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

NCT ID: NCT07115953

Last Updated: 2025-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-22

Study Completion Date

2029-12-31

Brief Summary

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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.

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Detailed Description

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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

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Hypertension Vascular Diseases Cardiovascular Diseases Chronic Kidney Diseases Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SWYFT cohort

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

Group Type EXPERIMENTAL

Symplicity Spyral™ multi-electrode renal denervation system

Intervention Type DEVICE

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

Interventions

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Symplicity Spyral™ multi-electrode renal denervation system

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

Intervention Type DEVICE

Other Intervention Names

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Renal Angiography Renal Denervation

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Individual lacks appropriate renal artery anatomy
2. Individual has undergone prior renal denervation
3. Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement
4. Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
5. Individual has an estimated glomerular filtration rate (eGFR) of \<45 mL/min/1.73m2
6. Individual has one or more episode(s) of orthostatic hypotension
7. Individual is pregnant, nursing or planning to become pregnant
8. Individual has documented primary pulmonary hypertension
9. Individual has documented type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus with glycosylated hemoglobin greater than 8.0%
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Vascular

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Konstantinos Tsioufis, Prof Dr

Role: PRINCIPAL_INVESTIGATOR

Hippokration General Hospital of Athens

Locations

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The Alfred Hospital

Melbourne, , Australia

Site Status RECRUITING

Royal Perth Hospital

Perth, , Australia

Site Status RECRUITING

Ziekenhuis Oost Limburg - Campus Sint-Jan

Genk, Limburg, Belgium

Site Status RECRUITING

Algemeen Stedelijk Ziekenhuis - Campus Aalst

Aalst, , Belgium

Site Status RECRUITING

AZ Sint Jan Brugge-Oostende av

Bruges, , Belgium

Site Status RECRUITING

Universitair Ziekenhuis Gent

Ghent, , Belgium

Site Status RECRUITING

CHC MontLégia

Liège, , Belgium

Site Status RECRUITING

Universitat des Saarlandes

Homburg, Saarland, Germany

Site Status RECRUITING

Sana Kliniken Lübeck GmbH

Lübeck, Schleswig-Holstein, Germany

Site Status RECRUITING

Universitätsklinikum Erlangen

Erlangen, , Germany

Site Status RECRUITING

Leipzig Heart Institute

Leipzig, , Germany

Site Status RECRUITING

Mater Misericordiae University Hospital

Dublin, , Ireland

Site Status ACTIVE_NOT_RECRUITING

Zuyderland Medisch Centrum Heerlen

Heerlen, , Netherlands

Site Status RECRUITING

Erasmus University Medical Center

Rotterdam, , Netherlands

Site Status RECRUITING

Oxford University Hospitals NHS Trust - John Radcliffe Hospital

Oxford, , United Kingdom

Site Status RECRUITING

Countries

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Australia Belgium Germany Ireland Netherlands United Kingdom

Central Contacts

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Kelsey Anderson

Role: CONTACT

[email protected]
651 247 5268

Carly Loudoun, BN, MSc

Role: CONTACT

[email protected]
+31 43 356 6566

Facility Contacts

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Tony Walton, MD

Role: primary

Markus Schlaich, MD

Role: primary

Koen Ameloot, MD

Role: primary

Jan Debrauwere, MD

Role: primary

Jan Van Der Hyden, MD

Role: primary

Benny Drieghe, MD

Role: primary

Pieter-Jan Palmers, MD

Role: primary

Bakuradze Tamara

Role: primary

Joachim Weil, MD

Role: primary

Tolga Agdirlioglu, MD

Role: backup

Roland Schmeider, MD

Role: primary

Karl Fengler, MD

Role: primary

Saman Rasoul, MD

Role: primary

Joost Daemen, MD, PhD

Role: primary

[email protected]
+31 10 70 393 07

Giovanni Luigi De Maria, MD

Role: primary

Other Identifiers

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MDT20044RDN004_SWYFT

Identifier Type: -

Identifier Source: org_study_id

SPYRAL AFFIRM (NCT05198674)

Identifier Type: OTHER

Identifier Source: secondary_id

CIV-21-09-037767

Identifier Type: OTHER

Identifier Source: secondary_id

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