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

Primary Purpose

Hypertension, Vascular Diseases, Cardiovascular Diseases

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Renal Denervation (Symplicity Spyral™)
Sponsored by
Medtronic Vascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1. Individual is diagnosed with hypertension and has a baseline office systolic blood pressure ≥140 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 <30
  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

Sites / Locations

  • HonorHealth Research InstituteRecruiting
  • Arkansas CardiologyRecruiting
  • University of Colorado Anschutz Medical CampusRecruiting
  • Hartford HospitalRecruiting
  • Clearwater Cardiovascular ConsultantsRecruiting
  • Baptist Medical CenterRecruiting
  • Orlando Health Heart & Vascular InstituteRecruiting
  • Piedmont Heart InstituteRecruiting
  • Wellstar Research InstituteRecruiting
  • University of Chicago MedicineRecruiting
  • Loyola University Medical CenterRecruiting
  • Heart Care Centers of IllinoisRecruiting
  • St. Vincents HospitalRecruiting
  • Mercy Medical CenterRecruiting
  • Beth Israel Deaconess Medical CenterRecruiting
  • Ascension St. John HospitalRecruiting
  • Spectrum Health HospitalsRecruiting
  • Saint Joseph Mercy OaklandRecruiting
  • Ascension Providence HospitalRecruiting
  • Metropolitan Heart and Vascular Institute (MHVI)Recruiting
  • CentraCare Heart & Vascular CenterRecruiting
  • North Mississippi Medical CenterRecruiting
  • Morristown Medical CenterRecruiting
  • Montefiore Medical CenterRecruiting
  • SJH Cardiology AssociatesRecruiting
  • Weill Cornell Medical CenterRecruiting
  • The Lindner CenterRecruiting
  • Riverside Methodist HospitalRecruiting
  • Oklahoma Heart HospitalRecruiting
  • UPMC Harrisburg HospitalRecruiting
  • Hospital of the University of PennsylvaniaRecruiting
  • Allegheny General HospitalRecruiting
  • AnMed Health Medical CenterRecruiting
  • Centennial Medical CenterRecruiting
  • Baylor Jack and Jane Hamilton Heart and Vascular HospitalRecruiting
  • Baylor Scott & White The Heart Hospital Baylor PlanoRecruiting
  • Methodist HospitalRecruiting
  • The University of Texas at TylerRecruiting
  • University of Vermont Medical CenterRecruiting
  • UVA Medical CenterRecruiting
  • Providence Regional Medical Center EverettRecruiting
  • Algemeen Stedelijk Ziekenhuis - R&D HartziektenRecruiting
  • AZ Sint Jan Brugge-Oostende avRecruiting
  • Ziekenhuis Oost Limburg - Campus Sint-JanRecruiting
  • University Hospital GhentRecruiting
  • Chc MontlegiaRecruiting
  • Uniklinik ErlangenRecruiting
  • Universitatsklinikum des SaarlandesRecruiting
  • Herzzentrum LeipzigRecruiting
  • Sana Kliniken Lübeck GmbHRecruiting
  • Zuyderland Medisch Centrum HeerlenRecruiting
  • Erasmus Universtiy Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Main Cohort: Renal Denervation

Arm Description

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

Outcomes

Primary Outcome Measures

Change in Office Systolic Blood Pressure - Subgroup Chronic Kidney Disease
Change in systolic blood pressure from baseline as measured by office blood pressure in subjects with chronic kidney disease.
Office Systolic Blood Pressure change at 6 months - Subgroup Isolated Systolic Hypertension
Change in systolic blood pressure from baseline as measured by office blood pressure in subjects with Isolated systolic hypertension
Office Systolic Blood Pressure change at 6 months - Subgroup Diabetes (Type II)
Change in systolic blood pressure from baseline as measured by office blood pressure in subjects with Diabetes (Type II)

Secondary Outcome Measures

Office Systolic Blood Pressure change
Home Blood Pressure change (Main Cohort Only)
Change in blood pressure as measured by 24-hour ABPM
Percent of subjects achieving blood pressure control as measured by OBP, HBP and ABPM
Time subject's blood pressure is controlled
Change in number of anti-hypertensive medications taken from baseline
Change from baseline in EQ-5D quality of life score
Change from baseline in hypertension health status score
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
Percent of subjects requiring repeat renal denervation
Incidence of major adverse events
Evaluation of slope of eGFR

Full Information

First Posted
November 5, 2021
Last Updated
October 9, 2023
Sponsor
Medtronic Vascular
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1. Study Identification

Unique Protocol Identification Number
NCT05198674
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2021 (Actual)
Primary Completion Date
January 22, 2024 (Anticipated)
Study Completion Date
June 7, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Vascular

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Vascular Diseases, Cardiovascular Diseases, Chronic Kidney Diseases, Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Main Cohort: Renal Denervation
Arm Type
Experimental
Arm Description
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
Intervention Type
Device
Intervention Name(s)
Renal Denervation (Symplicity Spyral™)
Other Intervention Name(s)
Renal Angiography, Renal Denervation
Intervention Description
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 Information:
Title
Change in Office Systolic Blood Pressure - Subgroup Chronic Kidney Disease
Description
Change in systolic blood pressure from baseline as measured by office blood pressure in subjects with chronic kidney disease.
Time Frame
From baseline to 6 months post-procedure
Title
Office Systolic Blood Pressure change at 6 months - Subgroup Isolated Systolic Hypertension
Description
Change in systolic blood pressure from baseline as measured by office blood pressure in subjects with Isolated systolic hypertension
Time Frame
From baseline to 6 months post-procedure
Title
Office Systolic Blood Pressure change at 6 months - Subgroup Diabetes (Type II)
Description
Change in systolic blood pressure from baseline as measured by office blood pressure in subjects with Diabetes (Type II)
Time Frame
From baseline to 6 months post-procedure
Secondary Outcome Measure Information:
Title
Office Systolic Blood Pressure change
Time Frame
From baseline to 3, 6, 12, 24, and 36 months post-procedure
Title
Home Blood Pressure change (Main Cohort Only)
Time Frame
From baseline to 3, 6, 12, 24, and 36 months post-procedure
Title
Change in blood pressure as measured by 24-hour ABPM
Time Frame
From baseline to 3, 6, 12, 24, and 36 months post-procedure
Title
Percent of subjects achieving blood pressure control as measured by OBP, HBP and ABPM
Time Frame
From Procedure to 3, 6, 12, 24, and 36 months post-procedure
Title
Time subject's blood pressure is controlled
Time Frame
Procedure to 36 months post-procedure
Title
Change in number of anti-hypertensive medications taken from baseline
Time Frame
From baseline to 3, 6, 12, 24, and 36 months post-procedure
Title
Change from baseline in EQ-5D quality of life score
Time Frame
From baseline to 3, 6, 12, 24, and 36 months post-procedure
Title
Change from baseline in hypertension health status score
Time Frame
From baseline to 3, 6, 12, 24, and 36 months post-procedure
Title
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
Time Frame
From baseline to 3, 6, 12, 24, and 36 months post-procedure
Title
Percent of subjects requiring repeat renal denervation
Time Frame
From baseline to 3, 6, 12, 24, and 36 months post-procedure
Title
Incidence of major adverse events
Time Frame
From baseline to 3, 6, 12, 24, and 36 months post-procedure
Title
Evaluation of slope of eGFR
Time Frame
From baseline to 3, 6, 12, 24, and 36 months post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Individual is diagnosed with hypertension and has a baseline office systolic blood pressure ≥140 mmHg Exclusion Criteria: Individual lacks appropriate renal artery anatomy Individual has undergone prior renal denervation Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea Individual has an estimated glomerular filtration rate (eGFR) of <30 Individual has one or more episode(s) of orthostatic hypotension Individual is pregnant, nursing or planning to become pregnant Individual has primary pulmonary hypertension
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelsey Anderson
Phone
+17635149730
Email
kelsey.m.anderson@medtronic.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Kandzari, MD
Organizational Affiliation
Piedmont Heart Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Felix Mahfoud, MD
Organizational Affiliation
Saarland University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
HonorHealth Research Institute
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Devin Howard, RN
Phone
480-323-1046
Email
devihoward@honorhealth.com
First Name & Middle Initial & Last Name & Degree
Alisha Vandriel
Phone
480) 323-1046
Email
avandriel@honorhealth.com
First Name & Middle Initial & Last Name & Degree
Taral Patel, MD
First Name & Middle Initial & Last Name & Degree
Mayurkumar Bhakta, MD
Facility Name
Arkansas Cardiology
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bobbi Philips
Phone
501-227-7596
Ext
1263
Email
bphillips@arcard.org
First Name & Middle Initial & Last Name & Degree
Stacy Canerday, RN
Email
scanerday@arcard.org
First Name & Middle Initial & Last Name & Degree
Dwight Chrisman, MD
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tanner Bloks, PRA
Phone
303-724-3938
Email
Tanner.bloks@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Emanuel Gereab, PRA
Phone
303-724-5683
Email
emanuel.gebreab@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Kevin Rogers, Dr
First Name & Middle Initial & Last Name & Degree
Bricker Rory, Dr
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Ingrassia, MD
Phone
860-972-3570
Email
Joseph.Ingrassia@hhchealth.org
First Name & Middle Initial & Last Name & Degree
Jadwiga Jerman, MD
Phone
860-972-9146
Email
Jadwiga.Jerman@hhchealth.org
First Name & Middle Initial & Last Name & Degree
Joseph Ingrassia, MD
First Name & Middle Initial & Last Name & Degree
Mohamad Firas Barbour
Facility Name
Clearwater Cardiovascular Consultants
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Cameron, RN
Phone
727-467-9393
Email
cameronm@cccheart.com
First Name & Middle Initial & Last Name & Degree
Douglas Spriggs, MD
First Name & Middle Initial & Last Name & Degree
Donald Kikta, MD
Facility Name
Baptist Medical Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salil Patel, Dr.
Phone
904-202-7312
Email
BHRI@bmcjax.com
Facility Name
Orlando Health Heart & Vascular Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George M. Ngo, MSM
Phone
321-843-9657
Email
george.ngo@orlandohealth.com
First Name & Middle Initial & Last Name & Degree
Gloryvee Hernandez-Pagan, MSN
Phone
321-841-3686
Email
gloryvee.hernandezpagan@orlandohealth.com
First Name & Middle Initial & Last Name & Degree
Farhan J. Khawaja, MD
First Name & Middle Initial & Last Name & Degree
Maxim Olivier, MD
Facility Name
Piedmont Heart Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Kandzari, MD
Facility Name
Wellstar Research Institute
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Hill
Phone
470-793-5148
First Name & Middle Initial & Last Name & Degree
Donna Lahay
Phone
470-793-4065
First Name & Middle Initial & Last Name & Degree
Salvatore Mannino, MD
First Name & Middle Initial & Last Name & Degree
Amar Patel, MD
Facility Name
University of Chicago Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michaela K McSweeney, RN-BC
Phone
773-702-7308
Email
mmcsweeney@bsd.uchciago.edu
First Name & Middle Initial & Last Name & Degree
Cynthia Arevalo
Email
carevalo@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Sandeep Nathan, MD
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153-3328
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruce Lewis, MD
Phone
708-216-9447
First Name & Middle Initial & Last Name & Degree
Wendy Klein, RN
Phone
708-327-2761
Email
wklein@luc.edu
First Name & Middle Initial & Last Name & Degree
Bruce Lewis, MD
Facility Name
Heart Care Centers of Illinois
City
Palos Park
State/Province
Illinois
ZIP/Postal Code
60464
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ravi Ramana, MD
Facility Name
St. Vincents Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Individual Site Status
Recruiting
Facility Name
Mercy Medical Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266-8209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Young, RN
Phone
515-633-3841
Email
jyoung@iowaheart.com
First Name & Middle Initial & Last Name & Degree
Traci Sprague, RN
Phone
(515) 633-3847
Email
traci.sprague@commonspirit.org
First Name & Middle Initial & Last Name & Degree
Magdi Ghali, MD
First Name & Middle Initial & Last Name & Degree
Daniel Shivapour, MD
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Secemsky, MD
Phone
617-667-8800
First Name & Middle Initial & Last Name & Degree
Jenifer Kaufman
Phone
617-632-8956
First Name & Middle Initial & Last Name & Degree
Eric Secemsky, MD
First Name & Middle Initial & Last Name & Degree
Brett Carroll, MD
First Name & Middle Initial & Last Name & Degree
Anna Krawisz, MD
Facility Name
Ascension St. John Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renee Bess, CCRP
Phone
313-343-4811
Email
renee.bess@ascension.org
First Name & Middle Initial & Last Name & Degree
Rhonda Beauchemin, RN
Phone
313.343.7536
Email
rhonda.beauchemin@ascension.org
First Name & Middle Initial & Last Name & Degree
Amir Kaki, MD
First Name & Middle Initial & Last Name & Degree
Theodore Schreiber, MD
Facility Name
Spectrum Health Hospitals
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503-2560
Country
United States
Individual Site Status
Recruiting
Facility Name
Saint Joseph Mercy Oakland
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kiritkumar Patel
Facility Name
Ascension Providence Hospital
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yulia Abidov, RN, CCRC
Phone
248-849-5328
Email
yulia.abidov@ascension.org
First Name & Middle Initial & Last Name & Degree
Heather Hesano, RN, BSN
Phone
248-8492379
Email
heather.hesano@ascension.org
First Name & Middle Initial & Last Name & Degree
Shukri David, MD
Facility Name
Metropolitan Heart and Vascular Institute (MHVI)
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brittany Renier, RN, BSN
Phone
763-236-9134
Email
Brittany.Renier@mhvi.com
First Name & Middle Initial & Last Name & Degree
Derek Vang, MBSc, CCRC
Phone
763-236-9347
Email
derek.vang@mhvi.com
First Name & Middle Initial & Last Name & Degree
Matthew Whitbeck, MD
First Name & Middle Initial & Last Name & Degree
Daniel Dulas, MD
Facility Name
CentraCare Heart & Vascular Center
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303-1900
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Kobylinski, BSN
Phone
320-251-2700
Ext
58316
Email
kelly.kobylinski@centracare.com
First Name & Middle Initial & Last Name & Degree
Jennifer Humbert, RN
Phone
320-251-2700
Ext
57560
Email
humbertj@centracare.com
First Name & Middle Initial & Last Name & Degree
Jacob Dutcher, MD
First Name & Middle Initial & Last Name & Degree
Wade Schmidt, MD
First Name & Middle Initial & Last Name & Degree
Yaga Saine
Facility Name
North Mississippi Medical Center
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brittany Cook, RN
Phone
662-620-6835
Email
Brittany.cook@nmhs.net
First Name & Middle Initial & Last Name & Degree
Kristin Eads, RD, BSN
Phone
662-620-6875
Email
keads@nmhs.net
First Name & Middle Initial & Last Name & Degree
Barry Bertolet, MD
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dimitrios Karmpaliotis, MD
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mollie Machado
Phone
718-920-6509
Email
momachado@montefiore.org
First Name & Middle Initial & Last Name & Degree
Mohamed Latib, MD
First Name & Middle Initial & Last Name & Degree
Maday Gonzalez, MD
Facility Name
SJH Cardiology Associates
City
Liverpool
State/Province
New York
ZIP/Postal Code
13088
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura R. Mowers, MS, CCRP
Phone
315-234-4412
Email
laura.mowers@sjhcardiology.org
First Name & Middle Initial & Last Name & Degree
Ayman Iskander
Facility Name
Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021-9800
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pretti Singh, MS
Phone
212-746-2516
Email
prs4008@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Dmitriy Feldman, MD
Facility Name
The Lindner Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kasey Riffey, RN, BSN
Phone
513-585-1777
Email
kasey.riffey@thechristhospital.com
First Name & Middle Initial & Last Name & Degree
John Corl, MD
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph D. Campbell, MD
Phone
614-566-1250
Email
joseph.campbell2@ohiohealth.com
First Name & Middle Initial & Last Name & Degree
Joseph D. Campbell, MD
First Name & Middle Initial & Last Name & Degree
John A. Phillips, MD
Facility Name
Oklahoma Heart Hospital
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad Ghani
Facility Name
UPMC Harrisburg Hospital
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gretchen C Meise, RN BSN
Phone
717-920-4464
Email
meisegc@upmc.edu
First Name & Middle Initial & Last Name & Degree
Joanna L Miller, RN BSN
Phone
717 920 4463
Email
Millerjl30@upmc.edu
First Name & Middle Initial & Last Name & Degree
William Bachinsky
First Name & Middle Initial & Last Name & Degree
Cleon Hubbard
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rianne Delacruz
Phone
215-349-8001
Email
rianne.delacruz@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Debbie Cohen, MD
First Name & Middle Initial & Last Name & Degree
Taisei Kobayashi, MD
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramzi Khalil, MD
Phone
412-359-4025
First Name & Middle Initial & Last Name & Degree
Tracy Spirk
Phone
412-359-4025
First Name & Middle Initial & Last Name & Degree
Ramzi Khalil, MD
First Name & Middle Initial & Last Name & Degree
David Lasorda, MD
Facility Name
AnMed Health Medical Center
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Frankum, MSN, RN
Phone
864-512-8519
Email
melissa.frankum@anmedhealth.org
First Name & Middle Initial & Last Name & Degree
Sonya Bair
Phone
1-864-512-8733
Email
Sonya.bair@anmedhealth.org
First Name & Middle Initial & Last Name & Degree
Brent McLaurin, MD
Facility Name
Centennial Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul T. Dalecke, CCRC
Phone
615-329-7357
Email
Paul.dalecke@hcahealthcare.com
First Name & Middle Initial & Last Name & Degree
Drew Quillen, CCRC/CCRP
Phone
615-417-1035
Email
Cameron.quillen@hcahealthcare.com
First Name & Middle Initial & Last Name & Degree
Brian Jefferson, MD
First Name & Middle Initial & Last Name & Degree
Bryan Doherty, MD
Facility Name
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226-1316
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Stoler, MD
Facility Name
Baylor Scott & White The Heart Hospital Baylor Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Srinivasa Potluri, MD
Facility Name
Methodist Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aliseiya Garza, BS
Phone
210-449-5026
First Name & Middle Initial & Last Name & Degree
Maurene Cantu, RN
Phone
210-218-4950
First Name & Middle Initial & Last Name & Degree
Jorge Alvarez, MD
First Name & Middle Initial & Last Name & Degree
Abelardo Martinez-Rumayor, MD
First Name & Middle Initial & Last Name & Degree
Moises Bucay, MD
Facility Name
The University of Texas at Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Thornton, LVN, CCRC
Phone
903-510-7295
Email
kevin.thornton@uthet.com
First Name & Middle Initial & Last Name & Degree
Elizabeth Seal, CCRC
Phone
903-510-7291
Email
eseal@uthet.com
First Name & Middle Initial & Last Name & Degree
Frank Navetta, MD
First Name & Middle Initial & Last Name & Degree
Robert Smith, MD
Facility Name
University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rony Lahoud, MD
Phone
802-847-3734
First Name & Middle Initial & Last Name & Degree
Amy Henderson
Phone
802-847-4746
Email
amy.henderson@uvmhealth.org
First Name & Middle Initial & Last Name & Degree
Rony Lahoud, MD
First Name & Middle Initial & Last Name & Degree
Dauerman Harold, MD
Facility Name
UVA Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Parker, RN, CCRC
Phone
434-982-1058
First Name & Middle Initial & Last Name & Degree
Linda Bryceland, RN, CCRC
Phone
434-982-1058
First Name & Middle Initial & Last Name & Degree
Kanwar Singh
Facility Name
Providence Regional Medical Center Everett
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catalina Danila
Phone
425-258-7273
Email
mihaela.danila@providence.org
First Name & Middle Initial & Last Name & Degree
Dean Rocco
First Name & Middle Initial & Last Name & Degree
Mahesh Mulumudi, MD
First Name & Middle Initial & Last Name & Degree
Apurva Badheka, MD
Facility Name
Algemeen Stedelijk Ziekenhuis - R&D Hartziekten
City
Aalst
State/Province
Oost - Vlaanderen
ZIP/Postal Code
9300
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
An Roets
Phone
+32 53764175
Email
an.roets@asz.be
First Name & Middle Initial & Last Name & Degree
Lies DeHauwere
Phone
+32 53766735
Email
lies.dehauwre@asz.be
First Name & Middle Initial & Last Name & Degree
Michael Rosseel, MD
Facility Name
AZ Sint Jan Brugge-Oostende av
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan van der Heyden, Dr
Facility Name
Ziekenhuis Oost Limburg - Campus Sint-Jan
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Individual Site Status
Recruiting
Facility Name
University Hospital Ghent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pieter Vervaet, MSc
Email
pieter.vervaet@uzgent.be
First Name & Middle Initial & Last Name & Degree
Michaël Buysse
Email
michael.buysse@uzgent.be
First Name & Middle Initial & Last Name & Degree
Benny Drieghe
Facility Name
Chc Montlegia
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pieter-Jan Palmers
Phone
+3243554180
First Name & Middle Initial & Last Name & Degree
Pieter-Jan Palmers
Facility Name
Uniklinik Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
091318536207
First Name & Middle Initial & Last Name & Degree
Roland Schmieder, Prof.
Facility Name
Universitatsklinikum des Saarlandes
City
Homburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felix Mahfoud, MD
Facility Name
Herzzentrum Leipzig
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
+49341865-0
Email
info.herzzentrum@helios-gesundheit.de
Facility Name
Sana Kliniken Lübeck GmbH
City
Lübeck
ZIP/Postal Code
23560
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof. J. Weil
Email
joachim.weil@sana.de
First Name & Middle Initial & Last Name & Degree
Tolga Agdirlioglu
First Name & Middle Initial & Last Name & Degree
Prof. J. Weil
Facility Name
Zuyderland Medisch Centrum Heerlen
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Kleikers, Dr
Phone
0031(0)884597522
Email
rd-cardiology@zuyderland.nl
First Name & Middle Initial & Last Name & Degree
Koos Heijnen, RN
Phone
0031(0)884597522
Email
k.heijnen@zuyderland.nl
First Name & Middle Initial & Last Name & Degree
Saman Rasoul, Dr
Facility Name
Erasmus Universtiy Medical Center
City
Rotterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joost Daemen, MD, PhD
Phone
+31 10 70 393 07
Email
j.daemen@erasmusmc.nl
First Name & Middle Initial & Last Name & Degree
Joost Daemen, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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