Clinical trial NCT05198674: SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Vascular Diseases
Cardiovascular Diseases
Chronic Kidney Diseases
Diabetes Mellitus
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
First posted: 2022-01-20
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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%

Primary outcomes:
measure: The Primary endpoint of office Systolic Blood Pressure (SBP) change at 6 months.
timeFrame: 6 months
Secondary outcomes:
measure: Office Systolic Blood Pressure change
timeFrame: From baseline to 3, 6, 12, 24, and 36 months post-procedure
measure: Home Blood Pressure change (Main Cohort Only)
timeFrame: From baseline to 3, 6, 12, 24, and 36 months post-procedure
measure: Change in blood pressure as measured by 24-hour ABPM
timeFrame: From baseline to 3, 6, 12, 24, and 36 months post-procedure
measure: Percent of subjects achieving blood pressure control as measured by OBP, HBP and ABPM
timeFrame: From baseline to 3, 6, 12, 24, and 36 months post-procedure
measure: Time subject's blood pressure is controlled
timeFrame: Procedure to 36 months post-procedure
measure: Change in number of anti-hypertensive medications taken from baseline
timeFrame: From baseline to 3, 6, 12, 24, and 36 months post-procedure
measure: Change from baseline in EQ-5D quality of life score
timeFrame: From baseline to 3, 6, 12, 24, and 36 months post-procedure
measure: Change from baseline in hypertension health status score
timeFrame: From baseline to 3, 6, 12, 24, and 36 months post-procedure
measure: 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
timeFrame: From baseline to 3, 6, 12, 24, and 36 months post-procedure
measure: Evaluation of slope of eGFR
timeFrame: From baseline to 3, 6, 12, 24, and 36 months post-procedure
measure: Incidence of events, including major adverse events
timeFrame: From baseline to 3, 6, 12, 24, and 36 months post-procedure
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham (UAB) Hospital
state: Alabama
city: Mesa
country: United States
facility: Banner Heart Hospital
state: Arizona
city: Phoenix
country: United States
facility: Abrazo Arizona Heart Hospital/Biltmore Cardiology
state: Arizona
city: Scottsdale
country: United States
facility: HonorHealth Research Institute
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Cardiology
state: Arkansas
city: La Jolla
country: United States
facility: Scripps Memorial Hospital
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Stanford
country: United States
facility: Stanford Hospital and Clinics
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Lakewood
country: United States
facility: Colorado Heart and Vascular PC
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Clearwater
country: United States
facility: BayCare Health System
state: Florida
city: Clearwater
country: United States
facility: Clearwater Cardiovascular Consultants
state: Florida
city: Jacksonville
country: United States
facility: Baptist Medical Center
state: Florida
city: Miami
country: United States
facility: University of Miami Hosptial
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Orlando
country: United States
facility: Orlando Health Heart & Vascular Institute
state: Florida
city: Safety Harbor
country: United States
facility: BayCare Medical Group
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Healthcare, Inc
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Marietta
country: United States
facility: Wellstar Research Institute
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medicine
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Palos Park
country: United States
facility: Heart Care Centers of Illinois
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincents Hospital
state: Indiana
city: West Des Moines
country: United States
facility: Mercy Medical Center
state: Iowa
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
city: Towson
country: United States
facility: Saint Joseph Medical Center (Towson MD)
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Saint John Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Hospitals
state: Michigan
city: Pontiac
country: United States
facility: Saint Joseph Mercy Oakland
state: Michigan
city: Southfield
country: United States
facility: Henry Ford Providence Southfield Hospital
state: Michigan
city: Coon Rapids
country: United States
facility: Metropolitan Heart and Vascular Institute (MHVI)
state: Minnesota
city: Saint Cloud
country: United States
facility: CentraCare Heart & Vascular Center
state: Minnesota
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Las Vegas
country: United States
facility: University Medical Center of Southern Nevada
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock
state: New Hampshire
city: Marlton
country: United States
facility: Virtua Medical Group
state: New Jersey
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Paramus
country: United States
facility: The Valley Hospital
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Liverpool
country: United States
facility: SJH Cardiology Associates
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
city: Roslyn
country: United States
facility: Saint Francis Hospital
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Fargo
country: United States
facility: Sanford Medical Center
state: North Dakota
city: Cincinnati
country: United States
facility: The Lindner Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Cl inic
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
city: Harrisburg
country: United States
facility: UPMC Harrisburg Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital and Health Services
state: Rhode Island
city: Anderson
country: United States
facility: AnMed Health Medical Center
state: South Carolina
city: Nashville
country: United States
facility: Centennial Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor Jack and Jane Hamilton Heart and Vascular Hospital
state: Texas
city: Edinburg
country: United States
facility: DHR Health Institute for Research and Development
state: Texas
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Plano
country: United States
facility: Baylor Scott & White The Heart Hospital Baylor Plano
state: Texas
city: San Antonio
country: United States
facility: Methodist Hospital
state: Texas
city: Tyler
country: United States
facility: The University of Texas at Tyler
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
city: Charlottesville
country: United States
facility: UVA Medical Center
state: Virginia
city: Everett
country: United States
facility: Providence Regional Medical Center Everett
state: Washington
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Milwaukee
country: United States
facility: Advocate Aurora Health-Aurora St. Luke's Medical Center (ASLMC)
state: Wisconsin
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Perth
country: Australia
facility: Royal Perth Hospital (Dobney Hypertension Centre)
state: Western Australia
city: Aalst
country: Belgium
facility: Algemeen Stedelijk Ziekenhuis - R&D Hartziekten
state: Oost - Vlaanderen
city: Brugge
country: Belgium
facility: AZ Sint Jan Brugge-Oostende av
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg - Campus Sint-Jan
city: Gent
country: Belgium
facility: University Hospital Ghent
city: Liège
country: Belgium
facility: Chc Montlegia
city: Bordeaux
country: France
facility: Hôpital Saint André -Centre Hospitalier Universitaire de Bordeaux
city: Paris
country: France
facility: Hôpital Pitié Salpêtrière
city: Erlangen
country: Germany
facility: Uniklinik Erlangen
city: Gießen
country: Germany
facility: Justus-Liebig-Universität Gießen
city: Homburg
country: Germany
facility: Universitatsklinikum des Saarlandes
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
city: Lübeck
country: Germany
facility: Sana Kliniken Lübeck GmbH
city: Athens
country: Greece
facility: Hippokration General Hospital of Athens
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
city: Monaco
country: Monaco
facility: Centre Hospitalier Princesse Grace
city: Heerlen
country: Netherlands
facility: Zuyderland Medisch Centrum Heerlen
city: Rotterdam
country: Netherlands
facility: Erasmus Universtiy Medical Center
city: Stockholm
country: Sweden
facility: Danderyd Sjukhus
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
state: Oxfordshire
Study officials:
affiliation: Piedmont Heart Institute
name: David Kandzari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Saarland University Hospital
name: Felix Mahfoud, MD
role: PRINCIPAL_INVESTIGATOR
References: