This trial is no longer recruiting

Recruitment for this study has ended, so applications are closed. You can still read the trial details, or browse similar trials that are currently recruiting.

Not recruiting

RDN

Sponsor:

Medtronic Vascular

Code:

NCT05198674

Conditions

Hypertension

Vascular Diseases

Cardiovascular Diseases

Chronic Kidney Diseases

Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Renal Denervation (Symplicity Spyral™)

Study Details

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.

Conditions

Hypertension

Vascular Diseases

Cardiovascular Diseases

Chronic Kidney Diseases

Diabetes Mellitus

Study ID

NCT05198674

Start date

Oct 20, 2021

Status verified date

Jun, 2025

Completion date

Nov 30, 2029

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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%

Study Design

Enrollment

1400 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Main Cohort: Renal Denervation

Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)

Interventions

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.

Primary outcome measure

  • The Primary endpoint of office Systolic Blood Pressure (SBP) change at 6 months. [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

University of Alabama at Birmingham (UAB) Hospital

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Principal Investigator:

Mustafa Ahmed, MD

Banner Heart Hospital

Recruiting

Mesa, Arizona, United States, 85206

Contacts

Robert Flynn

480-412-6859

Principal Investigator:

Jaskamal Kahlon

Abrazo Arizona Heart Hospital/Biltmore Cardiology

Recruiting

Phoenix, Arizona, United States, 85016

Contacts

Principal Investigator:

Timothy Byrne

HonorHealth Research Institute

Recruiting

Scottsdale, Arizona, United States, 85258

Contacts

Principal Investigator:

Taral Patel, MD

Arkansas Cardiology

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Principal Investigator:

Dwight Chrisman, MD

Scripps Memorial Hospital

Recruiting

La Jolla, California, United States, 92037

Contacts

Janet Lawrence, BA, CCRC

858-824-4168

Christina Nava, CCRP

858-824-5244

Principal Investigator:

Paul S. Teirstein, MD, FACC

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Principal Investigator:

Sammy Elmariah, MD, MPH

Stanford Hospital and Clinics

Recruiting

Stanford, California, United States, 94305

Contacts

Principal Investigator:

David P. Lee, MD

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Principal Investigator:

Kevin Rogers, Dr

Colorado Heart and Vascular PC

Recruiting

Lakewood, Colorado, United States, 80228

Contacts

Principal Investigator:

John Altman, MD

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06102

Contacts

Principal Investigator:

Joseph Ingrassia, MD

MedStar Washington Hospital Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Principal Investigator:

Nelson Bernardo, MD

BayCare Health System

Recruiting

Clearwater, Florida, United States, 33756

Principal Investigator:

Parag Patel

Clearwater Cardiovascular Consultants

Recruiting

Clearwater, Florida, United States, 33756

Contacts

Principal Investigator:

Douglas Spriggs, MD

Baptist Medical Center

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

University of Miami Hosptial

Recruiting

Miami, Florida, United States, 33136

Contacts

Karla Duarte

(305)243-0256

Christian Marin y Kall, MD, MBA

(305)243-2119

Principal Investigator:

Eduardo de Marchena, MD

AdventHealth Orlando

Recruiting

Orlando, Florida, United States, 32803

Contacts

Maggie Warrington, RN

407-303-7556

Principal Investigator:

Nipun Arora, MD

Orlando Health Heart & Vascular Institute

Recruiting

Orlando, Florida, United States, 32806

Contacts

Principal Investigator:

Farhan J. Khawaja, MD

BayCare Medical Group

Recruiting

Safety Harbor, Florida, United States, 34695

Contacts

Principal Investigator:

Parag Patel, MD

Tallahassee Memorial Healthcare, Inc

Recruiting

Tallahassee, Florida, United States, 32308

Contacts

Katherine Gearld, LPN, CCRC

850-431-5024katherine.gearld@tmh.org

Principal Investigator:

Thomas Noel, MD

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Principal Investigator:

Chandan Devireddy, MD

Piedmont Heart Institute

Recruiting

Atlanta, Georgia, United States, 30309

Wellstar Research Institute

Recruiting

Marietta, Georgia, United States, 30060

Contacts

Stacey Mitchell

470-793-4042

Principal Investigator:

Salvatore Mannino, MD

University of Chicago Medicine

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Michaela K McSweeney, RN-BC

7737027308mmcsweeney@bsd.uchciago.edu

Principal Investigator:

Sandeep Nathan, MD

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153-3328

Contacts

Bruce Lewis, MD

708-216-9447

Principal Investigator:

Bruce Lewis, MD

Heart Care Centers of Illinois

Recruiting

Palos Park, Illinois, United States, 60464

St. Vincents Hospital

Recruiting

Indianapolis, Indiana, United States, 46290

Mercy Medical Center

Recruiting

West Des Moines, Iowa, United States, 50266-8209

Contacts

Principal Investigator:

Magdi Ghali, MD

The Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Michele Fisher, LPN/RCS

410-955-6839mfishe36@jhmi.edu

Mary Kate Dougherty, BS

Mdough10@jhu.edu

Principal Investigator:

Rohan Kalathiya, MD

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Eric Secemsky, MD

617-667-8800

Jenifer Kaufman

617-632-8956

Principal Investigator:

Eric Secemsky, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Allison Schley

schleya@med.umich.edu

Principal Investigator:

Paul Michael Grossman

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Michelle Butcher, RN, BS

313-916-0015Mbutche1@hfhs.org

Melanee Schimmel, RN, BS

313-916-7614Mschimm2@hfhs.org

Henry Ford Saint John Hospital

Recruiting

Detroit, Michigan, United States, 48236

Contacts

Principal Investigator:

Amir Kaki, MD

Spectrum Health Hospitals

Recruiting

Grand Rapids, Michigan, United States, 49503-2560

Saint Joseph Mercy Oakland

Recruiting

Pontiac, Michigan, United States, 48341

Principal Investigator:

Kiritkumar Patel

Henry Ford Providence Southfield Hospital

Recruiting

Southfield, Michigan, United States, 48075

Contacts

Principal Investigator:

Shukri David, MD

Metropolitan Heart and Vascular Institute (MHVI)

Recruiting

Coon Rapids, Minnesota, United States, 55433

Contacts

Derek Vang, MBSc, CCRC

763-236-9347derek.vang@mhvi.com

Principal Investigator:

Matthew Whitbeck, MD

CentraCare Heart & Vascular Center

Recruiting

Saint Cloud, Minnesota, United States, 56303-1900

Contacts

Principal Investigator:

Jacob Dutcher, MD

North Mississippi Medical Center

Recruiting

Tupelo, Mississippi, United States, 38801

Contacts

Principal Investigator:

Barry Bertolet, MD

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68105

Contacts

Edward O'Leary, MD

402 559-4874

Nichole Coltrain, RN

402 559-0232

Principal Investigator:

Edward O'Leary, MD

University Medical Center of Southern Nevada

Recruiting

Las Vegas, Nevada, United States, 89102

Contacts

Jennifer Robinson, CCRC

702-383-7842

Principal Investigator:

Chowdhury Ahsan, MD

Dartmouth-Hitchcock

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Brian J. Aldrich, BS, BA, CCRP, CCRC, ACRP-MDP

6036506228Brian.J.Aldrich@hitchcock.org

Principal Investigator:

James DeVries, MD

Virtua Medical Group

Recruiting

Marlton, New Jersey, United States, 08053

Contacts

Principal Investigator:

Kintur Sanghvi, MD

Morristown Medical Center

Recruiting

Morristown, New Jersey, United States, 07960

Jersey Shore University Medical Center

Recruiting

Neptune City, New Jersey, United States, 07753

Contacts

Principal Investigator:

Matthew Saybolt, MD

The Valley Hospital

Recruiting

Paramus, New Jersey, United States, 07652

Contacts

Rajiv Tayal, MD

201-447-8453

Principal Investigator:

Rajiv Tayal, MD

SJH Cardiology Associates

Recruiting

Liverpool, New York, United States, 13088

Contacts

Principal Investigator:

Ayman Iskander

North Shore University Hospital

Recruiting

Manhasset, New York, United States, 11030

Contacts

Ian Dalangin

(516) 562-2457

Salome Elia Reddy

(516) 562-1385

Principal Investigator:

Avneet Singh, MD

Weill Cornell Medical Center

Recruiting

New York, New York, United States, 10021-9800

Contacts

Principal Investigator:

Dmitriy Feldman, MD

Saint Francis Hospital

Recruiting

Roslyn, New York, United States, 11576-1348

Contacts

Principal Investigator:

Doosup Shin, MD

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

Principal Investigator:

Mohamed Latib, MD

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Principal Investigator:

Rick Stouffer, MD

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Principal Investigator:

Manesh Patel, MD

Sanford Medical Center

Recruiting

Fargo, North Dakota, United States, 58102

Contacts

Principal Investigator:

Yasser Almanaseer

The Lindner Center

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Principal Investigator:

John Corl, MD

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Principal Investigator:

Mehdi Shishehbor

Cleveland Cl inic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Principal Investigator:

Khaled Ziada

Riverside Methodist Hospital

Recruiting

Columbus, Ohio, United States, 43214

Contacts

Principal Investigator:

Joseph D. Campbell, MD

Oklahoma Heart Hospital

Recruiting

Oklahoma City, Oklahoma, United States, 73120

Principal Investigator:

Mohammad Ghani

UPMC Harrisburg Hospital

Recruiting

Harrisburg, Pennsylvania, United States, 17101

Contacts

Gretchen C Meise, RN BSN

717 920 4464meisegc@upmc.edu

Joanna L Miller, RN BSN

717 920 4463Millerjl30@upmc.edu

Principal Investigator:

William Bachinsky

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

Debbie Cohen, MD

Allegheny General Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Ramzi Khalil, MD

412-359-4025

Tracy Spirk

412-359-4025

Principal Investigator:

Ramzi Khalil, MD

Rhode Island Hospital and Health Services

Recruiting

Providence, Rhode Island, United States, 02906

Contacts

Lori-Ann DeSimone

ldesimone@lifespan.org

Principal Investigator:

Omar Hyder, MD

AnMed Health Medical Center

Recruiting

Anderson, South Carolina, United States, 29621

Contacts

Principal Investigator:

Brent McLaurin, MD

Centennial Medical Center

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Principal Investigator:

Brian Jefferson, MD

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Principal Investigator:

Pete Fong, MD

Baylor Jack and Jane Hamilton Heart and Vascular Hospital

Recruiting

Dallas, Texas, United States, 75226-1316

DHR Health Institute for Research and Development

Recruiting

Edinburg, Texas, United States, 78539

Contacts

Clarisa Crystal Medina, BS

956-362-2390c.medina@dhr-rgv.com

Principal Investigator:

Michael Seawell, MD

Houston Methodist

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Alpesh Shah, MD

Baylor Scott & White The Heart Hospital Baylor Plano

Recruiting

Plano, Texas, United States, 75093

Methodist Hospital

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Aliseiya Garza, BS

210-449-5026

Maurene Cantu, RN

210-218-4950

Principal Investigator:

Jorge Alvarez, MD

The University of Texas at Tyler

Recruiting

Tyler, Texas, United States, 75701

Contacts

Kevin Thornton, LVN, CCRC

903-510-7295kevin.thornton@uthet.com

Elizabeth Seal, CCRC

903-510-7291eseal@uthet.com

Principal Investigator:

Frank Navetta, MD

Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84107

Contacts

Principal Investigator:

Kent Meredith, MD

University of Vermont Medical Center

Recruiting

Burlington, Vermont, United States, 05401

Contacts

Principal Investigator:

Rony Lahoud, MD

UVA Medical Center

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Kelly Parker, RN, CCRC

434-982-1058

Linda Bryceland, RN, CCRC

434-982-1058

Principal Investigator:

Kanwar Singh

Providence Regional Medical Center Everett

Recruiting

Everett, Washington, United States, 98201

Contacts

Principal Investigator:

Mahesh Mulumudi, MD

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Principal Investigator:

Ramesh Daggubati, MD

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

Recruiting

Milwaukee, Wisconsin, United States, 53215

Contacts

Principal Investigator:

Suhail Allaqaband, MD

More Information

Sponsor

Medtronic Vascular

Last update posted

Aug 15, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-22. This information was provided to ClinicalTrials.gov by Medtronic Vascular on 2025-08-15.