, Japan, 791-0295
Kyushu University Hospital
Fukuoka-shi, Fukuoka, Japan, 812-8582
Kurume University Hospital
Kurume-shi, Fukuoka, Japan, 830-0011
Asahikawa Medical University Hospital
Asahikawa, Hokkaido, Japan, 078-8510
Sapporo Medical University Hospital
Sapporo-shi, Hokkaido, Japan, 060-8543
Higashi Takarazuka Satoh Hospital
Takarazuka, Hyogo, Japan, 665-0873
Tsukuba University Hospital
Tsukuba, Ibaraki, Japan, 305-8576
Shonan Kamakura General Hospital
Kamakura, Kanagawa, Japan, 247-8533
Yokohama Tobu Hospital
Yokohama, Kanagawa, Japan, 230-0012
Kumamoto University Hospital
Kumamoto-shi, Kumamoto, Japan, 860-8556
Kyoto University Hospital
Sakyo-ku, Kyoto, Japan, 606-8507
Osaka University Hospital
Suita-shi, Osaka, Japan, 565-0871
Jichi Medical University Hospital
Shimotsuke, Tochigi, Japan, 329-0498
Mitsui Memorial Hospital
Chiyoda-ku, Tokyo, Japan, 101-8643
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, Japan, 162-8666
Sponsors and Collaborators
Medtronic Vascular
Investigators
Principal Investigator: Kazuyuki Shimada, MD New Oyama Municipal Hospital
  More Information

No publications provided

Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT01644604     History of Changes
Other Study ID Numbers: MDT2-11-07
Study First Received: June 29, 2012
Last Updated: April 10, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Medtronic Vascular:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Renal denervation

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014