SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN
- Conditions
- HypertensionChronic Kidney DiseasesDiabetes MellitusVascular DiseasesCardiovascular Diseases
- Interventions
- Device: Renal Denervation (Symplicity Spyral™)
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1400
- Individual is diagnosed with hypertension and has a baseline office systolic blood pressure ≥140 mmHg
- Individual has a baseline office diastolic blood pressure ≥ 90 mmHg
- Individual has an average systolic baseline home blood pressure ≥135 mmHg
- Individual lacks appropriate renal artery anatomy
- Individual has undergone prior renal denervation
- Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement
- Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
- Individual has an estimated glomerular filtration rate (eGFR) of <45
- Individual has one or more episode(s) of orthostatic hypotension
- Individual is pregnant, nursing or planning to become pregnant
- Individual has primary pulmonary hypertension
- 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
- Arm && Interventions
Group Intervention Description Main Cohort: Renal Denervation Renal Denervation (Symplicity Spyral™) Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
- 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 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 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 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 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 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
Trial Locations
- Locations (99)
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
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
BayCare Health System
🇺🇸Clearwater, Florida, United States
Clearwater Cardiovascular Consultants
🇺🇸Clearwater, Florida, United States
Baptist Medical Center
🇺🇸Jacksonville, Florida, United States
University of Miami Hosptial
🇺🇸Miami, Florida, United States
AdventHealth Orlando
🇺🇸Orlando, Florida, United States
Orlando Health Heart & Vascular Institute
🇺🇸Orlando, Florida, United States
BayCare Medical Group
🇺🇸Safety Harbor, Florida, United States
Tallahassee Memorial Healthcare, Inc
🇺🇸Tallahassee, Florida, United States
Emory University Hospital Midtown
🇺🇸Atlanta, Georgia, United States
Piedmont Heart Institute
🇺🇸Atlanta, Georgia, United States
Wellstar Research Institute
🇺🇸Marietta, Georgia, United States
University of Chicago Medicine
🇺🇸Chicago, Illinois, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Heart Care Centers of Illinois
🇺🇸Palos Park, Illinois, United States
St. Vincents Hospital
🇺🇸Indianapolis, Indiana, United States
Mercy Medical Center
🇺🇸West Des Moines, Iowa, United States
The Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Universitatsklinikum des Saarlandes
🇩🇪Homburg, Germany
Saint Joseph Medical Center (Towson MD)
🇺🇸Towson, Maryland, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Henry Ford Saint John Hospital
🇺🇸Detroit, Michigan, United States
Spectrum Health Hospitals
🇺🇸Grand Rapids, Michigan, United States
Saint Joseph Mercy Oakland
🇺🇸Pontiac, Michigan, United States
Henry Ford Providence Southfield Hospital
🇺🇸Southfield, Michigan, United States
Metropolitan Heart and Vascular Institute (MHVI)
🇺🇸Coon Rapids, Minnesota, United States
CentraCare Heart & Vascular Center
🇺🇸Saint Cloud, Minnesota, United States
North Mississippi Medical Center
🇺🇸Tupelo, Mississippi, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
University Medical Center of Southern Nevada
🇺🇸Las Vegas, Nevada, United States
Dartmouth-Hitchcock
🇺🇸Lebanon, New Hampshire, United States
Virtua Medical Group
🇺🇸Marlton, New Jersey, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
The Valley Hospital
🇺🇸Paramus, New Jersey, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
SJH Cardiology Associates
🇺🇸Liverpool, New York, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Weill Cornell Medical Center
🇺🇸New York, New York, United States
Saint Francis Hospital
🇺🇸Roslyn, New York, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Sanford Medical Center
🇺🇸Fargo, North Dakota, United States
The Lindner Center
🇺🇸Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Cleveland Cl inic
🇺🇸Cleveland, Ohio, United States
Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
Oklahoma Heart Hospital
🇺🇸Oklahoma City, Oklahoma, United States
UPMC Harrisburg Hospital
🇺🇸Harrisburg, Pennsylvania, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Rhode Island Hospital and Health Services
🇺🇸Providence, Rhode Island, United States
AnMed Health Medical Center
🇺🇸Anderson, South Carolina, United States
Centennial Medical Center
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
🇺🇸Dallas, Texas, United States
DHR Health Institute for Research and Development
🇺🇸Edinburg, Texas, United States
Herzzentrum Leipzig
🇩🇪Leipzig, Germany
Houston Methodist
🇺🇸Houston, Texas, United States
Baylor Scott & White The Heart Hospital Baylor Plano
🇺🇸Plano, Texas, United States
Methodist Hospital
🇺🇸San Antonio, Texas, United States
The University of Texas at Tyler
🇺🇸Tyler, Texas, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
UVA Medical Center
🇺🇸Charlottesville, Virginia, United States
Providence Regional Medical Center Everett
🇺🇸Everett, Washington, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
Advocate Aurora Health-Aurora St. Luke's Medical Center (ASLMC)
🇺🇸Milwaukee, Wisconsin, United States
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Royal Perth Hospital (Dobney Hypertension Centre)
🇦🇺Perth, Western Australia, Australia
Algemeen Stedelijk Ziekenhuis - R&D Hartziekten
🇧🇪Aalst, Oost - Vlaanderen, Belgium
AZ Sint Jan Brugge-Oostende av
🇧🇪Brugge, Belgium
Ziekenhuis Oost Limburg - Campus Sint-Jan
🇧🇪Genk, Belgium
University Hospital Ghent
🇧🇪Gent, Belgium
Chc Montlegia
🇧🇪Liège, Belgium
Hôpital Saint André -Centre Hospitalier Universitaire de Bordeaux
🇫🇷Bordeaux, France
Hôpital Pitié Salpêtrière
🇫🇷Paris, France
Uniklinik Erlangen
🇩🇪Erlangen, Germany
Justus-Liebig-Universität Gießen
🇩🇪Gießen, Germany
Sana Kliniken Lübeck GmbH
🇩🇪Lübeck, Germany
Hippokration General Hospital of Athens
🇬🇷Athens, Greece
Mater Misericordiae University Hospital
🇮🇪Dublin, Ireland
Centre Hospitalier Princesse Grace
🇲🇨Monaco, Monaco
Zuyderland Medisch Centrum Heerlen
🇳🇱Heerlen, Netherlands
Erasmus Universtiy Medical Center
🇳🇱Rotterdam, Netherlands
Danderyd Sjukhus
🇸🇪Stockholm, Sweden
John Radcliffe Hospital
🇬🇧Oxford, Oxfordshire, United Kingdom