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NCT04861805
This is a prospective, single arm, multicenter study in an cohort of up to 267 patients (up to 100 Roll-ins and 167 patients implanted per protocol) symptomatic patients with severe aortic stenosis who will be followed up for up to 5 years.
NCT05711186
Transcatheter aortic valve replacement (TAVR) is a well-established alternative to surgical aortic valve replacement (SAVR) for the treatment of patients with severe aortic stenosis regardless of surgical risk. While TAVR and SAVR share some of the benefits and risks, they importantly differ with regards to invasiveness, time to recovery, hemodynamics, as well as options for re-intervention and possibly valve durability. An early benefit of TAVR may be offset by late risks. Therefore, current guidelines of the European Society of Cardiology recommend an integration of patient values and preferences for the selection of the treatment modality. The objective of the TOGETHER trial is to investigate the efficacy of a structured shared decision making approach (SDM) to improve patient-centered outcomes for the choice between SAVR and TAVR. TOGETHER is an investigator-initiated, randomized, open-label, single-center clinical trial. A total of 140 patients referred for treatment of symptomatic severe aortic stenosis and deemed to undergo TAVR or SAVR according to heart team decision will be randomized in a 1:1 ratio to structured SDM or usual care.
NCT04663334
Change in coronary microcirculation and Fractional Flow Reserve after Transcatheter Aortic Valve Implantation in patients with concomitant coronary artery disease and severe aortic stenosis. Severe aortic stenosis is the most common indication of valvular replacement in developed countries. Stable coronary artery disease (CAD) is frequently associated with severe aortic stenosis in patients treated by Transcatheter Aortic Valvular Implantation (TAVI). Its prognostic impact is not clearly established, and available studies uncommonly used functional assessment of severity from a coronary stenosis to stratify the risk in this situation. Fractional Flow Reserve (FFR) is recommended to guide revascularization by percutaneous coronary intervention (PCI) in clinical practice. Its use is not validated in patients with severe aortic stenosis. Left ventricular hypertrophy induced by aortic obstruction leading to microvascular disorders, and can alter coronary reserve, possibly biasing FFR values. After aortic valvular replacement, a myocardial reverse remodeling is described, generating a decrease in hypertrophy, interstitial oedema, and inflammation. Its effect on coronary microcirculatory reserve is not known. Some studies have shown improvement in coronary reserve immediately after TAVI and this effect seemed to last long after treatment. The aim of the study is to assess the effects of inverse myocardial remodeling on coronary microcirculatory function and its association with FFR values before and after TAVI.
NCT04331145
The narrowing of the aortic valve, which prevents blood from reaching the entire body correctly is a common disease in our environment. To correct this problem, many patients undergo Transcatheter Aortic Valve Implantation (TAVI) according to standard clinical practice. Patients have to continue with a specific pharmacological treatment (antiplatelet agents) to avoid possible complications during the first months after the procedure. This treatment is not yet well established. Current guidelines recommend dual antiplatelet therapy with Aspirin and Clopidogrel for 3-6 months after TAVI to avoid thromboembolic complications. But the risk of bleeding events with DAPT in this population is not negligible. This study aims to determine the degree of response to Ticagrelor 60 mg every 12 hours as a single antiplatelet strategy in patients who do not achieve an adequate response with Clopidogrel 75mg every 24 hours. The study will evaluate if patients have an adequate response to Clopidogrel and if not, then patients will start treatment with Ticagrelor 60 mg every 12 hours after TAVI and until completing 3 months of treatment.
NCT02664649
ATLANTIS is a multicenter, phase IIIb, prospective, open-label, randomized trial. The objective of this study is to demonstrate superiority of a strategy of anticoagulation with apixaban (Anti-Xa Group) as compared to the current standard of care in patients who have undergone a successful TAVI procedure. The randomization is stratified according to the presence or not of a mandatory indication for anticoagulation for a reason other than the TAVI procedure (e.g. atrial fibrillation or DVT/PE).
NCT03865043
Since the first implantation by Cribier, transcatheter aortic valve implantation (TAVI) revolutionized the management of severe symptomatic aortic stenosis. Indeed, TAVI is indicated as an alternative to conventional surgery in patients at high surgical risk or contra-indicated to conventional surgery. However, TAVI remains associated with specific complications related to the technics itself dominated by vascular complications and conductive disorders. Major vascular complications remain frequent after TAVI despite improvements in operators' experience, patient's selection and lower profile devices. Indeed, according to the Valve Academic Research Consortium 2 (VARC-2) criteria , major VC are still reported with an incidence of 1.5% to 15% of the procedures in registries and may be associated with unfavorable clinical outcomes. Currently, percutaneous approach (PC) in transfemoral TAVI is performed in routine, considered as a less invasive strategy than the traditional surgical cutdown (SC) performed in the first TAVI experience. Indeed, percutaneous approach may facilitate the local anesthesia and does not require the presence of the surgeon in the catheterization laboratory . However, surgical approach is still performed in many centers, allowing a better control of the puncture site with a low rate of vascular complications . Several non-randomized studies compared the two approaches with contradictory results\]. No data are available comparing both approaches performed by the same team during the same period. The aim of this study was to compare percutaneous and surgical approaches in terms of vascular complications and bleeding in patients undergoing transfemoral TAVI.
NCT03143686
Post-market registry on ACURATE TA™ Transapical Aortic Bioprosthesis and ACURATE TA™ Delivery System implantation in patients presenting severe symptomatic aortic stenosis to provide safety surveillance of the device.