OneShot Renal Denervation Registry

Phase 3TerminatedNCT01844037

Medtronic Endovascular51 enrolled

Overview

This is a multi-center, prospective registry designed to monitor the outcomes of renal denervation with the OneShot Device in a real-world patient population.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension Heart Failure Diabetes Mellitus Sleep Apnea

Interventions

OneShot Ablation SystemDEVICE

Renal denervation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient is an acceptable candidate for renal denervation based upon the Instructions for Use. * Patient is ≥ 18 years old. * Patient provided written informed consent. Exclusion Criteria: * Patients who are pregnant, nursing, or planning to become pregnant. * Patients who have only one functioning kidney. * Allergy to contrast or known hypersensitivity to device materials * Patients with renal arteries \< 4 mm in diameter. * Patients whose life expectancy is less than the planned period of study involvement.

Locations (1)

Hospital San Raffaele

Milan, Italy

Outcomes

Primary Outcomes

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

Time frame: 6 months

Secondary Outcomes

Acute procedural safety, defined as freedom from renal artery dissection or perforation requiring intervention.

Time frame: One Week

Change in office diastolic blood pressure (DBP)

Time frame: 6 and 12 months post procedure

Change in office SBP

Time frame: 6 and 12 months post procedure

Data from ClinicalTrials.gov

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