[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University Medical Center Mainz\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":100},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,69],{"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":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100651217","achieving-optimal-medical-therapy-through-percutaneous-treatment-of-secondary-mitral-regurgitation-to-improve-outcome-in-patients-with-hfref-100651217",false,"NCT07758023","Achieving Optimal Medical Therapy Through Percutaneous Treatment of Secondary Mitral Regurgitation to Improve Outcome in Patients With HFrEF","ACHILLES-HF","Inclusion Criteria:\n\n1. Heart failure with reduced ejection fraction (HFrEF, left ventricular ejection fraction ≤40%)\n2. Clinically significant functional mitral regurgitation (moderate-to severe or severe MR) as defined by European Association of Echocardiography, within 90 days prior to randomization (i.e. EROA ≥0.2 cm² and\u002For regurgitant fraction \\>30%)\n3. Suboptimal GDMT therapy corresponding to a GDMT score \\\u003C7 points\n4. Risk factor for not intensification of guideline directed medical therapy (at least one of the following):\n\n   1. Office systolic blood pressure \\\u003C120 mmHG\n   2. Chronic renal failure with eGFR \\\u003C60 ml\u002Fmin\u002F1.73m\n   3. History of acute kidney injury (AKI) at least stage 2 within the last 12 months\n   4. Serum Potassium ≥ 4.8 mmol\u002FL\n5. Persisting symptoms equalling NYHA functional class II-IVa (ambulatory)\n6. Patient has had at least one HF hospitalization within 12 months and\u002For a NT-proBNP ≥1000 pg\u002Fml\n7. Interventional cardiologist believes secondary MR can be successfully treated by an interventional approach\n8. The subject has been informed of the nature of the study and agrees to the study's provisions, including the possibility of randomization to the Control group, and has provided written informed consent as approved by the respective clinical site's Ethics Committee\n\nExclusion Criteria:\n\n1. Terminal heart failure or hemodynamic instability\n2. Primary TR or MR, any other severe valvular heart disease\n3. Untreated clinically significant CAD (coronary artery disease) requiring revascularization\n4. LVEF \\\u003C35% and left bundle branch block with a QRS duration \\>150 ms\n5. Renal failure requiring dialysis\n6. Mitral valve orifice area \\\u003C4.0 cm² by site assessed TTE\n7. Life expectancy \\\u003C12 months due to non-cardiac conditions\n8. KCCQ score \\> 80 points\n9. Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated)\n10. Active infections requiring current antibiotic therapy.\n11. Known hypersensitivity or contraindication to procedural device which cannot be adequately managed medically.\n12. Patient is pregnant, nursing, or planning to be pregnant\n13. Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the investigator.\n14. Currently participating in another investigational therapeutic or interventional clinical trial, or in any trial of an unapproved drug, device or procedure. Note: Subjects participating in observational studies or registries may be considered as eligible.\n15. Ineligibility to consent","ALL","18 Years",{"count":19,"type":20},520,"ESTIMATED","INTERVENTIONAL",[23],"NA","The purpose of the ACHILLES-HF trial (ACHIeving optimaL medicaL therapy through pErcutaneous treatment of Secondary mitral regurgitation to improve outcome in Patients with Heart Failure with reduced ejection fraction) is to test whether early transcatheter edge-to-edge repair (TEER) in patients with heart failure and reduced ejection fraction (HFrEF) and relevant secondary mitral regurgitation, that are at risk of not receiving full guideline recommended therapy (GDMT), results in faster and more complete GDMT up-titration and whether this translates into improved quality of life and clinical outcomes.",[26,27],"Mitral Regurgitation Functional","Heart Failure With Reduced Ejection Fraction (HFrEF)",[29,30,31,32],"Mitral regurgitation","HFrEF","M-TEER","Guideline directed medical therapy","NOT_YET_RECRUITING","2026-08-05",{"date":36,"type":37},"2026-08-11","ACTUAL",{"date":39,"type":20},"2026-08-10",{"date":41,"type":20},"2030-09-30",{"name":43,"class":44},"University Medical Center Mainz","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":55,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100506698","evaluation-of-pcd-ct-based-image-parameters-in-the-assessment-and-quantification-of-coronary-artery-disease-100506698","NCT05877768","Evaluation of PCD-CT Based Image Parameters in the Assessment and Quantification of Coronary Artery Disease","PCD-CT Registry: Evaluation of Photon Counting Detector-CT Based Image Parameters in the Assessment and Quantification of Coronary Artery Disease (EPIPHANY)","EPIPHANY","Inclusion Criteria:\n\n* Clinical indication for a coronary computed tomography angiography (CCTA) for the suspicion of coronary artery disease or the progression thereof\n* Written informed consent\n\nExclusion Criteria:\n\n* Contraindications preventing the execution of the CCTA (e.g., pregnancy)",{"count":54,"type":20},3000,"5 Years","OBSERVATIONAL","The goal of this observational study is to learn about a new type of computed tomography (Photon-Counting Detector CT) in patients with coronary artery disease.\n\nThe main questions it aims to answer are:\n\n* How good is the image quality for the new CT\n* How accurate are measurements in the images of the new CT\n* Is there a relationship between measurements in the images and the management of the disease (e.g. new medication or additional investigations)\n* Is there a relationship between measurements in the images and the results of follow-up investigations\n* Is there a relationship between measurements in the images and the patient outcome\n\nParticipants will undergo normal clinical assessment of coronary artery disease and all data from the CT scan and additional investigations will be collected. There will be no additional investigations for the purpose of the study. After 1, 2 and 5 years, participants will be asked to answer a health questionaire.",[59],"Coronary Artery Disease","2023-05-23",{"date":62,"type":37},"2023-05-26",{"date":64,"type":20},"2023-06-30",{"date":66,"type":20},"2033-06-30",{"name":43,"class":44},1,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":68},"100386033","ramie-versus-mie-for-resectable-esophageal-cancer-a-randomized-controlled-trial-robot-2-trial-100386033","NCT04306458","RAMIE Versus MIE for Resectable Esophageal Cancer, a Randomized Controlled Trial (ROBOT-2 Trial).","Robot-assisted Minimally Invasive Thoraco-laparoscopic Esophagectomy Versus Minimally Invasive Esophagectomy for Resectable Esophageal Cancer, a Randomized Controlled Trial (ROBOT-2 Trial).","ROBOT-2","Inclusion Criteria:\n\n* Histologically proven adenocarcinoma of the intrathoracic esophagus and gastroesophageal junction (including Siewert I and II)\n* Surgically resectable (T1-4a, N0-3, M0)\n* Age ≥ 18 and ≤ 90 years\n* European Clinical Oncology Group (ECOG) performance status 0,1 or 2\n* Written informed consent\n\nExclusion Criteria:\n\n* Esophageal squamous cell carcinoma\n* Carcinoma of the cervical esophagus\n* Carcinoma of the gastro-esophageal junction (GEJ) with the main part of the tumor in the gastric cardia (Siewert type III)\n* Prior thoracic surgery at the right hemithorax or thoracic trauma","90 Years",{"count":79,"type":20},218,[23],"BACKGROUND: For patients with esophageal cancer, radical esophagectomy with 2-field lymphadenectomy is the cornerstone of the multimodality treatment with curative intent. Both, conventional minimally invasive esophagectomy (MIE) and robot assisted minimally invasive esophagectomy (RAMIE) were shown to be superior compared to open transthoracic esophagectomy considering postoperative complications. However, no randomized comparison was made until now to compare MIE to RAMIE\n\nOBJECTIVES: The objective is to evaluate the extent of lymph node dissection, efficacy, risks, quality of life and cost-effectiveness of RAMIE as an alternative to MIE as treatment for esophageal adenocarcinoma or adenocarcinoma of the gastroesophageal junction..\n\nMETHODS: This is an investigator-initiated and investigator-driven multicenter randomized controlled parallel-group, superiority trial. All adult patients (age ≥18 and ≤ 90 years) with histologically proven, surgically resectable (cT1-4a, N0-3, M0) adenocarcinoma of the intrathoracic esophagus or adenocarcinoma of the gastroesophageal junction with European Clinical Oncology Group performance status 0, 1 or 2 will be assessed for eligibility and included after obtaining informed consent. Patients (n=218) are randomized at the outpatient department to either RAMIE (n=109) or MIE (n=109). The primary outcome of this study is the total number of resected lymph nodes according to the TIGER classification for esophageal cancer lymphadenectomy.\n\nCONCLUSION: This is the first randomized controlled trial designed to compare RAMIE to MIE as surgical treatment for resectable adenocarcinoma of the intrathoracic esophagus or adenocarcinoma of the gastroesophageal junction in the Western World. If our hypothesis is proven correct, RAMIE will result in a better lymph node dissection compared to conventional MIE. The study started in September 2019. Follow up will be 5 years. Short term results will be analyzed and published after discharge of the last randomized patient.",[83],"Esophageal Adenocarcinoma",[85,86,87,88,89,90],"minimally invasive esophagectomy","robot assisted minimally invasive esophagectomy","MIE","RAMIE","lymph node dissection","lymphadenectomy","RECRUITING","2022-05-16",{"date":94,"type":37},"2022-05-17",{"date":96,"type":37},"2021-01-18",{"date":98,"type":20},"2028-01-19",{"name":43,"class":44},""]