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Active, Not Recruiting

NCT Number: NCT05198674

SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN

The purpose of this single-arm interventional study is to evaluate the long-term safety, efficacy, and durability of the Symplicity Spyral system in subjects treated with renal denervation.

Additionally, long-term follow-up data will also be collected from eligible subjects previously treated in the SPYRAL PIVOTAL-SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED studies.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hypertension Cardiovascular Diseases Chronic Disease Chronic Kidney Diseases Diabetes Mellitus Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Alfred Hospital, Melbourne, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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
  • Individual has one or more episode(s) of orthostatic hypotension
  • Individual is pregnant, nursing or planning to become pregnant
  • Individual has primary pulmonary hypertension
  • Individual has documented type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus with glycosylated hemoglobin greater than 8.0%

Treatment and study plan

Renal Denervation (Symplicity Spyral™)

Device

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

Other names: Renal Angiography, Renal Denervation

Primary outcomes

  1. The Primary endpoint of office Systolic Blood Pressure (SBP) change at 6 months.

    Time frame: 6 months

    The Primary endpoint of office Systolic Blood Pressure (SBP) change at 6 months will be assessed for all patients in the Main Study Cohort

Secondary outcomes

  1. Office Systolic Blood Pressure change

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

  2. Home Blood Pressure change (Main Cohort Only)

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

  3. Change in blood pressure as measured by 24-hour ABPM

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

  4. 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

  5. Time subject's blood pressure is controlled

    Time frame: Procedure to 36 months post-procedure

  6. Change in number of anti-hypertensive medications taken from baseline

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

  7. Change from baseline in EQ-5D quality of life score

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

  8. Change from baseline in hypertension health status score

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

  9. Evaluate pre-specified subgroups (Chronic Kidney Disease, Diabetes Mellitus Type II, etc) as predictors for change in blood pressure as measured by OBP, HBP and ABPM

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

  10. Evaluation of slope of eGFR

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

  11. Incidence of events, including major adverse events

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

Sponsors and collaborators

Lead sponsor

Medtronic Vascular

Industry

Registry information

Official study title

The SPYRAL AFFIRM Global Clinical Study of Renal Denervation With the Symplicity Spyral Renal Denervation System in Subjects With Uncontrolled Hypertension (SPYRAL AFFIRM)

Important dates

Study start
2021
Primary completion
2026
Study completion
2029
First posted
Jan 20, 2022
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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