SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Main Cohort: Renal Denervation Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) |
Device: Renal Denervation (Symplicity Spyral™)
Device: Symplicity Spyral™ multi-electrode renal denervation system. After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Change in Office Systolic Blood Pressure - Subgroup Chronic Kidney Disease [From baseline to 6 months post-procedure]
Change in systolic blood pressure from baseline as measured by office blood pressure in subjects with chronic kidney disease.
- Office Systolic Blood Pressure change at 6 months - Subgroup Isolated Systolic Hypertension [From baseline to 6 months post-procedure]
Change in systolic blood pressure from baseline as measured by office blood pressure in subjects with Isolated systolic hypertension
- Office Systolic Blood Pressure change at 6 months - Subgroup Diabetes (Type II) [From baseline to 6 months post-procedure]
Change in systolic blood pressure from baseline as measured by office blood pressure in subjects with Diabetes (Type II)
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Individual is diagnosed with hypertension and has a baseline office systolic blood pressure ≥140 mmHg
Exclusion Criteria:
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Individual lacks appropriate renal artery anatomy
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Individual has undergone prior renal denervation
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Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement
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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
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Individual has one or more episode(s) of orthostatic hypotension
-
Individual is pregnant, nursing or planning to become pregnant
-
Individual has primary pulmonary hypertension
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Piedmont Heart Institute | Atlanta | Georgia | United States | 30309 |
| 2 | Baylor Scott & White The Heart Hospital Baylor Plano | Plano | Texas | United States | 75093 |
| 3 | Universitatsklinikum des Saarlandes | Homburg | Germany |
Sponsors and Collaborators
- Medtronic Vascular
Investigators
- Principal Investigator: David Kandzari, MD, Piedmont Heart Institute
- Principal Investigator: Felix Mahfoud, MD, Saarland University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MDT20044RDN004