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

Sponsor

Medtronic Vascular (Industry)

Overall Status

Completed

CT.gov ID

NCT01644604

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

2.4

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Uncontrolled Hypertension	Device: MDT-2211 Renal Denervation System	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
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.
No Intervention: Control Group Subjects are maintained on baseline anti-hypertensive medications

Arm

Intervention/Treatment

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.

No Intervention: Control Group

Subjects are maintained on baseline anti-hypertensive medications

Outcome Measures

Primary Outcome Measures

Change in Office Systolic Blood Pressure [Baseline to 6 months post-randomization]

Secondary Outcome Measures

Incidence of Major Adverse Events (MAE) [Baseline through 1 month post-randomization]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Hirosaki University School of Medicine & Hospital	Hirosaki-shi	Aomori	Japan	036-8563
2	Chiba University Hospital	Chiba-shi	Chiba	Japan	260-8677
3	Ehime University Hospital	Toon	Ehime	Japan	791-0295
4	Kyushu University Hospital	Fukuoka-shi	Fukuoka	Japan	812-8582
5	Kurume University Hospital	Kurume-shi	Fukuoka	Japan	830-0011
6	Asahikawa Medical University Hospital	Asahikawa	Hokkaido	Japan	078-8510
7	Sapporo Medical University Hospital	Sapporo-shi	Hokkaido	Japan	060-8543
8	Higashi Takarazuka Satoh Hospital	Takarazuka	Hyogo	Japan	665-0873
9	Tsukuba University Hospital	Tsukuba	Ibaraki	Japan	305-8576
10	Shonan Kamakura General Hospital	Kamakura	Kanagawa	Japan	247-8533
11	Yokohama Tobu Hospital	Yokohama	Kanagawa	Japan	230-0012
12	Kumamoto University Hospital	Kumamoto-shi	Kumamoto	Japan	860-8556
13	Kyoto University Hospital	Sakyo-ku	Kyoto	Japan	606-8507
14	Osaka University Hospital	Suita-shi	Osaka	Japan	565-0871
15	Jichi Medical University Hospital	Shimotsuke	Tochigi	Japan	329-0498
16	Mitsui Memorial Hospital	Chiyoda-ku	Tokyo	Japan	101-8643
17	Tokyo Women's Medical University Hospital	Shinjuku-ku	Tokyo	Japan	162-8666