Sub-study of SPYRAL AFFIRM: Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 130
- Locations
- 24
- Primary Endpoint
- Procedure time
Study Overview
Brief Summary
The purpose of the SPYRAL SWYFT sub-study is to evaluate whether renal denervation with the Symplicity Spyral system performed in the main and first order branch renal arteries yields a shorter procedure time and is as effective in reducing blood pressure than the procedural approach used in the SPYRAL HTN-ON MED and SPYRAL PIVOTAL - SPYRAL HTN-OFF MED clinical studies in an uncontrolled hypertensive population.
Detailed Description
SPYRAL SWYFT will evaluate the long-term safety, efficacy, and durability of the Symplicity Spyral system to determine whether renal denervation performed in the main and first order branch renal arteries yields a shorter procedure time and is as effective in reducing blood pressure than the procedural approach used in the SPYRAL HTN-ON MED and SPYRAL PIVOTAL - SPYRAL HTN-OFF MED clinical studies (where all accessible renal arterial vessels between 3 and 8 mm in diameter including accessory, branch and main renal arteries (outside the kidney parenchyma) were targeted for ablation).
SPYRAL SWYFT study is conducted under the overarching SPYRAL AFFIRM protocol (NCT05198674), focused on EU and APAC regions.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Individual is diagnosed with hypertension and has a baseline office systolic blood pressure ≥140 mmHg
- •Individual has a baseline office diastolic blood pressure ≥ 90 mmHg
- •Individual has an average systolic baseline home blood pressure ≥135 mmHg (with ≥7 days of valid pre-procedure measurements)
- •Individual has a valid 24-hour Ambulatory Blood Pressure Measurement at baseline
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 <45 mL/min/1.73m2
- •Individual has one or more episode(s) of orthostatic hypotension
- •Individual is pregnant, nursing or planning to become pregnant
- •Individual has documented primary pulmonary hypertension
- •Individual has documented type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus with glycosylated hemoglobin greater than 8.0%
Arms & Interventions
SWYFT cohort
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
Intervention: Symplicity Spyral™ multi-electrode renal denervation system (Device)
Outcomes
Primary Outcomes
Procedure time
Time Frame: Procedure
Procedure time will be compared to the SPYRAL HTN-ON MED and SPYRAL PIVOTAL - SPYRAL HTN-OFF MED procedure times.
Office Systolic Blood Pressure Change
Time Frame: 6 months
Office Systolic Blood Pressure (OSBP) change from baseline to 6 months will be compared to the SPYRAL HTN-ON MED and SPYRAL PIVOTAL - SPYRAL HTN-OFF MED study efficacy endpoints using a propensity score stratified baseline blood pressure adjusted analysis at 3 months (OFF MED) and 6 months (ON MED).
Secondary Outcomes
- Office Systolic Blood Pressure change(From baseline to 3, 6, 12, 24, and 36 months post-procedure)
- Home Blood Pressure change(From baseline to 3, 6, 12, 24, and 36 months post-procedure)
- Change in blood pressure as measured by 24-hour ABPM(From baseline to 3, 6, 12, 24, and 36 months post-procedure)
- Percent of subjects achieving blood pressure control as measured by OBP, HBP and ABPM(From baseline to 3, 6, 12, 24, and 36 months post-procedure)
- Time subject's blood pressure is controlled(Procedure to 36 months post-procedure)
- Change in number of anti-hypertensive medications taken from baseline(From baseline to 3, 6, 12, 24, and 36 months post-procedure)
- Evaluate factors influencing blood pressure response to renal denervation(From baseline to 3, 6, 12, 24, and 36 months post-procedure)
- Evaluation of slope of eGFR(From baseline to 3, 6, 12, 24, and 36 months post-procedure)
- Incidence of safety events, including major adverse events(From baseline to 3, 6, 12, 24, and 36 months post-procedure)
- Office Systolic Blood Pressure change(From baseline to 3, 6, 12, 24, and 36 months post-procedure)
- Home Blood Pressure change(From baseline to 3, 6, 12, 24, and 36 months post-procedure)
- Change in blood pressure as measured by 24-hour ABPM(From baseline to 3, 6, 12, 24, and 36 months post-procedure)
- Percent of subjects achieving blood pressure control as measured by OBP, HBP and ABPM(From baseline to 3, 6, 12, 24, and 36 months post-procedure)
- Time subject's blood pressure is controlled(Procedure to 36 months post-procedure)
- Change in number of anti-hypertensive medications taken from baseline(From baseline to 3, 6, 12, 24, and 36 months post-procedure)
- Change from baseline in hypertension health status score(From baseline to 3, 6, 12, 24, and 36 months post-procedure. A higher score means a better outcome.)
- Evaluate factors influencing blood pressure response to renal denervation(From baseline to 3, 6, 12, 24, and 36 months post-procedure)
- Evaluation of slope of eGFR(From baseline to 3, 6, 12, 24, and 36 months post-procedure)
- Incidence of safety events, including major adverse events(From baseline to 3, 6, 12, 24, and 36 months post-procedure)