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

Not Applicable

Active, not recruiting

• Conditions: Hypertension; Chronic Kidney Diseases; Diabetes Mellitus; Vascular Diseases; Cardiovascular Diseases

• Registration Number: NCT05198674
• Lead Sponsor: Medtronic Vascular

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-20
• Study First Submitted: 2021-11-05
• Study First Submitted QC: 2022-01-06
• Study First Posted: 2022-01-20
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-05
• Last Update Posted: 2025-09-12
• Primary Completion: 2026-11-30
• Study Completion: 2029-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1400

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Name	Time	Method
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
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
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
Change from baseline in hypertension health status score	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

Trial Locations

Locations (100)

University of Alabama at Birmingham (UAB) Hospital; 🇺🇸 Birmingham, Alabama, United States

Banner Heart Hospital; 🇺🇸 Mesa, Arizona, United States

Abrazo Arizona Heart Hospital/Biltmore Cardiology; 🇺🇸 Phoenix, Arizona, United States

HonorHealth Research Institute; 🇺🇸 Scottsdale, Arizona, United States

Arkansas Cardiology; 🇺🇸 Little Rock, Arkansas, United States

Scripps Memorial Hospital; 🇺🇸 La Jolla, California, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Stanford Hospital and Clinics; 🇺🇸 Stanford, California, United States

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States

Colorado Heart and Vascular PC; 🇺🇸 Lakewood, Colorado, United States

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