Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT05198674
NCT05198674Active, not recruitingNot Applicable

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

Medtronic Vascular101 sites in 3 countries1,899 target enrollmentStarted: October 20, 2021Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
1,899
Locations
101
Primary Endpoint
The Primary endpoint of office Systolic Blood Pressure (SBP) change at 6 months.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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%

Arms & Interventions

Main Cohort: Renal Denervation

Experimental

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

Intervention: Renal Denervation (Symplicity Spyral™) (Device)

Outcomes

Primary Outcomes

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

  • Percent of subjects achieving blood pressure control as measured by OBP, HBP and ABPM(From baseline to 3, 6, 12, 24, and 36 months post-procedure)
  • Time subject's blood pressure is controlled(Procedure to 36 months post-procedure)
  • Change in number of anti-hypertensive medications taken from baseline(From baseline to 3, 6, 12, 24, and 36 months post-procedure)
  • Change from baseline in EQ-5D quality of life score(From baseline to 3, 6, 12, 24, and 36 months post-procedure)
  • Change from baseline in hypertension health status score(From baseline to 3, 6, 12, 24, and 36 months post-procedure)
  • 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)
  • Evaluation of slope of eGFR(From baseline to 3, 6, 12, 24, and 36 months post-procedure)
  • Incidence of events, including major adverse events(From baseline to 3, 6, 12, 24, and 36 months post-procedure)
  • Office Systolic Blood Pressure change(From baseline to 3, 6, 12, 24, and 36 months post-procedure)
  • Home Blood Pressure change (Main Cohort Only)(From baseline to 3, 6, 12, 24, and 36 months post-procedure)
  • Change in blood pressure as measured by 24-hour ABPM(From baseline to 3, 6, 12, 24, and 36 months post-procedure)

Investigators

Sponsor
Medtronic Vascular
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (101)

Loading locations...

Similar Trials

Recruiting
Not Applicable
The SPYRAL AFFIRM Global Clinical Study of Renal Denervation with the Symplicity Spyral Renal Denervation System in Subjects with Uncontrolled Hypertension (SPYRAL AFFIRM)uncontrolled hypertension10057166
NL-OMON51861Medtronic B.V.20
Completed
Not Applicable
SPYRAL DYSTAL Renal Denervation Global Clinical StudyVascular DiseasesCardiovascular DiseasesHypertension
NCT04311086Medtronic Vascular128
Completed
Phase 3
Efficacy, Safety and Tolerability of Everolimus in Combination With Reduced Exposure Cyclosporine or Tacrolimus in Paediatric Liver Transplant Recipients.Renal FunctionLiver Transplant
NCT01598987Novartis Pharmaceuticals56
Enrolling By Invitation
Phase 2
the Prevention of Bone Marrow Suppression Caused by Chemotherapy in Advanced NSCLC With TrilaciclibNon-small Cell Lung Cancer
NCT06370416Henan Cancer Hospital41
Completed
Phase 2
A Study Investigating the Long-term Safety and Efficacy of Deferiprone in Patients With Friedreich's AtaxiaFriedreich's Ataxia
NCT00897221ApoPharma36