[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Orchestra BioMed, Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":65},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100520674","bradycardia-pacemaker-with-av-interval-modulation-for-blood-pressure-treatment-100520674",false,"NCT06059638","BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT","BACKBEAT","Inclusion Criteria:\n\n1. Patient has or is indicated for a dual-chamber pacemaker. Visit 1 can be performed within 30 days prior to a planned implant of a Medtronic Astra\u002FAzure dual-chamber pacemaker system or at any time thereafter\n2. On a stable antihypertension treatment regimen with at least 1 class of antihypertensive drug\n3. Office SBP ≥135 mmHg and \\\u003C180 mmHg\n4. Average 24-Hour aSBP ≥130 mmHg and \\\u003C170 mmHg\n\nExclusion Criteria:\n\n1. LVEF \\\u003C50%\n2. NYHA Class III-IV\n3. History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months\n4. Myocardial infarction (MI) within 3 months\n5. Prior percutaneous or surgical coronary, carotid, or endovascular intervention within 3 months\n6. Permanent atrial fibrillation\n7. Mitral valve regurgitation greater than or equal to grade 3\n8. Aortic stenosis with a valve area less than 1.5 cm2\n9. Has an active or prior device-based anti-hypertensive treatment (e.g., renal denervation procedure, baroreflex activation therapy)\n10. Has an existing active cardiac device or neurostimulator other than the recent Astra\u002FAzure pacemaker implant","ALL","18 Years",{"count":19,"type":20},500,"ESTIMATED","INTERVENTIONAL",[23],"NA","A prospective, multinational, randomized, double-blind, clinical trial evaluating the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm downloaded into a dual-chamber Medtronic Astra\u002FAzure pacemaker.",[26,27,28],"Hypertension","Hypertension, Systolic","Hypertension, Essential","RECRUITING","2026-05-22",{"date":32,"type":33},"2026-05-27","ACTUAL",{"date":35,"type":33},"2023-12-27",{"date":37,"type":20},"2029-08",{"name":39,"class":40},"Orchestra BioMed, Inc","INDUSTRY",129,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":5},"100596418","virtue-sab-in-the-treatment-of-coronary-isr-trial-100596418","NCT07045194","Virtue® SAB in the Treatment of Coronary ISR Trial","A Prospective, Multi-center, Single-blind, Randomized (1:1), Non-inferiority Study Comparing Clinical Outcomes of the Virtue® Sirolimus AngioInfusion™ Balloon (SAB) to the AGENT™ Paclitaxel Drug-Coated Balloon (DCB) in the Treatment of Coronary Artery In-stent Restenosis (ISR).","Inclusion Criteria:\n\n* In-stent restenosis (one or two stent layers) in a lesion previously treated with drug- eluting (DES) or bare metal stents (BMS) in a native coronary artery.\n* The target lesion is in a vessel with a reference vessel diameter ≥ 2.0 mm and ≤ 4.0 mm by visual assessment.\n* The subject has only one critical ISR lesion.\n* The subject may have one other critical lesion in a non-target vessel that must be treated before the Target Lesion (TL).\n* Target lesion length must be ≤ 26 mm and must be completely coverable by only one Virtue® or AGENT™ balloon. The balloon can extend up to 5 mm proximal or distal beyond the edge of the target stented length.\n* The target lesion must have one of the following:\n* Visually estimated stenosis of ≥ 70% and \\\u003C100% diameter stenosis, OR\n* Visually estimated stenosis ≥ 50% and \\\u003C 70% with one of the following:\n* abnormal fractional flow reserve (FFR) including Angio based FFR ≤ 0.80, or;\n* abnormal instantaneous wave-free ratio (iFR) or resting full-cycle ratio (RFR) ≤ 0.89, or;\n* abnormal stress or imaging stress test, or;\n* ischemic symptoms referable to the target lesion\n* Involved in a NSTEMI or Acute Coronary Syndrome (ACS) event with decreasing enzymes\n* Target lesion must be successfully pre-treated according to standard of care with an achieved residual stenosis of ≤ 30% by visual estimate with TIMI grade flow of 3 prior to randomization.\n\nExclusion Criteria:\n\n* Subject has a left ventricular ejection fraction \\\u003C 30% within 6 months.\n* Subject was treated by PCI or another coronary intervention within the last 30 days.\n* Planned PCI or CABG after the index procedure.\n* Subjects with STEMI \\\u003C 72 hours prior to index procedure and those with NSTEMI who have increasing biomarkers within 12 hours of the index procedure.\n* If single-layer ISR, any previous treatment (other than balloon angioplasty alone) of the target vessel for restenosis. If double-layer ISR, any treatment (other than balloon angioplasty alone) of the double-layer ISR restenosis.\n* Target lesion is located within a saphenous vein graft or an arterial graft.\n* Thrombus is present in the target vessel.\n* \\> 50% stenosis of an additional lesion proximal or clinically significant distal (\\>2.0mm RVD) to the target lesion.\n* A dissection in the target lesion requiring treatment with a stent post pre-dilatation.\n* The target ISR lesion has more than two layers of previously placed stents.\n* Subject has critical unprotected left main coronary artery disease.",{"count":50,"type":20},740,[23],"A prospective, multi-center, single-blind, randomized (1:1), non-inferiority study comparing clinical outcomes of the Virtue® Sirolimus AngioInfusion™ Balloon (SAB) to the AGENT™ Paclitaxel Drug-Coated Balloon (DCB) in the treatment of coronary artery in-stent restenosis (ISR).",[54],"Coronary Artery Disease",[56],"In-Stent Restenosis","2025-10-27",{"date":59,"type":33},"2025-10-29",{"date":61,"type":33},"2025-10-20",{"date":63,"type":20},"2032-10",{"name":39,"class":40},""]