Cardiovascular Diseases, Chronic Kidney Diseases, Diabetes Mellitus, Hypertension, Vascular Diseases
Conditions
Brief summary
The purpose of this single-arm interventional study is to evaluate the long-term safety, efficacy, and durability of the Symplicity Spyral system in subjects treated with renal denervation. Additionally, long-term follow-up data will also be collected from eligible subjects previously treated in the SPYRAL PIVOTAL-SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED studies.
Interventions
Device: Symplicity Spyral™ multi-electrode renal denervation system. After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure.
Sponsors
Medtronic Vascular
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
1. Individual is diagnosed with hypertension and has a baseline office systolic blood pressure ≥140 mmHg 2. Individual has a baseline office diastolic blood pressure ≥ 90 mmHg 3. Individual has an average systolic baseline home blood pressure ≥135 mmHg
Exclusion criteria
1. Individual lacks appropriate renal artery anatomy 2. Individual has undergone prior renal denervation 3. Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement 4. Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea 5. Individual has an estimated glomerular filtration rate (eGFR) of \<45 6. Individual has one or more episode(s) of orthostatic hypotension 7. Individual is pregnant, nursing or planning to become pregnant 8. Individual has primary pulmonary hypertension 9. Individual has documented type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus with glycosylated hemoglobin greater than 8.0%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary endpoint of office Systolic Blood Pressure (SBP) change at 6 months. | 6 months | The Primary endpoint of office Systolic Blood Pressure (SBP) change at 6 months will be assessed for all patients in the Main Study Cohort |
Secondary
| Measure | Time frame |
|---|---|
| Office Systolic Blood Pressure change | From baseline to 3, 6, 12, 24, and 36 months post-procedure |
| Home Blood Pressure change (Main Cohort Only) | From baseline to 3, 6, 12, 24, and 36 months post-procedure |
| Change in blood pressure as measured by 24-hour ABPM | From baseline to 3, 6, 12, 24, and 36 months post-procedure |
| Percent of subjects achieving blood pressure control as measured by OBP, HBP and ABPM | From baseline to 3, 6, 12, 24, and 36 months post-procedure |
| Time subject's blood pressure is controlled | Procedure to 36 months post-procedure |
| Change in number of anti-hypertensive medications taken from baseline | From baseline to 3, 6, 12, 24, and 36 months post-procedure |
| Change from baseline in EQ-5D quality of life score | From baseline to 3, 6, 12, 24, and 36 months post-procedure |
| Change from baseline in hypertension health status score | From baseline to 3, 6, 12, 24, and 36 months post-procedure |
| Evaluate pre-specified subgroups (Chronic Kidney Disease, Diabetes Mellitus Type II, etc) as predictors for change in blood pressure as measured by OBP, HBP and ABPM | From baseline to 3, 6, 12, 24, and 36 months post-procedure |
| Evaluation of slope of eGFR | From baseline to 3, 6, 12, 24, and 36 months post-procedure |
| Incidence of events, including major adverse events | From baseline to 3, 6, 12, 24, and 36 months post-procedure |
Countries
Australia, Belgium, France, Germany, Greece, Ireland, Monaco, Netherlands, Sweden, United Kingdom, United States
Contacts
PRINCIPAL_INVESTIGATORDavid Kandzari, MD
Piedmont Heart Institute
PRINCIPAL_INVESTIGATORFelix Mahfoud, MD
Saarland University Hospital
Outcome results
None listed