Pilot Trial: Comparison of Flow Patterns

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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. 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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 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Brief Title

Pilot Trial: Comparison of Flow Patterns

Official Title

Pilot Trial: Comparison of Flow Patterns. Is There a Difference Between sewed-in and "Sutureless" Bioprosthetic Aortic Heart Valves?

Brief Summary

      The purpose of this study is to determine why sutureless aortic bioprostheses apparently
      offer better haemodynamic properties compared to sewed-in aortic bioprostheses in patients
      who underwent aortic valve replacement.

      Our approach to address this question is the combination of clinical data with the
      application of specifically validated experimental and computer based analyses to compare the
      performance of these valves under patient-specific conditions.

Study Type

Interventional

Primary Outcome

Comparison of maximum and minimum velocity under patient specific conditions

Secondary Outcome

 Patient-specific, computer simulated pressure gradients compared to echocardiographically obtained pressure gradients.

Condition

Aortic Valve Stenosis

Intervention

Cardiac CT-scan

Study Arms / Comparison Groups

 "Sutureless" valve
Description:  Patients who underwent aortic valve replacement with a "sutureless" aortic valve.
An echocardiogram and a cardiac CT-scan will be conducted.

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

Radiation

Estimated Enrollment

20

Start Date

October 2014

Completion Date

December 2021

Primary Completion Date

December 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Patient underwent open aortic valve replacement with either an Edwards Magna Ease or
             an Edwards Intuity valve

          -  Implanted valve size 23mm

          -  Surgical access via full sternotomy or hemisternotomy

          -  Intuity Valve System implanted by one of the clinical investigators of the TRITON
             trial (http://clinicaltrials.gov/show/NCT01445171) at the Medical University of Vienna

          -  Post-operative ejection fraction ≥50%

          -  Sinus-Rhythm

          -  Ability to understand and comply with study procedures

          -  Signed informed consent

        Exclusion Criteria:

          -  Under 18 years of age

          -  Emergency surgery

          -  Pregnancy

          -  Previous aortic root replacement

          -  Previous aortic valve replacement

          -  Previous or concomitant root enlargement

          -  Previous or concomitant repair of the ascending aorta

          -  Paravalvular leakage

          -  Ectasia of the ascending aorta

          -  Previous or concomitant myomectomy

          -  Concomitant replacement or repair of valves other than aortic

          -  Usage of more than 3 sutures for implantation of the Intuity Valve System

          -  Heavily calcified aortic root

          -  Glomerular filtration rate (GFR) < 30 ml/min

          -  Inability to understand or comply with study procedures

          -  Known allergic reaction to iodinated, non-ionic contrast agents

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Alfred Kocher, MD, 0043-1-40400-69660, [email protected]

Location Countries

Austria

Location Countries

Austria

Administrative Informations

NCT ID

NCT02288871

Organization ID

1790/2013-1

Responsible Party

Principal Investigator

Study Sponsor

Medical University of Vienna

Collaborators

 University College, London

Study Sponsor

Alfred Kocher, MD, Principal Investigator, Division of Cardiac Surgery, Department of Surgery, Medical University of Vienna

Verification Date

March 2018