Multi-electrode Radiofrequency Renal Denervation System Feasibility Study

Medtronic

Status: Completed

Conditions: Uncontrolled Hypertension

Treatments: Device: Medtronic Multi-electrode Radiofrequency (RF) Renal Denervation system

Study type: Interventional

Funder types: Industry

Identifiers

NCT01699529

10058715DOC

Details and patient eligibility

About

This is a prospective, single-arm, non-randomized and open label feasibility study. The study is intended to evaluate safety and efficacy of multi-electrode radiofrequency renal denervation in patients with uncontrolled hypertension.

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individual is ≥ 18 and ≤ 80 years old.
• Individual has an office systolic blood pressure of 160 mmHG or greater (≥ 150 mmHg for Type 2 diabetics) based on an average of 3 office/clinic blood pressure readings
• Individual is adhering to a stable medication regimen including ≥ 3 anti-hypertensive medications(preferred that one is a diuretic) for a minimum of two weeks prior to screening.

Exclusion criteria

• Individual has an estimated glomerular filtration rate (eGFR) of < 45 mL/min/1.73 m2
• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Renal Denervation

Experimental group

Treatment:

Device: Medtronic Multi-electrode Radiofrequency (RF) Renal Denervation system