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

Hypertension Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05198674
• Other study ID #: MDT20044RDN004
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2021
• Est. completion date: November 30, 2029

Study information

• Verified date: April 2024
• Source: Medtronic Vascular
• Contact: Kelsey Anderson
• Phone: +17635149730
• Email: kelsey.m.anderson[@]medtronic.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: November 30, 2029
• Est. primary completion date: November 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Chronic Kidney Diseases
• Diabetes Mellitus
• Hypertension
• Kidney Diseases
• Renal Insufficiency, Chronic
• Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Dobney Hypertension Centre	Perth	Western Australia
Belgium	Algemeen Stedelijk Ziekenhuis - R&D Hartziekten	Aalst	Oost - Vlaanderen
Belgium	AZ Sint Jan Brugge-Oostende av	Brugge
Belgium	Ziekenhuis Oost Limburg - Campus Sint-Jan	Genk
Belgium	University Hospital Ghent	Gent
Belgium	Chc Montlegia	Liège
France	Hôpital Saint André -Centre Hospitalier Universitaire de Bordeaux	Bordeaux
France	Hôpital Pitié Salpêtrière	Paris
Germany	Uniklinik Erlangen	Erlangen
Germany	Justus-Liebig-Universität Gießen	Gießen
Germany	Universitatsklinikum des Saarlandes	Homburg
Germany	Herzzentrum Leipzig	Leipzig
Germany	Sana Kliniken Lübeck GmbH	Lübeck
Greece	Hippokration General Hospital of Athens	Athens
Monaco	Centre Hospitalier Princesse Grace	Monaco
Netherlands	Zuyderland Medisch Centrum Heerlen	Heerlen
Netherlands	Erasmus Universtiy Medical Center	Rotterdam
Sweden	Danderyd Sjukhus	Stockholm
United Kingdom	John Radcliffe Hospital	Oxford	Oxfordshire
United States	AnMed Health Medical Center	Anderson	South Carolina
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	University of Alabama at Birmingham (UAB) Hospital	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	University of Vermont Medical Center	Burlington	Vermont
United States	UVA Medical Center	Charlottesville	Virginia
United States	University of Chicago Medicine	Chicago	Illinois
United States	The Lindner Center	Cincinnati	Ohio
United States	BayCare Health System	Clearwater	Florida
United States	Clearwater Cardiovascular Consultants	Clearwater	Florida
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	Metropolitan Heart and Vascular Institute (MHVI)	Coon Rapids	Minnesota
United States	Baylor Jack and Jane Hamilton Heart and Vascular Hospital	Dallas	Texas
United States	Ascension St. John Hospital	Detroit	Michigan
United States	Providence Regional Medical Center Everett	Everett	Washington
United States	Spectrum Health Hospitals	Grand Rapids	Michigan
United States	UPMC Harrisburg Hospital	Harrisburg	Pennsylvania
United States	Hartford Hospital	Hartford	Connecticut
United States	Houston Methodist	Houston	Texas
United States	St. Vincents Hospital	Indianapolis	Indiana
United States	Baptist Medical Center	Jacksonville	Florida
United States	Scripps Memorial Hospital	La Jolla	California
United States	Arkansas Cardiology	Little Rock	Arkansas
United States	SJH Cardiology Associates	Liverpool	New York
United States	North Shore University Hospital	Manhasset	New York
United States	Wellstar Research Institute	Marietta	Georgia
United States	Loyola University Medical Center	Maywood	Illinois
United States	Banner Heart Hospital	Mesa	Arizona
United States	Advocate Aurora Health-Aurora St. Luke's Medical Center (ASLMC)	Milwaukee	Wisconsin
United States	Morristown Medical Center	Morristown	New Jersey
United States	Intermountain Medical Center	Murray	Utah
United States	Centennial Medical Center	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Weill Cornell Medical Center	New York	New York
United States	Oklahoma Heart Hospital	Oklahoma City	Oklahoma
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	AdventHealth Orlando	Orlando	Florida
United States	Orlando Health Heart & Vascular Institute	Orlando	Florida
United States	Heart Care Centers of Illinois	Palos Park	Illinois
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Abrazo Arizona Heart Hospital/Biltmore Cardiology	Phoenix	Arizona
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Baylor Scott & White The Heart Hospital Baylor Plano	Plano	Texas
United States	Saint Joseph Mercy Oakland	Pontiac	Michigan
United States	Rhode Island Hospital and Health Services	Providence	Rhode Island
United States	BayCare Medical Group	Safety Harbor	Florida
United States	CentraCare Heart & Vascular Center	Saint Cloud	Minnesota
United States	Methodist Hospital	San Antonio	Texas
United States	HonorHealth Research Institute	Scottsdale	Arizona
United States	Ascension Providence Hospital	Southfield	Michigan
United States	Stanford Hospital and Clinics	Stanford	California
United States	Tallahassee Memorial Healthcare, Inc	Tallahassee	Florida
United States	UM St. Joseph Medical Center	Towson	Maryland
United States	North Mississippi Medical Center	Tupelo	Mississippi
United States	The University of Texas at Tyler	Tyler	Texas
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	Mercy Medical Center	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Vascular

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  France,  Germany,  Greece,  Monaco,  Netherlands,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Primary endpoint of office Systolic Blood Pressure (SBP) change at 6 months.	The Primary endpoint of office Systolic Blood Pressure (SBP) change at 6 months will be assessed for all patients in the Main Study Cohort	6 months
Secondary	Office Systolic Blood Pressure change		From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
Secondary	Home Blood Pressure change (Main Cohort Only)		From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
Secondary	Change in blood pressure as measured by 24-hour ABPM		From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
Secondary	Percent of subjects achieving blood pressure control as measured by OBP, HBP and ABPM		From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
Secondary	Time subject's blood pressure is controlled		Procedure to 36 months post-procedure
Secondary	Change in number of anti-hypertensive medications taken from baseline		From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
Secondary	Change from baseline in EQ-5D quality of life score		From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
Secondary	Change from baseline in hypertension health status score		From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
Secondary	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		From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
Secondary	Evaluation of slope of eGFR		From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
Secondary	Incidence of events, including major adverse events		From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure