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

Official title

Sub-study of SPYRAL AFFIRM: Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT)

Overview

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.

Interventions

• Device Symplicity Spyral™ multi-electrode renal denervation system
  After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure.

Primary outcome measures

• Procedure time [Time frame: Procedure]
• Office Systolic Blood Pressure Change [Time frame: 6 months]

Secondary outcome measures (10)

• Office Systolic Blood Pressure change [Time frame: From baseline to 3, 6, 12, 24, and 36 months post-procedure]
• Home Blood Pressure change [Time frame: From baseline to 3, 6, 12, 24, and 36 months post-procedure]
• Change in blood pressure as measured by 24-hour ABPM [Time frame: 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 [Time frame: From baseline to 3, 6, 12, 24, and 36 months post-procedure]
• Time subject's blood pressure is controlled [Time frame: Procedure to 36 months post-procedure]
• Change in number of anti-hypertensive medications taken from baseline [Time frame: From baseline to 3, 6, 12, 24, and 36 months post-procedure]
• Change from baseline in hypertension health status score [Time frame: From baseline to 3, 6, 12, 24, and 36 months post-procedure. A higher score means a better outcome.]
• Evaluate factors influencing blood pressure response to renal denervation [Time frame: From baseline to 3, 6, 12, 24, and 36 months post-procedure]
• Evaluation of slope of eGFR [Time frame: From baseline to 3, 6, 12, 24, and 36 months post-procedure]
• Incidence of safety events, including major adverse events [Time frame: From baseline to 3, 6, 12, 24, and 36 months post-procedure]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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%

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Belgium · 5 centers

• Ziekenhuis Oost Limburg — Genk
• CHC MontLégia — Liège
• Algemeen Stedelijk Ziekenhuis - Campus Aalst — Aalst
• AZ Sint Jan Brugge-Oostende av — Bruges
• Universitair Ziekenhuis Gent — Ghent

Germany · 5 centers

• Universitat des Saarlandes — Homburg
• Sana Kliniken Lübeck GmbH — Lübeck
• Universitätsklinikum Erlangen — Erlangen
• Leipzig Heart Institute — Leipzig
• Schwarzwald-Baar Klinikum Villingen-Schwenningen — Villingen-Schwenningen

Australia · 2 centers

• The Alfred Hospital — Melbourne
• Royal Perth Hospital — Perth

Malaysia · 2 centers

• Sarawak Heart Center — Kota
• Institut Jantung Negara - National Heart Institute — Kuala Lumpur

Netherlands · 2 centers

• Zuyderland Medisch Centrum Heerlen — Heerlen
• Erasmus University Medical Center — Rotterdam

Taiwan · 2 centers

• MacKay Memorial Hospital, Tamsui Branch — Taipei
• National Taiwan University Hospital — Taipei

Greece · 1 center

• Hippokration General Hospital of Athens — Athens

Ireland · 1 center

• Mater Misericordiae University Hospital — Dublin

United Kingdom · 1 center

• Oxford University Hospitals NHS Trust - John Radcliffe Hospital — Oxford

Identifiers

NCT: NCT07115953 · MDT20044RDN004_SWYFT · SPYRAL AFFIRM (NCT05198674) · CIV-21-09-037767

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗