Diabetes Mellitus, Heart Failure, Hypertension, Sleep Apnea
Conditions
Brief summary
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.
Interventions
DEVICEOneShot Ablation System
Renal denervation
Sponsors
Medtronic Endovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in office systolic blood pressure (SBP) from baseline to 6 months | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Acute procedural safety, defined as freedom from renal artery dissection or perforation requiring intervention. | One Week |
| Change in office diastolic blood pressure (DBP) | 6 and 12 months post procedure |
| Change in office SBP | 6 and 12 months post procedure |
Countries
Italy
Outcome results
None listed