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A higher score means a better outcome.",{"measure":37,"description":20,"timeFrame":21},"Evaluate factors influencing blood pressure response to renal denervation",{"measure":39,"description":20,"timeFrame":21},"Evaluation of slope of eGFR",{"measure":41,"description":20,"timeFrame":21},"Incidence of safety events, including major adverse events",{"allocation":43,"interventionModel":44,"interventionModelDescription":20,"primaryPurpose":45,"observationalModel":20,"timePerspective":20,"maskingInfo":46},"NA","SINGLE_GROUP","TREATMENT",{"masking":47,"maskingDescription":20,"whoMasked":20},"NONE","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).\n\nSPYRAL SWYFT study is conducted under the overarching SPYRAL AFFIRM protocol (NCT05198674), focused on EU and APAC regions.",[50],{"label":51,"type":52,"description":53,"interventionNames":54},"SWYFT cohort","EXPERIMENTAL","Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)",[55],"Device: Symplicity Spyral™ multi-electrode renal denervation system",[57],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":62},"DEVICE","Symplicity Spyral™ multi-electrode renal denervation system","After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure.",[51],[63,64],"Renal Angiography","Renal Denervation",[66,70],{"name":67,"affiliation":68,"role":69},"David Lee, MD","Stanford University","PRINCIPAL_INVESTIGATOR",{"name":71,"affiliation":72,"role":69},"Konstantinos Tsioufis, Prof Dr","Hippokration General Hospital of Athens",[74,79],{"name":75,"role":76,"phone":77,"phoneExt":20,"email":78},"Kelsey Anderson","CONTACT","651 247 5268","rs.spyralaffirm@medtronic.com",{"name":80,"role":76,"phone":81,"phoneExt":20,"email":78},"Carly Loudoun","+31 43 356 6566",[83,99,111,127,140,152,165,178,195,211,223,236,248,262,274,289,305,320,334,350,361],{"facility":84,"status":85,"city":86,"state":20,"zip":20,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":94,"contacts":95},"The Alfred Hospital","RECRUITING","Melbourne","Australia","AU",{"type":90,"coordinates":91},"Point",[92,93],144.96332,-37.814,{"lat":93,"lon":92},[96,98],{"name":97,"role":76,"phone":20,"phoneExt":20,"email":20},"Tony Walton, MD",{"name":97,"role":69,"phone":20,"phoneExt":20,"email":20},{"facility":100,"status":85,"city":101,"state":20,"zip":20,"country":87,"countryCode":88,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Royal Perth Hospital","Perth",{"type":90,"coordinates":103},[104,105],115.8614,-31.95224,{"lat":105,"lon":104},[108,110],{"name":109,"role":76,"phone":20,"phoneExt":20,"email":20},"Markus Schlaich, MD",{"name":109,"role":69,"phone":20,"phoneExt":20,"email":20},{"facility":112,"status":85,"city":113,"state":114,"zip":115,"country":116,"countryCode":117,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Ziekenhuis Oost Limburg","Genk","Limburg","3600","Belgium","BE",{"type":90,"coordinates":119},[120,121],5.50082,50.965,{"lat":121,"lon":120},[124,126],{"name":125,"role":76,"phone":20,"phoneExt":20,"email":20},"Koen Ameloot, MD",{"name":125,"role":69,"phone":20,"phoneExt":20,"email":20},{"facility":128,"status":85,"city":129,"state":129,"zip":130,"country":116,"countryCode":117,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"CHC MontLégia","Liège","4000",{"type":90,"coordinates":132},[133,134],5.56749,50.63373,{"lat":134,"lon":133},[137,139],{"name":138,"role":76,"phone":20,"phoneExt":20,"email":20},"Pieter-Jan Palmers, MD",{"name":138,"role":69,"phone":20,"phoneExt":20,"email":20},{"facility":141,"status":85,"city":142,"state":20,"zip":20,"country":116,"countryCode":117,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Algemeen Stedelijk Ziekenhuis - 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John Radcliffe Hospital","Oxford","United Kingdom","UK",{"type":90,"coordinates":367},[368,369],-1.25596,51.75222,{"lat":369,"lon":368},[372,374],{"name":373,"role":76,"phone":20,"phoneExt":20,"email":20},"Giovanni Luigi De Maria, MD",{"name":375,"role":69,"phone":20,"phoneExt":20,"email":20},"Giovanni Luigi De Maria",{"type":377,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100601857","streamlined-denervation-with-spyral-for-an-optimized-treatment-spyral-swyft-in-subjects-with-uncontrolled-hypertension-100601857",false,"NCT07115953","Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension","Sub-study of SPYRAL AFFIRM: Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT)","SWYFT","Inclusion Criteria:\n\n1. Individual is diagnosed with hypertension and has a baseline office systolic blood pressure ≥140 mmHg\n2. Individual has a baseline office diastolic blood pressure ≥ 90 mmHg\n3. Individual has an average systolic baseline home blood pressure ≥135 mmHg (with ≥7 days of valid pre-procedure measurements)\n4. Individual has a valid 24-hour Ambulatory Blood Pressure Measurement at baseline\n\nExclusion Criteria:\n\n1. Individual lacks appropriate renal artery anatomy\n2. Individual has undergone prior renal denervation\n3. Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement\n4. Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea\n5. Individual has an estimated glomerular filtration rate (eGFR) of \\\u003C45 mL\u002Fmin\u002F1.73m2\n6. Individual has one or more episode(s) of orthostatic hypotension\n7. Individual is pregnant, nursing or planning to become pregnant\n8. Individual has documented primary pulmonary hypertension\n9. Individual has documented type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus with glycosylated hemoglobin greater than 8.0%","ALL","18 Years",{"count":389,"type":390},130,"ESTIMATED","INTERVENTIONAL",[43],"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.",[395,396,397,398,399],"Hypertension","Vascular Diseases","Cardiovascular Diseases","Chronic Kidney Diseases","Diabetes Mellitus","2026-06-29",{"date":402,"type":403},"2026-06-30","ACTUAL",{"date":405,"type":403},"2025-09-22",{"date":407,"type":390},"2029-12-31",{"name":5,"class":6},21]