[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Zoll Medical Corporation\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":113},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,67,92],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100639895","remote-monitoring-and-optimization-of-heart-failure-therapy-100639895",false,"NCT07622472","Remote Monitoring and Optimization of Heart Failure Therapy","REMODEL-HF","Inclusion Criteria:\n\n* Age ≥18 years\n* Ability and willingness to provide written informed consent and comply with study procedures\n* Hospital admission for acute heart failure with dyspnea at rest and pulmonary congestion on chest X-ray, and other signs and\u002For symptoms of heart failure such as edema and\u002For positive rales on auscultation.\n* All measures within 24 hours prior to randomization of systolic blood pressure ≥ 100 mmHg, and of heart rate ≥ 60 bpm.\n* All measures within 24 hours prior to randomization of serum potassium ≤ 5.5 mEq\u002FL (mmol\u002FL).\n* Biomarker criteria for persistent congestion:\n\n  * NT-proBNP \\>1500 pg\u002FmL at the time of admission, and;\n  * NT-proBNP \\>1000 pg\u002FmL \\>=3 days after initial admission measure\n* At 1 week prior to admission, either (a) ≤ ½ the optimal dose of ACEi\u002FARB\u002FARNi (see Table) prescribed, no beta-blocker prescribed, and ≤ ½ the optimal dose of MRA prescribed or (b) no ACEi\u002FARB\u002FARNi prescribed, ≤ ½ the optimal dose of beta-blocker prescribed, and ≤ ½ the optimal dose of MRA prescribed. All study participants prescribed per label and commercially fit with the HFMS device will be eligible for enrollment.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Clearly documented intolerance to high doses (≥50% of target dose) of beta-blockers.\n* Clearly documented intolerance to high doses (≥50% of target dose) of RAS blockers (both ACEi and ARB).\n* Mechanical ventilation (not including CPAP\u002FBIPAP) in the 24 hours prior to Screening.\n* Significant pulmonary disease contributing substantially to the patients' dyspnea such as FEV1\\\u003C 1 liter or need for chronic systemic or nonsystemic steroid therapy, or any kind of primary right heart failure such as precapillary pulmonary hypertension or chronic thromboembolic pulmonary hypertension.\n* Cardiac surgery within 3 months prior to Screening\n* Index Event (admission for AHF) triggered primarily by a correctable etiology such as significant arrhythmia (e.g., sustained ventricular tachycardia, or atrial fibrillation\u002Fflutter with sustained ventricular response \\>130 beats per minute, or bradycardia with sustained ventricular arrhythmia \\\u003C45 beats per minute), severe anemia, acute coronary syndrome, pulmonary embolism, planned admission for device implantation or severe nonadherence leading to very significant fluid accumulation prior to admission and brisk diuresis after admission. Troponin elevations without other evidence of an acute coronary syndrome are not excluded.\n* Uncorrected thyroid disease, active myocarditis, or known amyloid, sarcoidosis, or hypertrophic obstructive cardiomyopathy.\n* History of heart transplant or on a transplant list, or using or planned to be implanted with a ventricular assist device.\n* Adhesive allergy\u002Fsensitivity (e.g., acrylic adhesives).\n* Compromised skin at the device application site (wound, severe dermatitis, etc.) .\n* Having a prescribed wearable cardioverter defibrillator\n* Pulmonary artery pressure implant (e.g. CardioMems)\n* Expected survival \\\u003C1 year","ALL","18 Years","85 Years",{"count":20,"type":21},800,"ESTIMATED","INTERVENTIONAL",[24],"NA","Heart failure is a condition in which the heart cannot pump blood effectively, often leading to symptoms such as shortness of breath and fluid retention. After hospitalization for heart failure, patients remain at high risk of worsening symptoms, emergency visits, and hospital readmission.\n\nThis study is designed to evaluate whether using a wearable monitoring device, called the Heart Failure Management System (HFMS), can help improve the management of patients after a recent hospitalization for heart failure.\n\nParticipants in this study will be randomly assigned to one of two groups. One group will receive standard medical care alone. The other group will receive standard medical care in combination with the HFMS device. The HFMS device is worn on the body and continuously collects information such as heart rate, breathing, activity level, and signs of fluid accumulation. These data are reviewed by the clinical care team and may help detect early worsening of heart failure.\n\nParticipants will wear the device for 90 days (if assigned to the device group) and will be followed for up to one year. During the study, information will be collected on serious health events such as death, hospitalizations, emergency visits, and changes in heart failure status, as well as quality of life.\n\nThe goal of this study is to determine whether this monitoring approach can improve outcomes for patients with heart failure by enabling earlier and more effective clinical management.",[27],"Heart Failure",[29],"Heart Failure, Remote Monitoring, Wearable Device","NOT_YET_RECRUITING","2026-06-25",{"date":33,"type":34},"2026-06-26","ACTUAL",{"date":36,"type":21},"2026-10-01",{"date":38,"type":21},"2029-08-01",{"name":40,"class":41},"Zoll Medical Corporation","INDUSTRY",9,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100558866","janus-ii-feasibility-100558866","NCT06556693","Janus II Feasibility","Janus II: A Feasibility Study to Evaluate Response to Remede Dual Channel System Therapy","Inclusion Criteria:\n\n* Severe sleep disordered breathing\n* Expected to tolerate study procedures\n* No heart failure or medically stable heart failure\n\nExclusion Criteria:\n\n* Currently implanted with a neurostimulator to treat sleep disordered breathing without sponsor approval\n* History of severe COPD or pulmonary arterial hypertension\n* Current or previous history of nerve injury or palsy\n* Prior cervical surgeries or radiation treatment to head region\n* Known need for an MRI\n* History of psychosis or severe bipolar disorder\n* Active Infection or sepsis within 30 days of enrollment\n* Currently on kidney dialysis or significantly reduced kidney function\n* Hemoglobin less than 8g\u002Fdl\n* Pacemaker dependance\n* New defibrillator or any implantable device or device generator changeout within 30 days prior to study implant or anticipated within the first 12 months\n* Other conditions or anticipated surgical procedure expected to affect ability to complete study procedures\n* Allergy to contrast dye unless can be prophylactically treated\n* Known pregnancy or planning to become pregnant","22 Years",{"count":52,"type":21},40,[24],"The objectives of this study are to evaluate the feasibility of the remedē® Dual Channel System at implant and overnight sleep studies and to assess chronic safety.",[56],"Sleep Apnea","RECRUITING","2025-10-28",{"date":60,"type":34},"2025-10-29",{"date":62,"type":34},"2025-08-12",{"date":64,"type":21},"2034-12",{"name":40,"class":41},3,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":76,"studyType":77,"phases":4,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":5},"100559958","prospective-wcd-post-cabg-registry-cabg-registry-100559958","NCT06570902","Prospective WCD Post CABG Registry (CABG Registry)","Prospective WCD Post CABG Registry","Inclusion Criteria\n\n* Patient underwent first-time CABG surgery \\\u003C10 days before enrollment.\n* Patient is prescribed WCD for a primary reason of HF with reduced EF \\\u003C 35% measured after surgery but before hospital discharge.\n* Patient is ≥18 years old\n\nExclusion Criteria:\n\n* Patients having combination CABG surgery with heart valve repair.\n* Patients with prior CABG.\n* Patients who have an active unipolar pacemaker.\n* Patients with a physical or mental condition that could impair their ability to properly interact with the WCD.\n\nPatients currently participating in an interventional clinical study. Patients with any skin condition that would prevent wearing the device. Patients with an advanced directive prohibiting resuscitation.",{"count":75,"type":21},910,"12 Months","OBSERVATIONAL","The primary objective is to observe the rate of recovery of ventricular function (EF\\>35%) after first-time coronary artery bypass graft surgery in patients who were prescribed the wearable cardioverter defibrillator (WCD) post-surgery prior to being discharged after hospitalization as part of standard clinical care.",[80,81,82,83],"Cardiomyopathy Ischemic","Cardiomyopathies","Cardiovascular Diseases","Heart Disease, Ischemic","2024-10-31",{"date":86,"type":34},"2024-11-04",{"date":88,"type":34},"2024-09-23",{"date":90,"type":21},"2030-05",{"name":40,"class":41},{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":99,"minAge":17,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":102,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":5},"100401203","optimizing-beta-blocker-dosage-in-women-while-using-the-wearable-cardioverter-defibrillator-100401203","NCT04504188","Optimizing Beta Blocker Dosage in Women While Using the Wearable Cardioverter Defibrillator","OPT-BB WOMEN","Inclusion Criteria for Screening Phase:\n\n* Female patients with newly diagnosed (never hospitalized for HF in the last 30 days prior to enrollment) ischemic or non-ischemic cardiomyopathy and an EF ≤ 35% at the time of WCD prescription.\n* Patients prescribed the WCD for an intended 90 ± 14 days of use.\n* Patients have used the WCD for no more than 14 days from the day of consent.\n* Patients 18 years of age or older at the time of consent.\n\nInclusion Criteria for Continuation Phase:\n\n-After the first 2 weeks of WCD wear, only actively wearing patients averaging at least 105 hours of WCD wear per week (or 15 hours\u002Fday) are eligible to continue.\n\nExclusion Criteria for Screening Phase:\n\n* Patients with a known contraindication or intolerance to beta-blocker therapy.\n* Patients with permanent atrial fibrillation.\n* Patients who have a pacemaker.\n* Patients with a current or prior implantable cardioverter defibrillator (ICD).\n* Patients who are self-reporting to be pregnant.\n* Patients with known congenital or inherited heart disease.\n* Patients participating in another interventional clinical trial.\n* Patients not expected to live longer than 3 months.\n\nExclusion Criteria for Continuation Phase:\n\n-Patients ending WCD use within the first two weeks of use.","FEMALE",{"count":101,"type":21},300,[24],"The primary objective of this pilot study is to document the percentage achievement in effective HR control (average nighttime HR \\\u003C 70 bpm) during WCD use in a cohort of female patients with cardiomyopathy in an outpatient setting using continuous heart rate (HR) trends data from the WCD to optimize BB\u002Fivabradine dosage, as compared to a prior historical control.",[81,27],"2024-07-23",{"date":107,"type":34},"2024-07-24",{"date":109,"type":34},"2021-03-08",{"date":111,"type":21},"2024-12",{"name":40,"class":41},""]