Rapid Renal Sympathetic Denervation for Resistant Hypertension Using the OneShot Renal Denervation System II

Medtronic Endovascular1 site in 1 countrySeptember 2013

ConditionsResistant Hypertension Uncontrolled Hypertension Renal Artery Ablation

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Resistant Hypertension
Sponsor: Medtronic Endovascular
Locations: 1
Primary Endpoint: Major adverse event (MAE) rate through 30 days post randomization
Status: Withdrawn
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 2013

End Date

September 2018

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medtronic Endovascular

Responsible Party

Sponsor

Eligibility Criteria

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

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

Reduction in SBP by >10 mmHg at 6 months(6 months)
Changes in office SBP and diastolic blood pressure (DBP) from baseline to follow-up visits(6, 12, 24, and 36 months)
Acute Procedural Safety(30 days)
Chronic procedural safety(6 months)