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

Medtronic

Status: Enrolling

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

Treatments: Device: Renal Denervation (Symplicity Spyral™)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05198674

MDT20044RDN004

Details and patient eligibility

About

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.

Enrollment: 1,400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,400 participants in 1 patient group

Main Cohort: Renal Denervation

Experimental group

Description:

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

Treatment:

Device: Renal Denervation (Symplicity Spyral™)