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.
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.
Brief Title
SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
612.310.4529
Central Contact Email
kari.a.hendlin@medtronic.com
Completion Date
Completion Date Type
Estimated
Conditions
Hypertension
Vascular Diseases
Cardiovascular Diseases
Chronic Kidney Diseases
Diabetes Mellitus
Eligibility Criteria
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%
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%
Inclusion Criteria
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
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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05198674
Org Class
Industry
Org Full Name
Medtronic Vascular
Org Study Id
MDT20044RDN004
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
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)
Primary Outcomes
Outcome Description
The Primary endpoint of office Systolic Blood Pressure (SBP) change at 6 months will be assessed for all patients in the Main Study Cohort
Outcome Measure
The Primary endpoint of office Systolic Blood Pressure (SBP) change at 6 months.
Outcome Time Frame
6 months
Secondary Outcomes
Outcome Time Frame
From baseline to 3, 6, 12, 24, and 36 months post-procedure
Outcome Measure
Office Systolic Blood Pressure change
Outcome Time Frame
From baseline to 3, 6, 12, 24, and 36 months post-procedure
Outcome Measure
Home Blood Pressure change (Main Cohort Only)
Outcome Time Frame
From baseline to 3, 6, 12, 24, and 36 months post-procedure
Outcome Measure
Change in blood pressure as measured by 24-hour ABPM
Outcome Time Frame
From baseline to 3, 6, 12, 24, and 36 months post-procedure
Outcome Measure
Percent of subjects achieving blood pressure control as measured by OBP, HBP and ABPM
Outcome Time Frame
Procedure to 36 months post-procedure
Outcome Measure
Time subject's blood pressure is controlled
Outcome Time Frame
From baseline to 3, 6, 12, 24, and 36 months post-procedure
Outcome Measure
Change in number of anti-hypertensive medications taken from baseline
Outcome Time Frame
From baseline to 3, 6, 12, 24, and 36 months post-procedure
Outcome Measure
Change from baseline in EQ-5D quality of life score
Outcome Time Frame
From baseline to 3, 6, 12, 24, and 36 months post-procedure
Outcome Measure
Change from baseline in hypertension health status score
Outcome Time Frame
From baseline to 3, 6, 12, 24, and 36 months post-procedure
Outcome Measure
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
Outcome Time Frame
From baseline to 3, 6, 12, 24, and 36 months post-procedure
Outcome Measure
Evaluation of slope of eGFR
Outcome Time Frame
From baseline to 3, 6, 12, 24, and 36 months post-procedure
Outcome Measure
Incidence of events, including major adverse events
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Mohamed Azeem Latib
Investigator Email
mlatib@montefiore.org
Investigator Phone
646-773-2076