NCT02439775

SPYRAL HTN-ON MED Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System

Global Clinical Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension on Standard Medical Therapy (SPYRAL HTN-ON MED)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 337 (actual)
• Sponsor: Medtronic Vascular · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of this study is to test the hypothesis that renal denervation is safe and reduces systolic blood pressure (SBP) in patients with uncontrolled hypertension on one, two, or three standard antihypertensive medications compared to a sham control in the same population. In this study, "uncontrolled hypertension" is defined as an office systolic blood pressure (SBP) ≥ 150 mmHg and \<180 mmHg, an office Diastolic Blood Pressure (DBP) ≥90 mmHg and a 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP ≥140 mmHg to \<170 mmHg, all of which are measured at Screening Visits. Data obtained will be used to confirm the effect of renal denervation on elevated blood pressure in patients on 1, 2 or 3 antihypertensive medications.

Conditions

• Hypertension
• Vascular Diseases
• Cardiovascular Diseases

Interventions

Type	Name	Description
DEVICE	Symplicity Spyral™ multi-electrode renal denervation system	After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
PROCEDURE	Sham Procedure	After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Timeline

• Start date: 2015-07-22
• Primary completion: 2022-08-18
• Completion: 2025-08-14
• First posted: 2015-05-12
• Last updated: 2025-11-14
• Results posted: 2023-09-15

Locations

56 sites across 10 countries: United States, Australia, Austria, Canada, France, Germany, Greece, Ireland, Japan, United Kingdom

Regulatory

• FDA-regulated device study