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

Sponsor
Medtronic Vascular (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05198674
Collaborator
(none)
1,200
Enrollment
2
Locations
1
Arm
67.5
Anticipated Duration (Months)
600
Patients Per Site
8.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Renal Denervation (Symplicity Spyral™)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The SPYRAL AFFIRM Global Clinical Study of Renal Denervation With the Symplicity Spyral Renal Denervation System in Subjects With Uncontrolled Hypertension (SPYRAL AFFIRM)
Actual Study Start Date :
Oct 20, 2021
Anticipated Primary Completion Date :
Jan 22, 2024
Anticipated Study Completion Date :
Jun 7, 2027

Arms and Interventions

ArmIntervention/Treatment
Experimental: Main Cohort: Renal Denervation

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

Device: Renal Denervation (Symplicity Spyral™)
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
  • Outcome Measures

    Primary Outcome Measures

    1. Change in Office Systolic Blood Pressure - Subgroup Chronic Kidney Disease [From baseline to 6 months post-procedure]

      Change in systolic blood pressure from baseline as measured by office blood pressure in subjects with chronic kidney disease.

    2. Office Systolic Blood Pressure change at 6 months - Subgroup Isolated Systolic Hypertension [From baseline to 6 months post-procedure]

      Change in systolic blood pressure from baseline as measured by office blood pressure in subjects with Isolated systolic hypertension

    3. Office Systolic Blood Pressure change at 6 months - Subgroup Diabetes (Type II) [From baseline to 6 months post-procedure]

      Change in systolic blood pressure from baseline as measured by office blood pressure in subjects with Diabetes (Type II)

    Secondary Outcome Measures

    1. Office Systolic Blood Pressure change [From baseline to 3, 6, 12, 24, and 36 months post-procedure]

    2. Home Blood Pressure change (Main Cohort Only) [From baseline to 3, 6, 12, 24, and 36 months post-procedure]

    3. Change in blood pressure as measured by 24-hour ABPM [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 [From Procedure to 3, 6, 12, 24, and 36 months post-procedure]

    5. Time subject's blood pressure is controlled [Procedure to 36 months post-procedure]

    6. Change in number of anti-hypertensive medications taken from baseline [From baseline to 3, 6, 12, 24, and 36 months post-procedure]

    7. Change from baseline in EQ-5D quality of life score [From baseline to 3, 6, 12, 24, and 36 months post-procedure]

    8. Change from baseline in hypertension health status score [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 [From baseline to 3, 6, 12, 24, and 36 months post-procedure]

    10. Percent of subjects requiring repeat renal denervation [From baseline to 3, 6, 12, 24, and 36 months post-procedure]

    11. Incidence of major adverse events [From baseline to 3, 6, 12, 24, and 36 months post-procedure]

    12. Evaluation of slope of eGFR [From baseline to 3, 6, 12, 24, and 36 months post-procedure]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Individual is diagnosed with hypertension and has a baseline office systolic blood pressure ≥140 mmHg
    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 <30

    6. Individual has one or more episode(s) of orthostatic hypotension

    7. Individual is pregnant, nursing or planning to become pregnant

    8. Individual has primary pulmonary hypertension

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Piedmont Heart InstituteAtlantaGeorgiaUnited States30309
    2Universitatsklinikum des SaarlandesHomburgGermany

    Sponsors and Collaborators

    • Medtronic Vascular

    Investigators

    • Principal Investigator: David Kandzari, MD, Piedmont Heart Institute
    • Principal Investigator: Felix Mahfoud, MD, Saarland University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medtronic Vascular
    ClinicalTrials.gov Identifier:
    NCT05198674
    Other Study ID Numbers:
    • MDT20044RDN004
    First Posted:
    Jan 20, 2022
    Last Update Posted:
    Feb 11, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 11, 2022