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

Purpose

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.

Conditions

  • Hypertension
  • Vascular Diseases
  • Cardiovascular Diseases
  • Chronic Kidney Diseases
  • Diabetes Mellitus

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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%

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama 35233
Contact:
Alisha Hitt, RN
205-539-2908
aghitt@uabmc.edu

More Details

Status
Recruiting
Sponsor
Medtronic Vascular

Study Contact

Kelsey Anderson
+17635149730
kelsey.m.anderson@medtronic.com