SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study

NACompletedINTERVENTIONAL
Enrollment

366

Participants

Timeline

Start Date

June 30, 2015

Primary Completion Date

April 30, 2020

Study Completion Date

October 25, 2023

Conditions
HypertensionVascular DiseasesCardiovascular Diseases
Interventions
DEVICE

Symplicity Spyral™ multi-electrode renal denervation system

After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.

PROCEDURE

Sham Procedure

After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Trial Locations (47)

3004

Alfred Hospital, Melbourne

4600

Klinikum Wels-Grieskirchen, Wels

10029

Mount Sinai Medical Center, New York

11030

North Shore University Hospital, Manhasset

11527

Hippokration General Hospital of Athens, Athens

17011

PinnacleHealth Cardiovascular Institute, Harrisburg

19104

Hospital of the University of Pennsylvania, Philadelphia

23560

Sana Kliniken Lübeck, Lübeck

25304

Charleston Area Medical Center, Charleston

27710

Duke University Medical Center, Durham

29621

AnMed Health, Anderson

30308

Emory University Hospital Midtown, Atlanta

30309

Piedmont Heart Institute, Atlanta

32207

Baptist Medical Center Jacksonville, Jacksonville

32308

Tallahassee Research Institute, Tallahassee

35801

Heart Center Research, LLC, Huntsville

37203

Centennial Medical Center, Nashville

38801

Cardiology Associates Research LLC, Tupelo

39401

Hattiesburg Clinic, Hattiesburg

40536

University of Kentucky, Lexington

44106

University Hospitals Cleveland Medical Center, Cleveland

48075

Providence Hospital, Southfield

48341

St Joseph Mercy Oakland, Pontiac

50266

Iowa Heart Center, West Des Moines

53215

Aurora St. Luke's Medical Center, Milwaukee

54621

University General Hospital of Thessaloniki (AHEPA), Thessaloniki

55407

Minneapolis Heart Institute Foundation, Minneapolis

63110

Barnes-Jewish Hospital, St Louis

66421

Universitätsklinikum des Saarlandes, Homburg

75226

Baylor Heart & Vascular Hospital, Dallas

79189

Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH, Bad Krozingen

85258

Honor Health Research Institute, Scottsdale

90027

Kaiser Permanente LA Medical Center, Los Angeles

91054

Universitätsklinikum Erlangen, Erlangen

94305

Stanford Hospital and Clinics, Stanford

06520

Yale New Haven Hospital, New Haven

07039

Saint Barnabas Medical Center, Livingston

02906

The Miriam Hospital, Providence

M5B 1W8

St. Michael's Hospital, Toronto

H1T 1C8

Institut de cardiologie de Montréal / Montreal Heart Institute, Montreal

04289

Herzzentrum Leipzig, Universitätsklinik, Leipzig

Unknown

Galway University Hospital, Galway

Cardiff and Vale University Health Board - University Hospital of Wales, Cardiff

329-0498

Jichi Medical University Hospital, Shimotsuke

101-8643

Mitsui Memorial Hospital, Chiyoda City

EX2 5DW

Royal Devon & Exeter NHS Foundation Trust, Exeter

W12 0HS

Imperial College Healthcare NHS Trust, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Medtronic Vascular

INDUSTRY