Rapid Renal Sympathetic Denervation for Resistant Hypertension II

Phase 3WithdrawnNCT01939392

Medtronic Endovascular

Overview

This is a global, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation with the OneShot Renal Denervation System in patients with uncontrolled hypertension.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Resistant Hypertension Uncontrolled Hypertension Renal Artery Ablation

Interventions

Renal Denervation (OneShot™ Renal Denervation System)DEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Individual has a systolic blood pressure ≥ 160 mmHg based on an average of three office blood pressure readings. * Stable drug regimen including three or more anti-hypertensive medications including a diuretic Exclusion Criteria: * Renal anatomy unsuitable for treatment * Presence of hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous * Patient has Type I diabetes * Has scheduled or planned surgery within the next 6 months * Individual is pregnant nursing or plans to be pregnant

Locations (1)

Hospital San Raffaele

Milan, Italy

Outcomes

Primary Outcomes

Major adverse event (MAE) rate through 30 days post randomization

Time frame: 30 days

Change in office systolic blood pressure (SBP) from baseline to 6 months post-randomization

Time frame: 6 months

Secondary Outcomes

Acute Procedural Safety

Time frame: 30 days

Chronic procedural safety

Time frame: 6 months

Reduction in SBP by >10 mmHg at 6 months

Time frame: 6 months

Changes in office SBP and diastolic blood pressure (DBP) from baseline to follow-up visits

Time frame: 6, 12, 24, and 36 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.