SPYRAL HTN-ON MED Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System
N/A
Completed
NCT02439775
| Condition | Hypertension, Vascular Diseases, Cardiovascular Diseases |
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| Phase | N/A |
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| Sponsor | Medtronic Vascular |
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| Status | Completed |
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| Enrollment | 337 participants |
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| Interventions | Symplicity Spyral™ multi-electrode renal denervation system, Sham Procedure |
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| Start date | Jul 22, 2015 |
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| Completion date | Aug 18, 2022 |
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| Results posted | Sep 15, 2023 |
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Summary
The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the presence of up to three standard antihypertensive medications.
Change in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
From baseline to 6 months post-procedure · mm Hg
| Renal Denervation | -6.5 ± 10.7 mm Hg |
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| Sham Procedure | -4.5 ± 10.3 mm Hg |
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Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events
From Baseline to 1 month post-procedure (6 months for new renal artery stenosis) · Participants
| Renal Denervation | 204 Participants |
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| Sham Procedure | 130 Participants |
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| Renal Denervation | 2 Participants |
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| Sham Procedure | 1 Participants |
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Open in BENITIONS
View on ClinicalTrials.gov
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