{ "data": { "asOf": "2026-10-30T22:25:24.939Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT07806149", "title": "NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices", "scientificTitle": "NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices", "status": "not_yet_recruiting", "studyType": "interventional", "phase": [], "conditions": [ "Hypertrophic Cardiomyopathy", "Left Ventricular Outflow Obstruction", "Systolic Anterior Motion" ], "interventions": [ { "name": "SESAME Procedure", "type": "DEVICE", "description": "The intervention is the SESAME procedure, a catheter-based septal myotomy performed in adults with symptomatic or high-risk LVOT obstruction. It uses off-label Astato XS 20/40 guidewires and the NHLBI LCI electrosurgery timing appliance to create a controlled longitudinal laceration through the hypertrophied interventricular septum under fluoroscopic and echocardiographic guidance, with energy delivery limited to short pulses and cooling intervals to reduce thermal injury; all participants receive the same procedure, with follow-up assessments afterward." } ], "sponsor": { "name": "National Heart, Lung, and Blood Institute (NHLBI)", "type": "NIH" }, "locations": [ { "city": "Washington D.C.", "country": "United States", "facility": "MedStar Washington Hospital Center" }, { "city": "Atlanta", "country": "United States", "facility": "Emory University Hospital" }, { "city": "Boston", "country": "United States", "facility": "Beth Israel Deaconess Medical Center" }, { "city": "Roslyn", "country": "United States", "facility": "St. Francis Hospital & Heart Center" }, { "city": "The Bronx", "country": "United States", "facility": "Montefiore Medical Center: Einstein Campus" }, { "city": "York", "country": "United States", "facility": "WellSpan York Hospital" }, { "city": "Charlottesville", "country": "United States", "facility": "Univ. of Virginia" }, { "city": "Roanoke", "country": "United States", "facility": "Carilion Roanoke Memorial Hospital" } ], "outcomes": { "other": [], "primary": [ "SESAME Technical Success", "SESAME Safety" ], "secondary": [] }, "eligibility": { "sex": "ALL", "criteria": "* INCLUSION CRITERIA\n* Adults age \\>= 21 years\n* Requires left ventricular septal reduction therapy for one of two indications\n\n 1. Obstructive hypertrophic cardiomyopathy with symptomatic left ventricular outflow tract obstruction (30mmHg peak while resting OR 50mmHg peak when provoked); OR\n 2. Planned transcatheter mitral valve replacement is feasible but limited by risk for iatrogenic left ventricular outflow tract obstruction, defined on contrast-enhanced CT as skirt-neo-LVOT \\<200\\^2\n* Planning to undergo SESAME transcatheter myotomy\n* Septal diastolic thickness on CT as measured by the NHLBI central laboratory before enrollment:\n\n * For obstructive hypertrophic cardiomyopathy, \\>=14mm;\n * For transcatheter heart valve replacement, \\>=12mm\n\nand\n\n* Intended minimum diastolic residual septal thickness \\>=6mm\n\n -Severely symptomatic, any of\n* NYHA Class III or greater\n* Canadian Angina Class CCS III or greater\n\n * Explicitly chooses investigational SESAME over conventional treatment approaches including\n\n 1. cardiac myosin inhibitor therapy, if eligible (obstructive HCM only);\n 2. transcoronary alcohol septal ablation, if eligible; or\n 3. surgical left ventricular myotomy and/or myectomy, if eligible\n * Concurrence of the multidisciplinary institutional heart team that the candidate is at high risk for surgical myectomy and that SESAME is an appropriate septal reduction strategy for this candidate.\n * Willing to return for all scheduled follow-up activities, and eligible or able to undergo required protocol and testing\n\nEXCLUSION CRITERIA\n\n* Does not consent to participate, or unable to consent to participate\n* Pregnant\n* Hemodynamic instability or emergency procedure\n* Mechanical aortic valve\n* eGFR \\< 30 mL/min/1.73m\\^2", "maximumAge": "100 Years", "minimumAge": "21 Years", "healthyVolunteers": false }, "enrollment": { "type": "ESTIMATED", "count": 200 }, "startDate": "2026-11-01", "completionDate": "2030-03-01", "lastUpdated": "2026-10-27T00:00:00.000Z", "firstPosted": "2026-09-08T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT07806149" ] }, "identifiers": [ { "idType": "nct", "idValue": "NCT07806149", "declaredBy": "clinicaltrials_gov" } ], "sourceRecords": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07806149", "sourceUrl": "https://clinicaltrials.gov/study/NCT07806149", "sourceStatus": "NOT_YET_RECRUITING", "retrievedAt": "2026-10-28T04:32:12.776Z", "payloadSha256": "a90e28a8865d3a4aca38d30fc0e6949ddc2446f0cd81e3554bd9925d71136664", "piiRedacted": true } ], "citation": { "canonicalId": "NCT07806149", "sources": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07806149", "verifyAt": "https://clinicaltrials.gov/study/NCT07806149", "retrievedAt": "2026-10-28T04:32:12.776Z", "payloadSha256": "a90e28a8865d3a4aca38d30fc0e6949ddc2446f0cd81e3554bd9925d71136664", "text": "ClinicalTrials.gov, record NCT07806149 (https://clinicaltrials.gov/study/NCT07806149), retrieved 2026-10-28, licence: public-domain." } ], "crossRegistry": false, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "text": "Trial NCT07806149, registered in ClinicalTrials.gov, retrieved 2026-10-28. 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