The SPYRAL AFFIRM Global Clinical Study of Renal Denervation with the Symplicity Spyral Renal Denervation System in Subjects with Uncontrolled Hypertension (SPYRAL AFFIRM)
- Conditions
- uncontrolled hypertension10057166
- Registration Number
- NL-OMON51861
- Lead Sponsor
- Medtronic B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
1) Individual is >=18 years of age at time of enrollment (consent)
2) Individual is diagnosed with hypertension and has an average baseline office
systolic blood pressure >=140 mmHg (measured per Appendix B)
3) >=7 days of valid pre-procedure HBP measurements within 30 days prior to the
procedure; consecutive days are preferred but not required (measured per
Section 9.5) Not applicable for the Continuation Cohort
4) Individual agrees to have all study procedures performed and is competent
and willing to provide documented informed consent to participate in this
clinical study. Continuation Cohort must again meet this criterion at time of
SPYRAL AFFIRM Consent
5) Individual was initially randomized to the treatment arm and successfully
underwent the RDN procedure, in either the SPYRAL-PIVOTAL- SPYRAL -HTN-OFF MED
or SPYRAL HTN-ON MED study. Continuation Cohort only
6) Individual has completed their 36- month visit and been exited from the
SPYRAL-PIVOTAL- SPYRAL-HTN OFF MED or SPYRAL HTN-ON MED study. Continuation
Cohort only
7) Individual has a baseline office diastolic blood pressure >=90 mmHg (measured
per Appendix B)
8) Individual has an average systolic baseline home blood pressure >=135 mmHg
(calculated using home blood pressure readings from the first 7 valid days
post-baseline).
1) Individual has renal artery anatomy that is ineligible for treatment
including:
a) At least one main renal artery with a diameter of less than 3 mm or greater
than 8 mm
b) Lacks a main renal arterial vessel that does not allow 4 simultaneous
quadrantic (4SQ) radio frequency ablations in the main renal artery or
equivalent (defined as 4SQ ablations in all branch vessels between 3mm and 8mm)
2) Individual has >50% stenosis in any treatable vessels.
3) Individual has a treatment area within 5mm of a segment in the renal artery
which contains any of the following:
a) Atheroma
b) Calcification, or
c) Renal artery stent
4) Individual has a renal artery stent placed <3 months prior to procedure
5) Individual has undergone prior renal denervation
6) Presence of fibromuscular dysplasia (FMD) (defined as visible beading of the
artery on angiography)
7) Individual has untreated secondary cause of hypertension (either known or
suspected). Secondary cause does not include obstructive sleep apnea
8) Individual has a documented condition that would prohibit or interfere with
ability to obtain an accurate blood pressure measurement using the
protocol-specified blood pressure monitors (e.g., upper arm circumference
outside cuff size ranges or arrhythmia that interferes with monitor*s pulse
sensing or prohibits an accurate measurement) Continuation Cohort must not meet
this criterion again at time of SPYRAL AFFIRM Consent.
9) Individual has a documented confounding medical condition, which in the
opinion of the investigator, may adversely affect the safety of the participant
(e.g., individuals with clinically significant peripheral vascular disease, or
aortic aneurysm)
10) Individual requires chronic oxygen support or mechanical ventilation other
than nocturnal respiratory support for sleep apnea (e.g. CPAP, BiPAP)
11) Individual has an estimated glomerular filtration rate (eGFR) of <45
mL/min/1.73m2, using the 4 variable MDRD calculation (in mL/min per 1.73m2 =
175 x SerumCr -1.154 x Age -0.203 x 1.212 (if subject is of African descent) x
0.742 (if subject is female).
12) Individual has had >= 1 episode(s) of orthostatic hypotension not related to
medication changes within the past year or has a reduction of SBP of >= 20 mmHg
or DBP of >=10 mmHg within 3 minutes of standing coupled with symptoms during
the screening process
13) Individual is pregnant, nursing or planning to become pregnant during the
study. (Note: Pre-menopausal participants must have a negative serum or urine
human chorionic gonadotropin (hCG) pregnancy test prior to angiography)
Continuation Cohort must not meet this criterion again at time of SPYRAL AFFIRM
Consent
14) Individual has polycystic kidney disease, unilateral kidney, atrophic
kidney, or history of renal transplant
15) Individual has a history of narcotic drug abuse or is currently on
Methadone, and would be unlikely or unable, in the opinion of the investigator,
to comply with study follow-up requirements
16) Individual has a history of bleeding diathesis (bleeding disorders such as
thrombocytopenia, hemophilia, significant anemia, or evidence of autonomic
dysfunction where imbalance of sympathetic and parasympathetic tone may alter
disease process in an unpredictable manner) or coagulopathy or will refuse
blood transfusions<b
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The Primary endpoint of office Systolic Blood Pressure (SBP) change at 6 months<br /><br>will be assessed for all patients in the Main Study Cohort. In addition,<br /><br>comparison to a pre-specified performance goal for subjects treated in the US<br /><br>will be performed.<br /><br>Key objectives related to RDN efficacy, safety, and durability in the full<br /><br>population and in multiple subgroups will be presented</p><br>
- Secondary Outcome Measures
Name Time Method