Symplicity Spyral™ multi-electrode renal denervation system

DEVICE3 trials

Sponsors

Medtronic Vascular

Conditions

Cardiovascular DiseasesChronic Kidney DiseasesDiabetes MellitusHypertensionVascular Diseases

Unknown Phase

SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study

CompletedNCT02439749

Medtronic VascularCardiovascular Diseases, Hypertension, Vascular Diseases

Start: 2015-06-30End: 2023-10-25Updated: 2025-03-28

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

CompletedNCT02439775

Medtronic VascularCardiovascular Diseases, Hypertension, Vascular Diseases

Start: 2015-07-22End: 2025-08-14Updated: 2026-07-30

Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension

RecruitingNCT07115953

Medtronic VascularCardiovascular Diseases, Chronic Kidney Diseases, Diabetes Mellitus +2

Start: 2025-09-22End: 2029-12-31Target: 130Updated: 2026-06-30

Related Papers

Three‐Year Durability of Radiofrequency Renal Denervation: SPYRAL HTN‐ON MED

Journal of the American Heart Association2026-06-15

Long-Term Safety and Efficacy of Renal Denervation: 24-Month Results From the SPYRAL HTN-ON MED Trial

Circulation Cardiovascular Interventions2025-05-206 citations

Impact of Antihypertensive Medication Changes After Renal Denervation Among Different Patient Groups: SPYRAL HTN-ON MED

Hypertension2024-02-0528 citations

Safety and Efficacy of Renal Denervation in Patients Taking Antihypertensive Medications.

2023-11-0180 citations

Hypertension urgencies in the SPYRAL HTN-OFF MED Pivotal trial.

2022-07-197 citations

Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial.

2022-04-04200 citations

Effect of Heart Rate on the Outcome of Renal Denervation in Patients With Uncontrolled Hypertension.

2021-09-0138 citations

Changes in Plasma Renin Activity After Renal Artery Sympathetic Denervation

Journal of the American College of Cardiology2021-05-03104 citations

Prioritised endpoints for device-based hypertension trials: the win ratio methodology

EuroIntervention2021-04-0119 citations

Effect of renal denervation in attenuating the stress of morning surge in blood pressure: post-hoc analysis from the SPYRAL HTN-ON MED trial.

2020-08-0118 citations

Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial.

2020-03-29405 citations

Rationale and design of two randomized sham-controlled trials of catheter-based renal denervation in subjects with uncontrolled hypertension in the absence (SPYRAL HTN-OFF MED Pivotal) and presence (SPYRAL HTN-ON MED Expansion) of antihypertensive medications: a novel approach using Bayesian design.

2020-02-0728 citations

Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial.

2018-05-23517 citations

Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFF MED): a randomised, sham-controlled, proof-of-concept trial.

2017-08-28496 citations