NCT07115953

Brief 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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
45mo left

Started Sep 2025

Longer than P75 for not_applicable hypertension

Geographic Reach
8 countries

19 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Sep 2025Dec 2029

First Submitted

Initial submission to the registry

July 24, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

September 22, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

April 9, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

July 24, 2025

Last Update Submit

April 6, 2026

Conditions

HypertensionVascular DiseasesCardiovascular DiseasesChronic Kidney DiseasesDiabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • Procedure time

    Procedure time will be compared to the SPYRAL HTN-ON MED and SPYRAL PIVOTAL - SPYRAL HTN-OFF MED procedure times.

    Procedure

  • Office Systolic Blood Pressure Change

    Office Systolic Blood Pressure (OSBP) change from baseline to 6 months will be compared to the SPYRAL HTN-ON MED and SPYRAL PIVOTAL - SPYRAL HTN-OFF MED study efficacy endpoints using a propensity score stratified baseline blood pressure adjusted analysis at 3 months (OFF MED) and 6 months (ON MED).

    6 months

Secondary Outcomes (10)

  • Office Systolic Blood Pressure change

    From baseline to 3, 6, 12, 24, and 36 months post-procedure

  • Home Blood Pressure change

    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 baseline to 3, 6, 12, 24, and 36 months post-procedure

  • Time subject's blood pressure is controlled

    Procedure to 36 months post-procedure

  • +5 more secondary outcomes

Study Arms (1)

SWYFT cohort

EXPERIMENTAL

Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)

Device: Symplicity Spyral™ multi-electrode renal denervation system

Interventions

Symplicity Spyral™ multi-electrode renal denervation systemDEVICE

After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure.

Also known as: Renal Angiography, Renal Denervation
SWYFT cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individual is diagnosed with hypertension and has a baseline office systolic blood pressure ≥140 mmHg
  • Individual has a baseline office diastolic blood pressure ≥ 90 mmHg
  • Individual has an average systolic baseline home blood pressure ≥135 mmHg (with ≥7 days of valid pre-procedure measurements)
  • Individual has a valid 24-hour Ambulatory Blood Pressure Measurement at baseline

You may not qualify if:

  • Individual lacks appropriate renal artery anatomy
  • Individual has undergone prior renal denervation
  • Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement
  • 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 \<45 mL/min/1.73m2
  • Individual has one or more episode(s) of orthostatic hypotension
  • Individual is pregnant, nursing or planning to become pregnant
  • Individual has documented primary pulmonary hypertension
  • Individual has documented type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus with glycosylated hemoglobin greater than 8.0%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

The Alfred Hospital

Melbourne, Australia

RECRUITING

Royal Perth Hospital

Perth, Australia

RECRUITING

Ziekenhuis Oost Limburg - Campus Sint-Jan

Genk, Limburg, 3600, Belgium

RECRUITING

CHC MontLégia

Liège, Liège, 4000, Belgium

RECRUITING

Algemeen Stedelijk Ziekenhuis - Campus Aalst

Aalst, Belgium

RECRUITING

AZ Sint Jan Brugge-Oostende av

Bruges, 8000, Belgium

RECRUITING

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

RECRUITING

Universitat des Saarlandes

Homburg, Saarland, 66123, Germany

RECRUITING

Sana Kliniken Lübeck GmbH

Lübeck, Schleswig-Holstein, 23560, Germany

RECRUITING

Universitätsklinikum Erlangen

Erlangen, Germany

RECRUITING

Leipzig Heart Institute

Leipzig, Germany

RECRUITING

Schwarzwald-Baar Klinikum Villingen-Schwenningen

Villingen-Schwenningen, Germany

RECRUITING

Mater Misericordiae University Hospital

Dublin, Dublin, D07 R2WY, Ireland

TERMINATED

Sarawak Heart Center

Kota, Malaysia

RECRUITING

Zuyderland Medisch Centrum Heerlen

Heerlen, 6419 PC, Netherlands

RECRUITING

Erasmus University Medical Center

Rotterdam, Netherlands

RECRUITING

MacKay Memorial Hospital, Tamsui Branch

Taipei, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Oxford University Hospitals NHS Trust - John Radcliffe Hospital

Oxford, United Kingdom

RECRUITING

MeSH Terms

Conditions

HypertensionVascular DiseasesCardiovascular DiseasesRenal Insufficiency, ChronicDiabetes Mellitus

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • David Lee, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

  • Konstantinos Tsioufis, Prof Dr

    Hippokration General Hospital of Athens

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelsey Anderson

CONTACT

651 247 5268rs.spyralaffirm@medtronic.com

Carly Loudoun, BN, MSc

CONTACT

+31 43 356 6566rs.spyralaffirm@medtronic.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2025

First Posted

August 11, 2025

Study Start

September 22, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2029

Last Updated

April 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual participant data. Aggregate results will be made publicly available via publications and conference presentations.

Locations

MY(1)DE(5)NL(2)IE(1)BE(5)AU(2)TW(2)GB(1)