NCT01644604

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Medtronic Vascular · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Uncontrolled Hypertension

Interventions

Type	Name	Description
DEVICE	MDT-2211 Renal Denervation System	A percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery.

Timeline

• Start date: 2012-07-01
• Primary completion: 2015-04-01
• Completion: 2017-06-01
• First posted: 2012-07-19
• Last updated: 2017-07-02

Locations

17 sites across 1 country: Japan