Trials / Recruiting
RecruitingNCT07115953
Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension
Sub-study of SPYRAL AFFIRM: Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- Sponsor
- Medtronic Vascular · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the SPYRAL SWYFT sub-study is to evaluate whether renal denervation with the Symplicity Spyral system performed in the main and first order branch renal arteries yields a shorter procedure time and is as effective in reducing blood pressure than the procedural approach used in the SPYRAL HTN-ON MED and SPYRAL PIVOTAL - SPYRAL HTN-OFF MED clinical studies in an uncontrolled hypertensive population.
Detailed description
SPYRAL SWYFT will evaluate the long-term safety, efficacy, and durability of the Symplicity Spyral system to determine whether renal denervation performed in the main and first order branch renal arteries yields a shorter procedure time and is as effective in reducing blood pressure than the procedural approach used in the SPYRAL HTN-ON MED and SPYRAL PIVOTAL - SPYRAL HTN-OFF MED clinical studies (where all accessible renal arterial vessels between 3 and 8 mm in diameter including accessory, branch and main renal arteries (outside the kidney parenchyma) were targeted for ablation). SPYRAL SWYFT study is conducted under the overarching SPYRAL AFFIRM protocol (NCT05198674), focused on EU and APAC regions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Symplicity Spyral™ multi-electrode renal denervation system | After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure. |
Timeline
- Start date
- 2025-09-22
- Primary completion
- 2027-06-30
- Completion
- 2029-12-31
- First posted
- 2025-08-11
- Last updated
- 2026-04-09
Locations
19 sites across 8 countries: Australia, Belgium, Germany, Ireland, Malaysia, Netherlands, Taiwan, United Kingdom
Source: ClinicalTrials.gov record NCT07115953. Inclusion in this directory is not an endorsement.