Impact of Postdilatation With the InterValve V8 Aortic Valvuloplasty Balloon Following TAVI Procedure

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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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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 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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

Impact of Postdilatation With the InterValve V8 Aortic Valvuloplasty Balloon Following TAVI Procedure

Official Title

Impact of Postdilatation With the InterValve V8 Aortic Valvuloplasty Balloon Following Medtronic CoreValve or Other Self-Expanding TAVI Procedure (PostCorE)

Brief Summary

      This study is designed to monitor the safety and performance of the V8 balloon when used as a
      postdilatation balloon in self-expanding Transcatheter Aortic Valve Implantation (TAVI)
      device procedures. The study product is CE marked for balloon aortic valvuloplasty (BAV), and
      is being investigated for an expanded intended use.

Detailed Description

      The study is a prospective, multi-center, single arm open-label clinical study involving up
      to 5 centers and a minimum of 20 subjects. Up to 50 subjects may be enrolled in this study.
      The first 3 post-dilatation procedures for each investigator will be considered roll-ins and
      not included in the main study analyses. Subjects will exit the study at hospital discharge
      or 7 days post treatment, whichever comes first. The expected duration of the clinical
      investigation is approximately 6 months.

      Subjects implanted with the CoreValve or other commercially available self-expanding TAVI and
      with the use of the V8 as a postdilatation balloon may be enrolled in this study. The subject
      will exit the study after the predischarge ECHO where the Paravalvular Leak (PVL)
      measurements are taken or resolution of a V8 related AE (if applicable).

Study Type

Observational

Primary Outcome

Efficacy Endpoint: V8 Device Performance

Secondary Outcome

 Efficacy Endpoint: Degree of Paravalvular Leak (PVL)

Condition

Aortic Valve Stenosis

Intervention

Post-dilatation

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

9

Start Date

June 2015

Completion Date

August 2016

Primary Completion Date

August 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Subjects with severe symptomatic aortic stenosis (AS) indicated and scheduled for a
             transcatheter aortic valve implant (TAVI) with the Medtronic CoreValve or another
             self-expanding TAVI device.

          -  The TAVI device size is determined preoperatively with CTA according to standard
             guidelines. Patients may undergo transfemoral, subclavian, or transaortic approach.

          -  Balloon postdilatation (BPD) is carried out after CoreValve or other self-expanding
             TAVI device implantation if, based on operator's judgment, BPD is indicated because of
             presence of paravalvular leak (PVL).

          -  Hemodynamically stable for 3 - 10 minutes after the TAVI procedure.

          -  Probable survival to hospital discharge.

          -  Subject is competent, willing to comply with evaluations, understands risks, benefits
             and alternatives and has signed the Informed Consent Form.

        Exclusion Criteria:

          -  Cardiogenic shock, as defined by a consistent systolic blood pressure <80 mmHg off
             vasopressors or <90 mmHg on vasopressors.

          -  PVL occurring secondary to excessively high or low valve positioning.

          -  Trauma or significant structural damage to underlying native tissue calls for emergent
             intervention or threatens long-term outcome prior to the BPD.

          -  Patients receiving two valves (i.e. aortic THV valve in valve).

          -  Patients with AS secondary to congenital valve disease including bicuspid aortic
             valve.

          -  PVL occurring due to TAVI device under sizing. Example of determining the undersizing
             is to calculate the Cover Index which represents the percent of over sizing of the
             nominal transcatheter heart valve (THV) area compared to the measured native valve
             annulus area. Under sizing is defined as TAVI screening CTA with a pre procedure cover
             index by area of <5%.

          -  Vulnerable subjects and any subjects incapable of giving consent, including patients
             with incurable diseases, patients in emergency situations, ethnic minority groups,
             homeless persons, nomads, refugees, minors, and subjects with cognitive impairment,
             such as persons with a mental illness or dementia.

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

, ,

Administrative Informations

NCT ID

NCT02472106

Organization ID

1302-001

Responsible Party

Sponsor

Study Sponsor

InterValve, Inc.

Study Sponsor

, ,

Verification Date

August 2016