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

June 29, 2012
April 10, 2014
July 2012
June 2015   (final data collection date for primary outcome measure)
Change in Office Systolic Blood Pressure [ Time Frame: Baseline to 6 months post-randomization ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01644604 on ClinicalTrials.gov Archive Site
Incidence of Major Adverse Events (MAE) [ Time Frame: Baseline through 1 month post-randomization ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Renal Denervation by MDT-2211 System in Patients With Uncontrolled Hypertension
The Clinical Study of Renal Denervation by MDT-2211 System in Patients With Uncontrolled Hypertension

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Uncontrolled Hypertension
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
  • Experimental: Renal denervation
    Subjects are treated with the renal denervation procedure after randomization and are maintained on baseline anti-hypertensive medications.
    Intervention: Device: MDT-2211 Renal Denervation System
  • No Intervention: Control Group
    Subjects are maintained on baseline anti-hypertensive medications
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
March 2018
June 2015   (final data collection date for primary outcome measure)

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.
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01644604
MDT2-11-07
Yes
Medtronic Vascular
Medtronic Vascular
Not Provided
Principal Investigator: Kazuyuki Shimada, MD New Oyama Municipal Hospital
Medtronic Vascular
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP