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

Description

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

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Study Overview

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Study Details

Study 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.

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

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

Condition
Hypertension
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham (UAB) Hospital, Birmingham, Alabama, United States, 35233

Mesa

Banner Heart Hospital, Mesa, Arizona, United States, 85206

Phoenix

Abrazo Arizona Heart Hospital/Biltmore Cardiology, Phoenix, Arizona, United States, 85016

Scottsdale

HonorHealth Research Institute, Scottsdale, Arizona, United States, 85258

Little Rock

Arkansas Cardiology, Little Rock, Arkansas, United States, 72205

La Jolla

Scripps Memorial Hospital, La Jolla, California, United States, 92037

Stanford

Stanford Hospital and Clinics, Stanford, California, United States, 94305

Aurora

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States, 80045

Lakewood

Colorado Heart and Vascular PC, Lakewood, Colorado, United States, 80228

Hartford

Hartford Hospital, Hartford, Connecticut, United States, 06102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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%

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medtronic Vascular,

David Kandzari, MD, PRINCIPAL_INVESTIGATOR, Piedmont Heart Institute

Felix Mahfoud, MD, PRINCIPAL_INVESTIGATOR, Saarland University Hospital

Study Record Dates

2029-11-30