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

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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. 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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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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 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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