Rotterdam EDOXaban Leaflet Evaluation in Patients After Transcatheter Aortic Valve Implantation

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Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement Microembolic Signals and Serum Markers of Neuronal Damage During Transcatheter Aortic Valve Implantation. CHANGE Neo™ TA Registry With ACURATE Neo™ Aortic Bioprosthesis and ACURATE Neo™ TA Transapical Delivery System FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System SMT Embolic Deflection CE Mark Trial DEFLECT I Echocardiographic Assessment of Cardiovascular Changes in Long Term Space Flight Nitinol Circular Blade Functional Assessment In TAVI: FAITAVI CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis. 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Support The TransCatheter Valve and Vessels Trial TAVR Without Predilatation Safety and Efficacy Study of MicroPort’s Transcatheter Aortic Valve and Delivery System for TAVI Enable® Aortic Sutureless Bioprosthesis Evaluation Radiation Following Percutaneous Balloon Aortic Valvuloplasty to Prevent Restenosis Myocardial Flow Reserve in Severe AS Without Obstructive Coronary Artery Disease Clinical Significance of Collagen Metabolism Changes in Left Cardiac Ventricle Medtronic CoreValve Evolut R U.S. Clinical Study (Evolut 34R Addendum) HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON CANADA Aortic Stenosis Pre-Transcatheter Aortic Valve Replacement (TAVR) Procedure CT Scan PREVAIL-20J – Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial RESPOND EDGE Post Market Study Impact of SAVR and TAVR on Patient’s Activity and Mobility BIOVALVE – I / II Clincial Investigation Comparison of Blood and Crystalloid Cardioplegia Ventriculo-arterial Coupling Modification Evaluated by PRAM During TAVI Procedure CoreValve Advance International Post Market Study HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON SWISS TAVI Registry CoreValve™ Evolut R™ FORWARD Study Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Early Feasibility Trial Follow-up After TAVR Without Systematic Intensive Care Unit Admission ACURATE NEO/TF Transcatheter Heart Valves and Non-inferiority Versus Medtronic CoreValve Systems CoreValve™ Evolut R™ 34 mm System Registry (CoreValve34) Inflammation and Thrombosis in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement (TAVR) ACURATE TA™ Valve Implantation Registry: SAVI 2 Colibri Transcatheter Aortic Heart Valve System Study HLT Meridian Valve CE Mark Trial Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Feasibility Trial CANADA Assessment of Arrhythmias in Patients Undergoing Transcatheter Aortic Valve Implantation Using a Small Insertable Cardiac Monitoring Device Reactive Oxygen Species Following Aortic Valve Replacement Biological Factors Associated With Subclinical Valvular Thrombosis Hemodynamic Comparison of Tissue Aortic Valves Volume Challenge Added to DSE in the Diagnosis of Severe LFLGAS Impact of Perioperative Treatment With Intravenous Glutamine on Myocardial Protection in Cardiac Surgery Patients With Aortic Stenosis The Effects of High Spinal Anesthesia on Heart Function, Stress Response and Pain Control in Aortic Valve Surgery A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan) Erythropoietin + Iron Therapy for Anemic Patients Undergoing Aortic Valve Replacement A Study Evaluating the Effects of Ataciguat (HMR1766) on Aortic Valve Calcification Efficacy of Angiotensin Receptor Blocker Following aortIc Valve Intervention for Aortic STenOsis: a Randomized mulTi-cEntric Double-blind Phase II Study Prehabilitation to Improve Functional and Clinical Outcomes in Patients With Aortic Stenosis Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis Phono- and Electrocardiogram Assisted Detection of Valvular Disease The Medtronic TAVR 2.0 US Clinical Study PREVAIL-J – Transfemoral & Transapical Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Japan) Regression of Myocardial Fibrosis After Aortic Valve Replacement Transcatheter Aortic Valve Replacement Versu Surgical Aortix Valve Replacement for Treating Elderly Patients With Severe Aortic Stenosis and Small Aortic Annuli: A Prospective Randomized Study The VIVA Trial ACURATE Neo™ AS Aortic Bioprosthesis for Implantation Using the ACURATE neoTM AS TF Transfemoral Delivery System in Patients With Severe Aortic Stenosis THE ALIGN-AS TRIAL: JenaValve Pericardial TAVR Aortic Stenosis Study Prognostic Impact of Myocardial Longitudinal Strain in Asymptomatic Aortic Stenosis: a Meta-Analysis Severe Aortic Valve Stenosis and Concomitant Coronary Artery Disease in Patients Undergoing TAVI Treatment of Aortic Stenosis in Brazil: Cost-Utility Analysis of TAVI vs SAVR Clinical Evaluation of MDT-2111 in Subjects With Small Aortic Annuli and Symptomatic Severe Aortic Stenosis Valvuloplasty Scoring Balloon Catheter First-in-Man Study Effect of Angiotensin II Receptor Blockers (ARB) on Left Ventricular Reverse Remodelling After Aortic Valve Replacement in Severe Valvular Aortic Stenosis Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve Registry to Evaluate the Impact of a Valve Coordinator on Aortic Stenosis / TAVI Outcome – (German Pilot) Quality of Care in AS IMPULSE Study Biomarkers in Aortic Stenosis – B.A.S.S. CoreValve® System Australia/New Zealand Clinical Study The Role of Cardiac Mechanics, Biomarkers and Frailty in Aortic Stenosis High-Sensitivity Troponin T Plasma Levels in Patients With Aortic Stenosis (Tyrolean Aortic Stenosis Study-2) Role of Active Valvular Calcification and Inflammation in Patients With Aortic Stenosis Interest of Pulse Wave Velocity Measurement as a Predictor of Severity of Aortic Stenosis A Prospective Study of Fractional Flow Reserve Assessment of Intermediate Coronary Stenoses in Severe Aortic Stenosis Prospective Balloon Aortic Valvuloplasty Identification of Parameters in rapId-proGression Subgroup Patients With Moderate Aortic Stenosis RHEIA (Randomized researcH in womEn All Comers With Aortic Stenosis) Effects of High Dose Atorvastatin in Patients With Surgical Aortic Stenosis Early Surgery for Patients With Asymptomatic Aortic Stenosis Predicting Aortic Stenosis Progression by Measuring Serum Calcification Propensity Bicuspid Aortic Valve Stenosis and the Effect of vItamin K2 on Calciummetabolism on 18F-NaF PET/MRI Endothelial Progenitors in Aortic Stenosis: Association With Aortic Stenosis Progression and Severity Outcomes of Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis Evaluation of BAV in Different Hemodynamic Entities of Severe AS Intravenous Iron Supplement for Iron Deficiency in Patients With Severe Aortic Stenosis The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic Severe Aortic Stenosis Clinical Value of Stress Echocardiography in Moderate Aortic Stenosis CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement Outcomes of Transcatheter Aortic Valve Implantation in Management of Severe Symptomatic Aortic Stenosis Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population Rehabilitation in Aortic Stenosis Patients Aortic Stenosis Evaluated Via Modern Ballistocardiography and Seismocardiography Study of Platelet Activation by Severe Aortic Stenosis and Its Correction by Transcatheter Aortic Valve Implantation Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve The Plasma Serotonin and Aortic Stenosis: a Pilot Study. 18F-NaF Uptake and Aortic Stenosis Progression Cardiovascular Rehabilitation in Patients With Severe Aortic Stenosis Submitted to Valvar Correction Aortic Stenosis and PhosphodiEsterase Type 5 iNhibition (ASPEN): A Pilot Study Clinical Outcome of Patients With Low-gradient Severe Aortic Stenosis Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis Fetal Intervention for Aortic Stenosis and Evolving Hypoplastic Left Heart Syndrome The PARTNER 3 – Trial – The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis Ventricular Remodeling In Patients With Aortic Stenosis Assessed Echocardiography Podocan and Wnt Pathway in Left Ventricular Remodeling of Aortic Stenosis Preoperative Assessment of Aortic Valve Stenosis and Coronary Artery Disease Statin Therapy in Asymptomatic Aortic Stenosis Validation of the “TASQ” in Patients Undergoing SAVR or TF-TAVI Analysis and Comparative Evaluation of Aortic Calcium by Computed Tomography and Histopathology in Patients With Aortic Stenosis Improving Echo Measurements in the Diagnosis of Aortic Stenosis accuRate Evaluation of Benefit With Optimal Medical Treatment With or With-Out Transcatheter Valve Repair of PARADOXical Low Flow Low Gradient Aortic Stenosis – REBOOT-PARADOX Aortic Stenosis: Determinants and Prognostic Value of Preoperative Left Ventricular Remodeling After Valvular Replacement Randomized Study for the Optimal Treatment of Symptomatic Patients With Low Gradient Severe Aortic Valve Stenosis and Preserved Left Ventricular Ejection Fraction Microvascular Dysfunction in Aortic Stenosis Percutaneous Aortic Valve 18F System for the Treatment of Patients With Severe Aortic Stenosis Determination of the Acute Effects of Aortic Stenosis on Coronary Artery Haemodynamics Mechanism of Decompensation Evaluation – Aortic Stenosis Speckle Tracking Imaging in Patients With Low Ejection Fraction Aortic Stenosis (SPArKLE-AS) A Comparison of Advanced Imaging Techniques in Aortic Stenosis Aortic Valve Replacement Versus Conservative Treatment in Asymptomatic Severe Aortic Stenosis Microparticles in Severe Aortic Stenosis Aortic Stenosis and PhosphodiEsterase iNhibition With Aortic Valve Replacement (ASPEN-AVR): A Pilot Study An Investigational Drug on Clinical Outcomes in Patients With Aortic Stenosis (Narrowing of the Major Blood Vessel of the Heart)(MK-0653A-043 AM4)(COMPLETED) Clinical Evaluation of MDT-2111 in Subjects With Symptomatic Severe Aortic Stenosis Acute Hemodynamic Effects of Sildenafil in Patients With Severe Aortic Stenosis Transapical Transcatheter Treatment Versus Conventional Surgery in Patients With Native Aortic Valve Stenosis Measurement of Myocardial Stiffness Using Elastometry in Patients With Aortic Stenosis Study to Improve Outcomes in Aortic Stenosis Multicenter Prospective Study of Low-Flow Low-Gradient Aortic Stenosis (TOPAS Study) Severe Aortic Stenosis in Patients Referred for Valve Surgery Frailty and Mortality in Older Old With Severe Aortic Stenosis Myocardial Efficiency of the Left Ventricle in Asymptomatic Patients With Aortic Valve Stenosis – a Prognostic Marker and a Target for Intervention? PCSK9 Inhibitors in the Progression of Aortic Stenosis Early Surgery Versus Conventional Treatment in Very Severe Aortic Stenosis Randomized Study to Evaluate the Efficacy of Fluvastatin on Inflammatory Markers in Patients With Aortic Stenosis. 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Brief Title

Rotterdam EDOXaban Leaflet Evaluation in Patients After Transcatheter Aortic Valve Implantation

Official Title

Rotterdam EDOXaban Leaflet Evaluation in Patients After Transcatheter Aortic Valve Implantation

Brief Summary

      A single-center, investigator-initiated, single arm interventional study in patients
      undergoing transfemoral transcatheter aortic valve replacement (TAVR) in the Erasmus Medical
      Center in Rotterdam (NL). Study population will be patients undergoing TAVR with no formal
      indication for oral anticoagulant (OAC) and no dual antiplatelet therapy (DAPT) requirement
      for coronary stents. Primary endpoint is the incidence of leaflet thickening on MSCT after
      three months of edoxaban treatment.

Detailed Description

      Rationale: Thromboembolic- and bleeding events can occur after TAVI and can have great
      consequences. There is currently no evidence-based guideline on prevention of thromboembolic
      events after TAVI and the current standard of care with DAPT 3-6 months is based on expert
      opinion. Recently multislice computed tomography (MSCT) studies identified bioprosthesis
      leaflet thickening and impaired leaflet motion after TAVI. The goal of this study is to
      investigate whether in TAVI patients, treatment with edoxaban leads to a reduction in leaflet
      thickening incidence after 3 months and whether it is safe and clinically efficient.

      Objective: To investigate whether treatment with edoxaban leads to a decrease in incidence of
      leaflet thickening and is clinical efficient and safe.

      Study design: A single-center, investigator-initiated, open-label, observational study.

      Study population: Patients undergoing transfemoral transcatheter aortic valve replacement in
      the Erasmus University Medical Center with no formal novel oral
      anticoagulants/vitamin-K-antagonist (NOAC/VKA) indication.

      Intervention (if applicable): Patients will be treated with edoxaban for a period of 3 months
      following TAVI. Afterwards they will switch to acetylsalicylic acid.

      Main study parameters/endpoints: The incidence of leaflet thickening on MSCT 3 months after
      TAVI and edoxaban treatment.

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: Thus far edoxaban has proven to be safe and non-inferior to treatment with
      warfarin in several indications. The role of anticoagulant agents in TAVI still has to be
      unravelled. Subjects participating in this trial are possibly at higher risk for bleeding
      complications than patients being treated with dual antiplatelet therapy after TAVI.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Incidence of aortic valve leaflet thickening after TAVI as assessed by cardiac 4D computed tomography scan (4DCT)

Condition

Aortic Valve Stenosis

Intervention

Edoxaban

Study Arms / Comparison Groups

 Edoxaban
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

100

Start Date

August 1, 2019

Completion Date

February 1, 2021

Primary Completion Date

January 1, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Completed successful elective TAVI for severe native aortic valve stenosis with any
             commercially-available transcatheter heart valve (THV).

               -  Correct positioning of a single prosthetic heart valve

               -  Device success, defined by:

                    -  Mean aortic valve gradient < 20 mmHg

                    -  Peak transvalvular velocity < 3.0 m/s

                    -  Aortic valve regurgitation of 2 or less

          -  No periprocedural complications.

               -  No overt stroke

               -  No uncontrolled bleeding

               -  No major vascular complication defined by the Valve academic research committee 2
                  (VARC-2) consensus

          -  No formal indication for oral anticoagulation

               -  Prevention of thromboembolic complications in patients with atrial fibrillation

               -  Prevention for recurrent venous thromboembolism

               -  Prevention for recurrent pulmonary embolism

        Exclusion Criteria:

          -  History of life-threatening or major bleeding event ≥ Bleeding academic research
             committee (BARC) 3b definitions within the last year.

          -  Conditions with a high risk of bleeding

               -  Active peptic ulcer or upper gastrointestinal bleeding (< 3 months)

               -  Malignancy with high risk of bleeding

               -  Recent unresolved brain of spinal injury

               -  Spinal or ophthalmic surgery within last 3 months prior to enrolment

               -  Intracranial haemorrhage

               -  Esophagal varices

               -  Arteriovenous malformations with high risk of bleeding

               -  Vascular aneurysms

               -  Major intraspinal or intracerebral vascular abnormalities

          -  Hypersensitivity or contraindications to edoxaban

          -  No percutaneous coronary intervention within 6 months prior to randomization
             (requiring DAPT after TAVR)

          -  Dialysis-dependency or glomerular filtration rate < 30 mL/min at time of enrollment

          -  Active bleeding or bleeding diathesis including thrombocytopenia (platelet count <
             50.000 cells/UL), thromboasthenia, haemophilia or von Willebrand disease

          -  Patients unable to adhere to or complete the investigational protocol for any reason
             including but not limited to geographical residence, psychiatric condition or
             life-threatening disease

          -  Pregnant or breast-feeding subjects

          -  Current participation in clinical trials that potentially interfere with the current
             study

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, +31(0)107035260, [email protected]

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations

NCT ID

NCT04171726

Organization ID

REDOX TAVI

Responsible Party

Principal Investigator

Study Sponsor

Erasmus Medical Center

Collaborators

 Daiichi Sankyo, Inc.

Study Sponsor

, ,

Verification Date

November 2019