Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)

Medtronic

Status: Completed

Conditions: Uncontrolled Hypertension

Treatments: Device: Renal Denervation (Symplicity® Renal Denervation System)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00888433

TP-058

Details and patient eligibility

About

An international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation in patients with uncontrolled hypertension.

Enrollment: 106 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• systolic blood pressure >=160mmHg (>=150 mmHg for type 2 diabetics);
• on 3 or more antihypertensive medications
• >= 18 and =< 85 years of age.

Exclusion criteria

• renal artery abnormalities
• eGFR < 45mL/min
• MI, angina, CVA within 6 months
• Type 1 diabetes
• ICD or pacemaker, or any other metallic implant not compatible with MRI
• others

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

106 participants in 2 patient groups

Renal Denervation

Experimental group

Description:

Renal Denervation and maintenance of anti-hypertensive medications

Treatment:

Device: Renal Denervation (Symplicity® Renal Denervation System)

Control

No Intervention group

Description:

Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months