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

NAActive, not recruitingINTERVENTIONAL
Enrollment

1,300

Participants

Timeline

Start Date

October 20, 2021

Primary Completion Date

November 30, 2026

Study Completion Date

November 30, 2029

Conditions
HypertensionVascular DiseasesCardiovascular DiseasesChronic Kidney DiseasesDiabetes Mellitus
Interventions
DEVICE

Renal Denervation (Symplicity Spyral™)

Device: Symplicity Spyral™ multi-electrode renal denervation system. After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure.

Trial Locations (100)

3004

The Alfred Hospital, Melbourne

3600

Ziekenhuis Oost Limburg - Campus Sint-Jan, Genk

4000

Chc Montlegia, Liège

6000

Royal Perth Hospital (Dobney Hypertension Centre), Perth

8000

AZ Sint Jan Brugge-Oostende av, Bruges

9000

University Hospital Ghent, Ghent

9300

Algemeen Stedelijk Ziekenhuis - R&D Hartziekten, Aalst

10467

Montefiore Medical Center, The Bronx

11030

North Shore University Hospital, Manhasset

11527

Hippokration General Hospital of Athens, Athens

13088

SJH Cardiology Associates, Liverpool

15212

Allegheny General Hospital, Pittsburgh

17101

UPMC Harrisburg Hospital, Harrisburg

18288

Danderyd Sjukhus, Stockholm

19104

Hospital of the University of Pennsylvania, Philadelphia

20010

MedStar Washington Hospital Center, Washington D.C.

21204

Saint Joseph Medical Center (Towson MD), Towson

21287

The Johns Hopkins Hospital, Baltimore

22908

UVA Medical Center, Charlottesville

23560

Sana Kliniken Lübeck GmbH, Lübeck

26506

West Virginia University, Morgantown

27599

University of North Carolina, Chapel Hill

27710

Duke University Medical Center, Durham

29621

AnMed Health Medical Center, Anderson

30060

Wellstar Research Institute, Marietta

30308

Emory University Hospital Midtown, Atlanta

30309

Piedmont Heart Institute, Atlanta

32207

Baptist Medical Center, Jacksonville

32308

Tallahassee Memorial Healthcare, Inc, Tallahassee

32803

AdventHealth Orlando, Orlando

32806

Orlando Health Heart & Vascular Institute, Orlando

33136

University of Miami Hosptial, Miami

33756

BayCare Health System, Clearwater

Clearwater Cardiovascular Consultants, Clearwater

34695

BayCare Medical Group, Safety Harbor

35233

University of Alabama at Birmingham (UAB) Hospital, Birmingham

35390

Justus-Liebig-Universität Gießen, Giessen

37203

Centennial Medical Center, Nashville

37232

Vanderbilt University Medical Center, Nashville

38801

North Mississippi Medical Center, Tupelo

43214

Riverside Methodist Hospital, Columbus

44106

University Hospitals Cleveland Medical Center, Cleveland

44195

Cleveland Cl inic, Cleveland

45219

The Lindner Center, Cincinnati

46290

St. Vincents Hospital, Indianapolis

48075

Henry Ford Providence Southfield Hospital, Southfield

48109

University of Michigan, Ann Arbor

48202

Henry Ford Hospital, Detroit

48236

Henry Ford Saint John Hospital, Detroit

48341

Saint Joseph Mercy Oakland, Pontiac

53215

Advocate Aurora Health-Aurora St. Luke's Medical Center (ASLMC), Milwaukee

55433

Metropolitan Heart and Vascular Institute (MHVI), Coon Rapids

58102

Sanford Medical Center, Fargo

60464

Heart Care Centers of Illinois, Palos Park

60637

University of Chicago Medicine, Chicago

68105

University of Nebraska Medical Center, Omaha

72205

Arkansas Cardiology, Little Rock

73120

Oklahoma Heart Hospital, Oklahoma City

75013

Hôpital Pitié Salpêtrière, Paris

75093

Baylor Scott & White The Heart Hospital Baylor Plano, Plano

75701

The University of Texas at Tyler, Tyler

77030

Houston Methodist, Houston

78229

Methodist Hospital, San Antonio

78539

DHR Health Institute for Research and Development, Edinburg

80045

University of Colorado Anschutz Medical Campus, Aurora

80228

Colorado Heart and Vascular PC, Lakewood

84107

Intermountain Medical Center, Murray

85016

Abrazo Arizona Heart Hospital/Biltmore Cardiology, Phoenix

85206

Banner Heart Hospital, Mesa

85258

HonorHealth Research Institute, Scottsdale

89102

University Medical Center of Southern Nevada, Las Vegas

91054

Uniklinik Erlangen, Erlangen

92037

Scripps Memorial Hospital, La Jolla

94143

University of California, San Francisco, San Francisco

94305

Stanford Hospital and Clinics, Stanford

98000

Centre Hospitalier Princesse Grace, Monaco

98201

Providence Regional Medical Center Everett, Everett

06102

Hartford Hospital, Hartford

60153-3328

Loyola University Medical Center, Maywood

50266-8209

Mercy Medical Center, West Des Moines

02215

Beth Israel Deaconess Medical Center, Boston

49503-2560

Spectrum Health Hospitals, Grand Rapids

56303-1900

CentraCare Heart & Vascular Center, Saint Cloud

03756

Dartmouth-Hitchcock, Lebanon

08053

Virtua Medical Group, Marlton

07960

Morristown Medical Center, Morristown

07753

Jersey Shore University Medical Center, Neptune City

07652

The Valley Hospital, Paramus

10021-9800

Weill Cornell Medical Center, New York

11576-1348

Saint Francis Hospital, Roslyn

02906

Rhode Island Hospital and Health Services, Providence

75226-1316

Baylor Jack and Jane Hamilton Heart and Vascular Hospital, Dallas

05401

University of Vermont Medical Center, Burlington

33 000

Hôpital Saint André -Centre Hospitalier Universitaire de Bordeaux, Bordeaux

Unknown

Universitatsklinikum des Saarlandes, Homburg

Erasmus Universtiy Medical Center, Rotterdam

04289

Herzzentrum Leipzig, Leipzig

D07 R2WY

Mater Misericordiae University Hospital, Dublin

6419 PC

Zuyderland Medisch Centrum Heerlen, Heerlen

OX3 9DU

John Radcliffe Hospital, Oxford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Medtronic Vascular

INDUSTRY

NCT05198674 - SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN | Biotech Hunter | Biotech Hunter