ACTIVE_NOT_RECRUITING

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

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Conditions

HypertensionVascular DiseasesCardiovascular DiseasesChronic Kidney DiseasesDiabetes Mellitus

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-10-20
Study Completion:2029-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05198674

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Individual is diagnosed with hypertension and has a baseline office systolic blood pressure ≥140 mmHg
  2. 2. Individual has a baseline office diastolic blood pressure ≥ 90 mmHg
  3. 3. Individual has an average systolic baseline home blood pressure ≥135 mmHg
  1. 1. Individual lacks appropriate renal artery anatomy
  2. 2. Individual has undergone prior renal denervation
  3. 3. Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement
  4. 4. Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
  5. 5. Individual has an estimated glomerular filtration rate (eGFR) of \<45
  6. 6. Individual has one or more episode(s) of orthostatic hypotension
  7. 7. Individual is pregnant, nursing or planning to become pregnant
  8. 8. Individual has primary pulmonary hypertension
  9. 9. Individual has documented type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus with glycosylated hemoglobin greater than 8.0%

Contacts and Locations

Principal Investigator

David Kandzari, MD
PRINCIPAL_INVESTIGATOR
Piedmont Heart Institute
Felix Mahfoud, MD
PRINCIPAL_INVESTIGATOR
Saarland University Hospital

Study Locations (Sites)

University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama, 35233
United States
Banner Heart Hospital
Mesa, Arizona, 85206
United States
Abrazo Arizona Heart Hospital/Biltmore Cardiology
Phoenix, Arizona, 85016
United States
HonorHealth Research Institute
Scottsdale, Arizona, 85258
United States
Arkansas Cardiology
Little Rock, Arkansas, 72205
United States
Scripps Memorial Hospital
La Jolla, California, 92037
United States
University of California, San Francisco
San Francisco, California, 94143
United States
Stanford Hospital and Clinics
Stanford, California, 94305
United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
United States
Colorado Heart and Vascular PC
Lakewood, Colorado, 80228
United States
Hartford Hospital
Hartford, Connecticut, 06102
United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
United States
BayCare Health System
Clearwater, Florida, 33756
United States
Clearwater Cardiovascular Consultants
Clearwater, Florida, 33756
United States
Baptist Medical Center
Jacksonville, Florida, 32207
United States
University of Miami Hosptial
Miami, Florida, 33136
United States
AdventHealth Orlando
Orlando, Florida, 32803
United States
Orlando Health Heart & Vascular Institute
Orlando, Florida, 32806
United States
BayCare Medical Group
Safety Harbor, Florida, 34695
United States
Tallahassee Memorial Healthcare, Inc
Tallahassee, Florida, 32308
United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308
United States
Piedmont Heart Institute
Atlanta, Georgia, 30309
United States
Wellstar Research Institute
Marietta, Georgia, 30060
United States
University of Chicago Medicine
Chicago, Illinois, 60637
United States
Loyola University Medical Center
Maywood, Illinois, 60153-3328
United States
Heart Care Centers of Illinois
Palos Park, Illinois, 60464
United States
St. Vincents Hospital
Indianapolis, Indiana, 46290
United States
Mercy Medical Center
West Des Moines, Iowa, 50266-8209
United States
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States
Saint Joseph Medical Center (Towson MD)
Towson, Maryland, 21204
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Henry Ford Saint John Hospital
Detroit, Michigan, 48236
United States
Spectrum Health Hospitals
Grand Rapids, Michigan, 49503-2560
United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341
United States
Henry Ford Providence Southfield Hospital
Southfield, Michigan, 48075
United States
Metropolitan Heart and Vascular Institute (MHVI)
Coon Rapids, Minnesota, 55433
United States
CentraCare Heart & Vascular Center
Saint Cloud, Minnesota, 56303-1900
United States
North Mississippi Medical Center
Tupelo, Mississippi, 38801
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68105
United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
United States
Dartmouth-Hitchcock
Lebanon, New Hampshire, 03756
United States
Virtua Medical Group
Marlton, New Jersey, 08053
United States
Morristown Medical Center
Morristown, New Jersey, 07960
United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
United States
The Valley Hospital
Paramus, New Jersey, 07652
United States
SJH Cardiology Associates
Liverpool, New York, 13088
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
Weill Cornell Medical Center
New York, New York, 10021-9800
United States
Saint Francis Hospital
Roslyn, New York, 11576-1348
United States
Montefiore Medical Center
The Bronx, New York, 10467
United States
University of North Carolina
Chapel Hill, North Carolina, 27599
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
Sanford Medical Center
Fargo, North Dakota, 58102
United States
The Lindner Center
Cincinnati, Ohio, 45219
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Cleveland Cl inic
Cleveland, Ohio, 44195
United States
Riverside Methodist Hospital
Columbus, Ohio, 43214
United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120
United States
UPMC Harrisburg Hospital
Harrisburg, Pennsylvania, 17101
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
United States
Rhode Island Hospital and Health Services
Providence, Rhode Island, 02906
United States
AnMed Health Medical Center
Anderson, South Carolina, 29621
United States
Centennial Medical Center
Nashville, Tennessee, 37203
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
Dallas, Texas, 75226-1316
United States
DHR Health Institute for Research and Development
Edinburg, Texas, 78539
United States
Houston Methodist
Houston, Texas, 77030
United States
Baylor Scott & White The Heart Hospital Baylor Plano
Plano, Texas, 75093
United States
Methodist Hospital
San Antonio, Texas, 78229
United States
The University of Texas at Tyler
Tyler, Texas, 75701
United States
Intermountain Medical Center
Murray, Utah, 84107
United States
University of Vermont Medical Center
Burlington, Vermont, 05401
United States
UVA Medical Center
Charlottesville, Virginia, 22908
United States
Providence Regional Medical Center Everett
Everett, Washington, 98201
United States
West Virginia University
Morgantown, West Virginia, 26506
United States
Advocate Aurora Health-Aurora St. Luke's Medical Center (ASLMC)
Milwaukee, Wisconsin, 53215
United States

Collaborators and Investigators

Sponsor: Medtronic Vascular

  • David Kandzari, MD, PRINCIPAL_INVESTIGATOR, Piedmont Heart Institute
  • Felix Mahfoud, MD, PRINCIPAL_INVESTIGATOR, Saarland University Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-20
Study Completion Date2029-11-30

Study Record Updates

Study Start Date2021-10-20
Study Completion Date2029-11-30

Terms related to this study

Additional Relevant MeSH Terms

  • Hypertension
  • Vascular Diseases
  • Cardiovascular Diseases
  • Chronic Kidney Diseases
  • Diabetes Mellitus