[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"IHF GmbH - Institut für Herzinfarktforschung\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":109},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,40,63,85],{"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":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100594455","comparing-a-suture-based-system-for-the-removal-of-arterial-and-veinous-ecmo-cannulas-to-the-standard-approach-100594455",false,"NCT07019662","Comparing a Suture-based System for the Removal of Arterial and Veinous ECMO Cannulas to the Standard Approach","CLOSE-ECMO","Inclusion Criteria:\n\n* Age ≥ 18 Years\n* Femoral placement of VA-ECMO with peripheral, percutaneous cannulation\n* Arterial puncture site above the femoral bifurcation\n* Cannula size must match or be smaller than the maximally licensed diameter for Perclose™ ProStyle™ (26 F (French) outer diameter arterial and 29 F outer diameter veinous)\n* Patients must be eligible for either the Perclose™ ProStyle™ device or one of the two guideline-compliant alternatives for ECMO cannula removal (manual compression or surgical closure) according to the investigator's judgment.\n* Initial arterial and\u002For venous puncture for ECMO cannulation was performed using ultrasound guidance with corresponding documentation available in the patient record.\n\nExclusion Criteria:\n\n* Severe calcification\n* Surgical cannulation\n* Ongoing Infection of the ECMO site\n* Any patient who does not fullfil the eligibility criteria for the use of the study device according to its current Instructions for Use (IFU), including known contraindications, limitations or warnings.\n* Participation in another interventional clinical trial.\n* Patients who are pregnant (assessed by clinical routine testing) or lactating.","ALL","18 Years",{"count":19,"type":20},102,"ESTIMATED","INTERVENTIONAL",[23],"NA","Background:\n\nPatients with severe heart and lung failure may be treated with VA-ECMO (veno-arterial extracorporeal membrane oxygenation), a life-support machine that temporarily takes over the function of the heart and lungs. To connect the patient to ECMO, large tubes (cannulas) are inserted into major blood vessels in the groin area.\n\nWhen the patient no longer needs ECMO, these cannulas must be removed - a process known as decannulation. Closing the artery after removing the cannula is a critical step and can be associated with complications such as bleeding, vessel injury, or blood clots.\n\nCurrently, there are different methods to close the artery:\n\n* Surgical closure: open surgery to directly suture the artery\n* Manual compression: pressing on the artery to stop bleeding\n* Vascular closure devices (VCDs): special tools that close the artery through the skin\n\nThere is no clear standard yet on which method is safest and most effective for ECMO patients.\n\nPurpose of the Study:\n\nThe study aims to determine whether using a vascular closure device is as safe and effective as the current standard methods for femoral artery closure after VA-ECMO.\n\nStudy Design:\n\nThis is a randomized controlled trial. Patients who are scheduled for decannulation after VA-ECMO support will be randomly assigned to one of two groups:\n\n* Intervention Group: Patients receive a vascular closure device to seal the artery (Abbott Perclose™ ProStyle™ Suture-Mediated Closure System).\n* Control Group: Patients receive standard care, which may be either:\n\n  * Manual compression, or\n  * Surgical closure, depending on the treating physician's judgment and the patient's condition.\n\nThis allows for a real-world comparison of the Closure Device method to current clinical practice.",[26],"VA-ECMO","RECRUITING","2026-04-15",{"date":30,"type":31},"2026-04-16","ACTUAL",{"date":33,"type":31},"2025-10-27",{"date":35,"type":20},"2027-09",{"name":37,"class":38},"IHF GmbH - Institut für Herzinfarktforschung","OTHER",2,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":4},"100609481","observational-study-to-collect-data-of-patient-which-recieving-a-tavi-in-tavi-procedure-100609481","NCT07215143","Observational Study to Collect Data of Patient Which Recieving a TAVI in TAVI Procedure","Transcatheter Aortic Valve Implantation With Myval THV (OCTACOR\u002FOCTAPRO) in Patients With a Failing Successfully Im-planted First Transcatheter Heart Valve","REDO-TAVI","Inclusion Criteria:\n\n* A TAVI-in-TAVI procedure with implantation of the Myval THV (Oc-taCor\u002FOctaPRO) into a previously implanted (≥3 months) failing transcatheter heart valve of any kind is either planned, has al-ready been performed, or was attempted, based on a clinical indi-cation established by the treating heart team.\n* Age: 18 years or more\n* Informed consent has been obtained.\n\nExclusion Criteria:\n\n* Participation in an interventional clinical trial\n* Limited life expectancy \\\u003C12 months\n* Foreseeable problems in performing follow-up visits",{"count":49,"type":20},300,"OBSERVATIONAL","Patients with aortic valve stenosis often undergo transcatheter aortic valve implantation (TAVI) today. This biological valve can wear out or leak over time. In such cases, a second catheter-based procedure may be necessary, in which a new valve is inserted into the old one - a so-called TAVI-in-TAVI procedure. This method is considered a gentle alternative to repeat open heart surgery.\n\nThe trial will include around 300 patients from several European centres who are scheduled to undergo or have already undergone a TAVI-in-TAVI procedure with the Myval valve. Participation includes follow-up observation for a period of up to five years. Data collection will take place exclusively within the framework of regular medical care. This includes information on pre-existing conditions, the procedure, complications and subsequent hospital stays. Imaging examinations such as echocardiography or CT scans can also be centrally evaluated if they are performed routinely.",[53],"Aortic Valve Stenosis","NOT_YET_RECRUITING","2026-03-23",{"date":57,"type":31},"2026-03-24",{"date":59,"type":20},"2026-04",{"date":61,"type":20},"2033-06",{"name":37,"class":38},{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":73,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},"100601087","trial-to-assess-non-inferiority-of-an-orbital-atherectomy-only-versus-a-calcium-tailored-debulking-approach-100601087","NCT07105930","Trial to Assess Non-inferiority of an Orbital Atherectomy Only Versus a Calcium-tailored Debulking Approach","A Randomized Controlled Multicentric Trial to Assess Non-inferiority of an Orbital Atherectomy Only Versus a Calcium-tailored Debulking Approach","OrFitA","Inclusion Criteria:\n\n* Age ≥ 18 Years\n* Chronic coronary syndrome with a clinical indication for percutaneous coronary intervention of a severely calcified lesion as defined by coronary computer tomography (CT; Agatston Score of target lesion ≥453 OR Calcium Arc \\>270°). The determination of calcification in the target lesion is based on native and contrast enhanced CT scans that are conducted as per clinical guidelines. The CT images must not be older than 6 months at the time of patient enrollment.\n* Signed informed consent\n* The patient is an appropriate candidate for bypass surgery, angioplasty, or atherectomy therapy\n\nExclusion Criteria:\n\n* Acute ST-Elevation Acute Coronary Syndrome (STE-ACS) within 48 hours\n* Cardiogenic shock\n* Chronic total occlusion of the target lesion\n* Glomerular filtration rate \\\u003C 30 ml\u002Fmin\u002F1.73 m2\n* Known presence, at the time of enrollment, of any contraindications listed in the Instructions for Use (IFU) of the investigational device:\n\n  * The OCT (optical coherence tomography) imaging catheter cannot cross\n  * The wire or imaging catheter cannot cross\n  * The target lesion is within a bypass graft or stent\n  * The patient is not an appropriate candidate for bypass surgery, angioplasty, or atherectomy therapy.\n  * The patient has angiographic evidence of thrombus\n  * The patient has only one open coronary vessel\n  * The patient has angiographic evidence of flow reducing dissection at the treatment site\n  * The patient has a known hypersensitivity to egg-, soy-, or peanut protein or to any of the active substances or excipients of the ViperSlide™ lubricant\n  * Pregnancy (assessed by clinical routine testing)\n* Participation in another interventional clinical trial",{"count":72,"type":20},310,[23],"Some patients with coronary artery disease have severely calcified vessels. In these cases, placing a stent - a small tube that helps keep the artery open - can be very difficult. Calcium build-up in the artery wall may prevent the stent from expanding properly, increasing the risk of complications or failure of the treatment.\n\nTo prepare these vessels before stenting, doctors use special techniques to modify or remove the calcium. These techniques are known as plaque modification strategies and can include devices such as atherectomy systems, scoring balloons, or intravascular lithotripsy. However, there is no clear standard as to which strategy is best.\n\nPurpose of the Study:\n\nThis study compares two different approaches to treating calcified coronary arteries before stenting:\n\n* A uniform approach using only the orbital atherectomy system (Diamondback 360®, Abbott), which sands away the calcium with a rotating crown\n* A tailored approach, where the operator chooses from various available methods (e.g., rotational atherectomy, scoring or cutting balloons, or shockwave therapy) based on the patient's specific type of calcium The goal is to determine whether the uniform orbital atherectomy approach is not worse (non-inferior) than the individualized method when it comes to how well the stent expands inside the artery.\n\nThis is a randomized, controlled clinical trial. Patients will be randomly assigned to one of the two groups.\n\nRandomization ensures fair comparison between both groups. The decision to implant a stent and to use additional techniques is at the discretion of the interventional cardiologist.",[76],"Orbital Atherectomy",{"date":78,"type":31},"2026-03-27",{"date":80,"type":31},"2025-10-30",{"date":82,"type":20},"2027-03",{"name":37,"class":38},1,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":4,"studyType":21,"phases":96,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},"100494362","bento---bronchoscopic-lung-volume-reduction-in-severe-emphysema-using-thermoablation-100494362","NCT05717192","BENTO - Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation","Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation","Inclusion Criteria:\n\n* Age: ≥ 40 years and ≤ 75 years\n* Written informed consent obtained from the patient\n* Severe emphysema with indication for BTVA:\n* bilateral heterogeneous emphysema of the upper lobes in GOLD stage 3\u002F4 and\n* evidence of severe emphysema in high-resolution computed tomography (not older than 6 months prior to inclusion) and\n* functional evidence of severe pulmonary hyperinflation and\n* FEV1 post lysis between 20% and \\\u003C 45% (calculated) and\n* Total lung capacity (TLC) ≥ 100% (calculated) and\n* Residual volume (RV) \\> 175% (calculated) and\n* arterial blood gas values of: PaCO2 ≤ 50 mmHg; PaO2 \\> 50 mmHg on room air and\n* marked dyspnoea with a score ≥ 2 on the Medical Research Council modified scale (mMRC) and\n* 6-minute walk test \\> 140 metres\n* Patient-specific, pre-interventional exhaustion of conservative treatment options\n* optimised medical therapy (according to the GOLD guidelines) and\n* Non-smoker for 6 months prior to inclusion\n* Evidence of completed pulmonary and geriatric rehabilitation in the last 4 years\n* ≥ 6 weeks outpatient or\n* ≥ 3 weeks inpatient or\n* Individual Participation in regular physical activities that go beyond the activities of daily living (e.g. a walking programme)\n* According to the investigator's assessment mentally and physically able to participate in the study procedures and visits\n* Indication within the framework of an interdisciplinary case conference with specialists in pneumology, radiology and thoracic surgery in accordance with §3 of the guideline on quality assurance measures in accordance with § 136 Paragraph 1 Sentence 1 Number 2 SGB V for inpatient care with bronchoscopic lung volume reduction procedures for severe emphysema (QS-RL BLVR).\n\nExclusion Criteria:\n\n* Any condition that would interfere with the conduct of the clinical trial follow-up or bronchoscopy or affect the outcome of the clinical trial\n* DLCO \\\u003C 20% (calculated)\n* Body mass index (BMI) \\\u003C 18 kg\u002Fm2 or \\> 32 kg\u002Fm2\n* Pulmonary hypertension\n* Peak systolic PAP \\> 45 mmHg or mean PAP \\> 25 mmHg\n* Right heart catheter measurements are considered authoritative over echocardiogram measurements\n* Clinically significant bronchiectasis\n* Pneumothorax or pleural effusions within the last 6 months\n* Heart and\u002For lung transplantation, surgical lung volume reduction (LVRS), bullectomy, lobectomy or pneumonectomy, pleurodesis or any surgery in the target lobes (upper lobes).\n* Recent respiratory infection or COPD exacerbation in the last 6 weeks\n* Unstable COPD (any of the following conditions):\n* \\>3 COPD-related hospitalisations requiring antibiotics in the last 12 months\n* COPD-related hospital stay in the last 3 months\n* daily use of systemic steroids, \\> 5 mg prednisolone\n* Single large bulla (defined as \\> 1\u002F3 of the volume of the lobe) in the upper lobe or paraseptal emphysema distribution in the lobe being treated\n* Coagulopathy or current use of anticoagulants\n* Patients with current endobronchial valves or with valves explanted less than 6 months ago in the target lobe in a segment to be treated with InterVapor®.\n* Patients with implanted, endobronchial coils (coils)\n* Patients with previous endobronchial polymer\u002Fadhesive treatment\n* Patients with immune system disorders or concomitant diseases that necessitate the use of immunosuppressants of clinical relevance\n* History of any of the following conditions:\n* Myocardial infarction or acute coronary syndrome in the previous year\n* Hospitalisation for left heart failure in the last year\n* clinically leading asthma disease or alpha-1-antitrypsin deficiency\n* Known sensitivity to medications required to perform bronchoscopy\n* Life expectancy \\\u003C 12 months\n* Newly prescribed morphine derivatives within the last 4 weeks\n* Pregnancy at the time of inclusion","40 Years","75 Years",{"count":95,"type":20},224,[23],"Prospective, 2-arm, randomised (2:1), multicentre, open-label clinical trial in patients with severe emphysema. The intervention arm will be treated with Bronchoscopic lung volume reduction in severe emphysema using thermoablation.The interventional treatment (bronchoscopic lung volume reduction) is compared with the usual conservative standard therapy (GOLD guidelines).",[99],"Emphysema or Chronic Obstructive Pulmonary Disease","2025-08-19",{"date":102,"type":31},"2025-08-24",{"date":104,"type":31},"2024-04-24",{"date":106,"type":20},"2027-12-01",{"name":37,"class":38},12,""]