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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: October 3, 2014
Last verified: October 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: October 3, 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
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014