SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN

Study Overview
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Brief Summary
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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.

Official Title
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The SPYRAL AFFIRM Global Clinical Study of Renal Denervation With the Symplicity Spyral Renal Denervation System in Subjects With Uncontrolled Hypertension (SPYRAL AFFIRM)

Conditions
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Hypertension, Vascular Diseases, Cardiovascular Diseases, Chronic Kidney Diseases, Diabetes Mellitus

Intervention / Treatment
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* Device: Renal Denervation (Symplicity Spyral™)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Individual is diagnosed with hypertension and has a baseline office systolic blood pressure ≥140 mmHg Exclusion Criteria: Individual lacks appropriate renal artery anatomy Individual has undergone prior renal denervation Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea Individual has an estimated glomerular filtration rate (eGFR) of <30 Individual has one or more episode(s) of orthostatic hypotension Individual is pregnant, nursing or planning to become pregnant Individual has primary pulmonary hypertension

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Main Cohort: Renal Denervation<br>Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) | Device: Renal Denervation (Symplicity Spyral™)<br>* Device: Symplicity Spyral™ multi-electrode renal denervation system. After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure.<br>* Other names: Renal Denervation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Office Systolic Blood Pressure - Subgroup Chronic Kidney Disease | Change in systolic blood pressure from baseline as measured by office blood pressure in subjects with chronic kidney disease. | From baseline to 6 months post-procedure | 
| Office Systolic Blood Pressure change at 6 months - Subgroup Isolated Systolic Hypertension | Change in systolic blood pressure from baseline as measured by office blood pressure in subjects with Isolated systolic hypertension | From baseline to 6 months post-procedure | 
| Office Systolic Blood Pressure change at 6 months - Subgroup Diabetes (Type II) | Change in systolic blood pressure from baseline as measured by office blood pressure in subjects with Diabetes (Type II) | From baseline to 6 months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 Procedure 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 | 
| Percent of subjects requiring repeat renal denervation |  | From baseline to 3, 6, 12, 24, and 36 months post-procedure | 
| Incidence of major adverse events |  | 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 |