SMART Watch Facilitated Early Discharge in Patients Undergoing Transcatheter Aortic Valve Replacement

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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. POLESTAR Trial – An International Multi-center Early Discharge TAVI Program REPRISE EDGE 29 mm EU Study The CONFIDENCE Registry Interest of Cardiac Computed Tomography to Optimize and Improve the Procedure of TAVI Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System – The Engager European Pivotal Trial Post-Market Follow-up of the CENTERA Transcatheter Heart Valve System SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement The PROTEMBO SF Trial Adjuvant Radiation in Aortic Valvuloplasty – ARAVA Value of Oral Phytate (InsP6) in the Prevention of Progression of the Cardiovascular Calcifications Supra-Annular vs. Annular ValvEs for Small Annuli Heart Leaflet Technologies Valve Study A Study to Evaluate the Neuro-embolic Consequences of TAVR Femoral vs Radial Approach and MRI Evaluation of Strokes Mortality Post-TAVI and Correlation With Haemodynamic Parameters. Pilot Study of Cognitive and Functional Outcomes Following TAVI Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation Costs, Cognitive Abilities and Quality of Life After Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement SOURCE XT REGISTRY Imaging Histone Deacetylase in the Heart A pragmatiC sTrategy to Promote actIVity and Enhance Quality of Life AFTER Transcatheter Aortic Valve Replacement The PARTNER II Trial: S3iCAP Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry X-ray Fluoroscopy Fused With Computed Tomography (XFC) Technical Development First in Man Study of the JenaValve TAVI Plus System Transfemoral Evaluation of Fractional Flow Reserve Calculated by Computed Tomography Coronary Angiography in Patients Undergoing TAVR Ascending Aortic Dilation in BiAV After TAVR Safety and Performance Study of the Optimum Transcatheter Aortic Valve Transcatheter Aortic Valve Replacement With Extracorporeal Life System 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 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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 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Brief Title

SMART Watch Facilitated Early Discharge in Patients Undergoing Transcatheter Aortic Valve Replacement

Official Title

SMART TAVR: SMART Watch Facilitated Early Discharge in Patients Undergoing Transcatheter Aortic Valve Replacement

Brief Summary

      The purpose of this study is to observe conduction disturbance, daily activity level, heart
      rates, oxygen saturation in patients who underwent Transcatheter Aortic Valve Replacement
      (TAVR) and to evaluate the utility of the HUAWEI Watch (HUAWEI Technologies Co., Ltd.,
      Shenzhen, China) for the potential early warning sign of changes in multiple biometric
      parameters including heart rate, rhythm, oxygen saturation, activity, and sleep in patients
      following TAVR. This will be evaluated in the context of a recently implemented early
      discharge protocol.

Detailed Description

      This is a prospective observational cohort study including patients undergoing TAVR procedure
      in Second Affiliated Hospital of Zhejiang University, School of Medicine. HUAWEI Watch will
      be assigned to patients within 24 hours before TAVR. HUAWEI Watch GT series can continuously
      monitor and record multiple biometric parameters heart rate, step counts, sleep cycles and
      can detect and record the pulse oxygen saturation, as well as analyze QRS complexes and P
      waves after triggering. The patients will be followed in outpatient clinic visits at 1, 6,
      12, 24, and 36 months after TAVR and will commence monitoring with the HUAWEI Watch protocol
      at least 1 day before the scheduled TAVR procedure to allow familiarity with the device.
      Patients will be required to activate SMART watch readings (including pulse oxygen saturation
      and ECG) at least once prior to TAVR and twice per day in the week following TAVR discharge
      (morning and late afternoon/early evening), at least two days a week for the subsequent month
      after TAVR discharge and at least once weekly for the remainder of the study. Patients will
      also be required to activate SMART watch readings at times of any cardiovascular symptoms
      including dyspnea, chest pain, palpitations, dizziness or presyncope. The health data
      recorded by HUAWEI Watch will be transmitted to HUAWEI phone application. The Heart Health
      App (developed by Second Affiliated Hospital, School of Medicine, Zhejiang University) will
      receive, process and store the data, and transfer it to remote database after approval by
      patients. A designated heart team member would access the data via a cloud database, contact
      the patient further investigation or management was deemed necessary.

Study Type

Observational

Primary Outcome

Composite of Death and Rehospitalization

Secondary Outcome

 Composite of Death and Rehospitalization

Condition

Aortic Stenosis

Intervention

HUAWEI watch

Study Arms / Comparison Groups

 SMART watch
Description:  Medical records from patients aged 18 years or older undergoing Transcatheter Aortic Valve Replacement

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

Device

Estimated Enrollment

100

Start Date

July 1, 2020

Completion Date

July 1, 2031

Primary Completion Date

August 31, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  At least 18 years old;

          -  Be willing and able to provide informed consent to participate in the study;

          -  Not share HUAWEI Watch, HUAWEI phone with anyone else;

          -  Patient has severe aortic stenosis with echocardiographically derived criteria: mean
             gradient > 40mmHg or maximum velocity greater than 4.0 m/s or an initial aortic valve
             area of < 0.8cm2;

          -  Patient who undergoing transfemoral transcatheter aortic valve replacement.

        Exclusion Criteria:

          -  Severe complications of TAVR, such as death, and conversion to SAVR;

          -  Life expectancy is less than 12 months due to non-heart disease (such as cancer,
             chronic liver disease, chronic kidney disease, or chronic end-stage lung disease,
             etc.);

          -  Severe dementia (cannot sign research informed consent, cannot take care of themselves
             or complete the study visit);

          -  The investigator believes that the patient is not suitable to participate in the study
             or complete the follow-up prescribed by the protocol from other medical, social and
             psychological aspects;

          -  The patient is currently participating in another randomized study.

Gender

All

Ages

18 Years - N/A

Contacts

Jian-an Wang, MD, PhD, +86-15267029492, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT04454177

Organization ID

2020-330

Responsible Party

Sponsor

Study Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Sponsor

Jian-an Wang, MD, PhD, Principal Investigator, Second Affiliated Hospital, School of Medicine, Zhejiang University

Verification Date

June 2020