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COMPLETED
NCT02439775
NA

SPYRAL HTN-ON MED Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System

Sponsor: Medtronic Vascular

View on ClinicalTrials.gov

Summary

The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the presence of up to three standard antihypertensive medications.

Official title: Global Clinical Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension on Standard Medical Therapy (SPYRAL HTN-ON MED)

Key Details

Gender

All

Age Range

20 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

337

Start Date

2015-07-22

Completion Date

2025-08-14

Last Updated

2026-06-11

Healthy Volunteers

No

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.

Locations (56)

Heart Center Research, LLC

Huntsville, Alabama, United States

Stanford Hospital and Clinics

Stanford, California, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

Washington DC VA Medical Center

Washington D.C., District of Columbia, United States

Baptist Medical Center Jacksonville

Jacksonville, Florida, United States

Memorial Hospital Jacksonville

Jacksonville, Florida, United States

Tallahassee Research Institute

Tallahassee, Florida, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Piedmont Heart Institute

Atlanta, Georgia, United States

Iowa Heart Center

West Des Moines, Iowa, United States

University of Kentucky

Lexington, Kentucky, United States

St Joseph Mercy Oakland

Pontiac, Michigan, United States

Providence Hospital

Southfield, Michigan, United States

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Hattiesburg Clinic

Hattiesburg, Mississippi, United States

Cardiology Associates Research LLC

Tupelo, Mississippi, United States

Barnes-Jewish Hospital

St Louis, Missouri, United States

Saint Barnabas Medical Center

Livingston, New Jersey, United States

North Shore University Hospital

Manhasset, New York, United States

Weill Cornell Medical College/The New York Presbyterian Hospital

New York, New York, United States

Mount Sinai Medical Center

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Oregon Health & Science University Hospital

Portland, Oregon, United States

PinnacleHealth Cardiovascular Institute

Harrisburg, Pennsylvania, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

The Miriam Hospital

Providence, Rhode Island, United States

AnMed Health

Anderson, South Carolina, United States

Centennial Medical Center

Nashville, Tennessee, United States

Baylor Heart & Vascular Hospital

Dallas, Texas, United States

Charleston Area Medical Center

Charleston, West Virginia, United States

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Alfred Hospital

Melbourne, Victoria, Australia

St. George Hospital

Kogarah, Australia

Royal Perth

Perth, Australia

Klinikum Wels-Grieskirchen

Wels, Austria

Hamilton Heath

Hamilton, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Clinique Pasteur

Toulouse, France

Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH

Bad Krozingen, Germany

Universitätsklinikum Erlangen

Erlangen, Germany

Universitätsklinikum des Saarlandes

Homburg, Germany

Herzzentrum Leipzig, Universitätsklinik

Leipzig, Germany

Sana Kliniken Lübeck

Lübeck, Germany

Hippokration General Hospital of Athens

Athens, Greece

University General Hospital of Thessaloniki (AHEPA)

Thessaloniki, Greece

Galway University Hospital

Galway, Ireland

Higashi Takarazuka Satoh Hospital

Takarazuka, Hyōgo, Japan

Shonan Kamakura General Hospital

Kamakura, Okamoto, Japan

Jichi Medical University Hospital

Shimotsuke, Tochigi, Japan

Mitsui Memorial Hospital

Chiyoda City, Tokyo, Japan

Saiseikai Nakatsu Hospital

Osaka, Japan

Royal Bournemouth Hospital

Bournemouth, United Kingdom

Cardiff and Vale University Health Board - University Hospital of Wales

Cardiff, United Kingdom

Royal Devon & Exeter NHS Foundation Trust

Exeter, United Kingdom

Imperial College Healthcare NHS Trust

London, United Kingdom