Rapid Renal Sympathetic Denervation for Resistant Hypertension II

Phase 2

Withdrawn

• Conditions: Renal Artery Ablation; Resistant Hypertension; Uncontrolled Hypertension
• Interventions: Device: Renal Denervation (OneShot™ Renal Denervation System)

• Registration Number: NCT01939392
• Lead Sponsor: Medtronic Endovascular

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-06
• Study First Submitted QC: 2013-09-06
• Study First Posted: 2013-09-11
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-14
• Last Update Posted: 2015-08-18
• Primary Completion: 2015-09
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Renal Denervation	Renal Denervation (OneShot™ Renal Denervation System)	Subjects randomized to the Renal Denervation arm will receive bilateral renal ablation with the OneShot system and be maintained on antihypertensive medication.

Primary Outcome Measures

Name	Time	Method
Major adverse event (MAE) rate through 30 days post randomization	30 days
Change in office systolic blood pressure (SBP) from baseline to 6 months post-randomization	6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital San Raffaele; 🇮🇹 Milano, Italy