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

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ClinicalTrials.gov Identifier: NCT05198674
Recruitment Status : Recruiting
First Posted : January 20, 2022
Last Update Posted : May 14, 2024
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular

Study Description
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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 disease Intervention/treatment Phase
Hypertension Vascular Diseases Cardiovascular Diseases Chronic Kidney Diseases Diabetes Mellitus Device: Renal Denervation (Symplicity Spyral™) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1400 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 : October 20, 2021
Estimated Primary Completion Date : November 30, 2026
Estimated Study Completion Date : November 30, 2029

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/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
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Office Systolic Blood Pressure change [ Time Frame: From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure ]
  2. Home Blood Pressure change (Main Cohort Only) [ Time Frame: From baseline to 1, 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 1, 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 1, 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 1, 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 1, 3, 6, 12, 24, and 36 months post-procedure ]
  8. Change from baseline in hypertension health status score [ Time Frame: From baseline to 1, 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 1, 3, 6, 12, 24, and 36 months post-procedure ]
  10. Evaluation of slope of eGFR [ Time Frame: From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure ]
  11. Incidence of events, including major adverse events [ Time Frame: From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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
  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
  9. Individual has documented type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus with glycosylated hemoglobin greater than 8.0%
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05198674


Contacts
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Contact: Kelsey Anderson +17635149730 kelsey.m.anderson@medtronic.com

Locations
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Sponsors and Collaborators
Medtronic Vascular
Investigators
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Principal Investigator: David Kandzari, MD Piedmont Heart Institute
Principal Investigator: Felix Mahfoud, MD Saarland University Hospital
More Information
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Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT05198674    
Other Study ID Numbers: MDT20044RDN004
First Posted: January 20, 2022    Key Record Dates
Last Update Posted: May 14, 2024
Last Verified: May 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Hypertension
Cardiovascular Diseases
Vascular Diseases
Urologic Diseases
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Renal Insufficiency
Chronic Disease
Disease Attributes
Pathologic Processes