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

N/AActive Not RecruitingNCT05198674

Medtronic Vascular1,300 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

1,300

Conditions

Hypertension Vascular Diseases Cardiovascular Diseases Chronic Kidney Diseases Diabetes Mellitus

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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%

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

Outcomes

Primary Outcomes

The Primary endpoint of office Systolic Blood Pressure (SBP) change at 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

Time frame: 6 months