Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05198674




Registration number
NCT05198674
Ethics application status
Date submitted
5/11/2021
Date registered
20/01/2022
Date last updated
10/06/2024

Titles & IDs
Public title
SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN
Scientific title
The SPYRAL AFFIRM Global Clinical Study of Renal Denervation With the Symplicity Spyral Renal Denervation System in Subjects With Uncontrolled Hypertension (SPYRAL AFFIRM)
Secondary ID [1] 0 0
MDT20044RDN004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 0 0
Vascular Diseases 0 0
Cardiovascular Diseases 0 0
Chronic Kidney Diseases 0 0
Diabetes Mellitus 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Cardiovascular 0 0 0 0
Hypertension
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Renal Denervation (Symplicity Spyral™)

Experimental: Main Cohort: Renal Denervation - Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)


Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Primary endpoint of office Systolic Blood Pressure (SBP) change at 6 months.
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Office Systolic Blood Pressure change
Timepoint [1] 0 0
From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
Secondary outcome [2] 0 0
Home Blood Pressure change (Main Cohort Only)
Timepoint [2] 0 0
From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
Secondary outcome [3] 0 0
Change in blood pressure as measured by 24-hour ABPM
Timepoint [3] 0 0
From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
Secondary outcome [4] 0 0
Percent of subjects achieving blood pressure control as measured by OBP, HBP and ABPM
Timepoint [4] 0 0
From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
Secondary outcome [5] 0 0
Time subject's blood pressure is controlled
Timepoint [5] 0 0
Procedure to 36 months post-procedure
Secondary outcome [6] 0 0
Change in number of anti-hypertensive medications taken from baseline
Timepoint [6] 0 0
From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
Secondary outcome [7] 0 0
Change from baseline in EQ-5D quality of life score
Timepoint [7] 0 0
From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
Secondary outcome [8] 0 0
Change from baseline in hypertension health status score
Timepoint [8] 0 0
From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
Secondary outcome [10] 0 0
Evaluation of slope of eGFR
Timepoint [10] 0 0
From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure
Secondary outcome [11] 0 0
Incidence of events, including major adverse events
Timepoint [11] 0 0
From baseline to 1, 3, 6, 12, 24, and 36 months post-procedure

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/11/2029
Actual
Sample size
Target
1400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [2] 0 0
Dobney Hypertension Centre - Perth
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment postcode(s) [2] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
District of Columbia
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
Country [9] 0 0
United States of America
State/province [9] 0 0
Georgia
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Indiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Iowa
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Minnesota
Country [16] 0 0
United States of America
State/province [16] 0 0
Mississippi
Country [17] 0 0
United States of America
State/province [17] 0 0
Nebraska
Country [18] 0 0
United States of America
State/province [18] 0 0
New Jersey
Country [19] 0 0
United States of America
State/province [19] 0 0
New York
Country [20] 0 0
United States of America
State/province [20] 0 0
Ohio
Country [21] 0 0
United States of America
State/province [21] 0 0
Oklahoma
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
Rhode Island
Country [24] 0 0
United States of America
State/province [24] 0 0
South Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
Tennessee
Country [26] 0 0
United States of America
State/province [26] 0 0
Texas
Country [27] 0 0
United States of America
State/province [27] 0 0
Utah
Country [28] 0 0
United States of America
State/province [28] 0 0
Vermont
Country [29] 0 0
United States of America
State/province [29] 0 0
Virginia
Country [30] 0 0
United States of America
State/province [30] 0 0
Washington
Country [31] 0 0
United States of America
State/province [31] 0 0
West Virginia
Country [32] 0 0
United States of America
State/province [32] 0 0
Wisconsin
Country [33] 0 0
Belgium
State/province [33] 0 0
Oost - Vlaanderen
Country [34] 0 0
Belgium
State/province [34] 0 0
Brugge
Country [35] 0 0
Belgium
State/province [35] 0 0
Genk
Country [36] 0 0
Belgium
State/province [36] 0 0
Gent
Country [37] 0 0
Belgium
State/province [37] 0 0
Liège
Country [38] 0 0
France
State/province [38] 0 0
Bordeaux
Country [39] 0 0
France
State/province [39] 0 0
Paris
Country [40] 0 0
Germany
State/province [40] 0 0
Erlangen
Country [41] 0 0
Germany
State/province [41] 0 0
Gießen
Country [42] 0 0
Germany
State/province [42] 0 0
Homburg
Country [43] 0 0
Germany
State/province [43] 0 0
Leipzig
Country [44] 0 0
Germany
State/province [44] 0 0
Lübeck
Country [45] 0 0
Greece
State/province [45] 0 0
Athens
Country [46] 0 0
Monaco
State/province [46] 0 0
Monaco
Country [47] 0 0
Netherlands
State/province [47] 0 0
Heerlen
Country [48] 0 0
Netherlands
State/province [48] 0 0
Rotterdam
Country [49] 0 0
Sweden
State/province [49] 0 0
Stockholm
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Oxfordshire

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medtronic Vascular
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05198674
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Kandzari, MD
Address 0 0
Piedmont Heart Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kelsey Anderson
Address 0 0
Country 0 0
Phone 0 0
+17635149730
Fax 0 0
Email 0 0
kelsey.m.anderson@medtronic.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05198674