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Stenoses, Aortic clinical trials

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NCT ID: NCT05983458 Recruiting - Stenoses, Aortic Clinical Trials

SAfe and Fast Discharge With Acurate Valve in Low Risk tavI Patients

SAFARI
Start date: September 26, 2022
Phase: N/A
Study type: Interventional

Recent evidence from scientific literature supported the extension of TAVI procedures to lower risk populations. Despite its widespread usage, the expansion of TAVI into lower risk patient populations is still limited by complications and costs, with a large disparity between clinical trials and real-world scenarios suggesting still long hospitalizations after TAVI. This issue has got relevant implications in cost-effectiveness of the procedure, with many studies showing a more favourable cost profile associated with early discharges

NCT ID: NCT05714293 Enrolling by invitation - Clinical trials for Aortic Valve Stenosis

CT-evaluation of Coronary Ostia Height After Surgical Aortic Valve Replacement.

CORONATE
Start date: January 11, 2023
Phase: N/A
Study type: Interventional

The goal of this interventional, single-center study is to demonstrate if there is a change in the coronary ostia height after surgical aortic valve replacement and if it depends on the type of prosthesis or surgical technique used. The study involves patients undergoing elective surgical aortic valve replacement with a bioprosthesis. Participants enrolled will undergo a CT scan before and after surgery (at least 90 days after surgery) to analyze coronary ostia height.

NCT ID: NCT04714268 Recruiting - Aortic Aneurysm Clinical Trials

Comparison of Aorto-iliac Endovascular Interventions With and Without the EndoNaut Workstation

COM-ENDO
Start date: January 1, 2021
Phase:
Study type: Observational

The aim of this retrospective, multicenter study is to demonstrate that the use of EndoNaut for aortoiliac endovascular procedures has a clinical impact for the patient (reduction in irradiation and the volume of contrast product) as well as for the nursing staff (reduction irradiation) compared to procedures performed without EndoNaut.

NCT ID: NCT04347603 Completed - Stenoses, Aortic Clinical Trials

Sedation or General Anesthesia During TAVR

ANESTAVI
Start date: December 8, 2020
Phase: N/A
Study type: Interventional

Transcatheter aortic valve replacement TAVR is become the reference method for patients with severe aortic stenosis who are contraindicated or at risk for surgical aortic replacement. Initially performed under general anesthesia (GA), recent developpement of minimalist approach of TAVR include the use of local anesthesia (LA) with or without conscious sedation (CS) associated with full percutaneous access and no routine transoesophageal echocardiography (T0E). The aim is to simplify the procedure and to allow fast recovery of patients with early discharge and reduced cost. Evidence guiding the decision of whether to perform TAVR under GA or LA-CS is limited to non-randomized trials and registry data Current evidence is however limited by probable patient selection bias, methodological variability between studies, various methods of anesthesia and a lack of agreement regarding appropriate clinical end-points. The potential benefits of TAVR with LA include reduced procedure time, shorter intensive care unit (ICU) length of stay, reduced need for intraprocedural vasopressor support, and the potential to perform the procedure without the direct presence of an anesthetist for cost-saving reasons. As LA with CS is preferred with good results in main centers, GA may be useful to facilitate intraprocedural TOE which is necessary in case of intraprocedural complications and may facilitate the procedure for the physician particularly when the patient is anxious or disturbed. A resulted better concentration without precipitation may influence the outcomes in term of valve positioning. The patient comfort could also be better during femoral puncture or rapid pacing. The aim of the study is to compare transfemoral TAVR under general anesthesia (experimental group) versus local anaesthesia with sedation (control group) with a safety primary combined end point of adverse events at 72 h follow-up (hemodynamic parameters and VARC 3 criteria). Secondary end points include hospitalization length, satisfaction of the patients and operators and 30 days mortality. The hypothesis is a non inferoirity of the GA staregy regarding the primary end point.