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PAR I - Patient-to-Annulus Relation I (PARI)

This study is currently recruiting participants.
Verified November 2016 by St. Jude Medical
Sponsor:
ClinicalTrials.gov Identifier:
NCT02981004
First Posted: December 2, 2016
Last Update Posted: December 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Jude Medical
  Purpose
The Prosthesis-to-Annulus Relation I (PAR I) trial is a German multicenter study assessing the relation between the prosthetic GOA and the area of LVOT as potentially new parameter for the prediction of hemodynamic outcome. The results may possibly guide future valve size selection an may allow prediction of functionally relevant PPM (Patient-Prosthesis-Mismatch)

Condition
Aortic Valve Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: PAR I - Prothesis-to-Annulus Relation (PAR) as Predictor of Hemodynamic Outcome in Aortic Valve Replacement

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • recording of hemodynamic outcome of a aortic valve in mutual dependence of anatomical facts on the basis of echocardiographic parameter [ Time Frame: postprocedure before discharge (less than 30 days after implant) ]
    Echocardiographic evaluation of the anatomical facts e.g. Left ventricular outflow area


Secondary Outcome Measures:
  • Mortality 30 days after implant [ Time Frame: 30 days ]
    Mortality

  • Morbidity 30 days after implant [ Time Frame: 30 days ]
    Morbidity


Estimated Enrollment: 300
Study Start Date: October 2012
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Detailed Description:
Great debates revolve around the hemodynamic performance of prosthetic tissue valves. It is influenced by the design and the specific sizing strategy. Design determines the actual geometric orifice area (GOA), sizing strategy the actual size of the selected valve. Currently, hemodynamic performance is generally assessed by determining the effective orifice area (EOA, derived from the continuity equation by relating flow velocities and LVOT area). The question whether a prosthesis patient mismatch (PPM) is present is then addressed by relating EOA to body surface area (EOAi). However, this relation may not be reasonable because EOAi relates flow velocity twice to patient-specific anatomic parameters (LVOT area and body surface area) . Considering this potential methodological flaw, debate and confusion regarding PPM is easily understood, despite the fact that, intuitively leaving a gradient behind after aortic valve replacement cannot be irrelevant. Thus a reliable and comparable method to determine the presence of PPM is needed. In PAR I Trial the relation between true prothetic GOA and LVOT area will be assesses as a potentially new parameter for prediction of hemodynamic outcome, to possibly guide future valve size selection (inclusive valve-in-valve) and to allow the detection of functionally relevant PPM. In the trial it will be assessed how anatomic dimensions of patients and implanted valves relate to each other and whether they allow the prediction of hemodynamic outcome.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with aortic valve disease selected for tissue valve implantation (routine care)
Criteria

Inclusion Criteria:1.Patient has an indication for primary, isolated aortic valve implantation 2. Patient is above 18 Years old 3. Patient has signed patient informed consent 4. foreseen implantation of an Epic, Epic supra or Trifecta valve 5. Patient has sinus rhythm

Exclusion Criteria:

  1. Patient is younger than 18 years
  2. Patient has active endocarditis
  3. Patient is not able or does not want to participate on follow-up
  4. Patient is pregnant or nursing
  5. Surgical widening of outflow tract is planned
  6. Left ventricular ejection fraction is smaller than 50%
  7. Patient has a mitral valve or tricuspid valve insufficiency or stenosis bigger or equal Grade II
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02981004


Contacts
Contact: Torsten Doenst, M.D. Ph.D. 004936419322901 doenst@med.uni-jena.de

Locations
Germany
Herzzentrum Dresden Recruiting
Dresden, Germany
Contact: Klaus Matschke, M.D.         
Asklepios St. Georg Recruiting
Hamburg, Germany
Contact: Martin Oberhoffer         
Department of Cardiothoracic Surgery Recruiting
Jena, Germany, 07747
Contact: Torsten Doenst, M.D. Ph.D.    004936419322901    doenst@med.uni-jena.de   
Sub-Investigator: Mahmoud Diab, M.D.         
Hospital Bogenhausen Recruiting
Munich, Germany, 81925
Contact: Walter Eichinger, M.D.    0049 8992702631      
Herz- und Kreislaufzentrum Rotenburg / Fulda Recruiting
Rotenburg, Germany
Contact: Ardawan Rastan, M.D.         
Krankenhaus der Barmherzigen Brüder Recruiting
Trier, Germany
Contact: Alexandros Paraforos, M.D.         
University Hospital of Ulm Recruiting
Ulm, Germany
Contact: Hagen Gorki, M.D.         
Contact: Robert Bauernschmitt, M.D.         
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Torsten Doenst, M.D.Ph.D. Head of Cardiac surgery department
  More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT02981004     History of Changes
Other Study ID Numbers: CS-09-015-GE-TV
First Submitted: October 21, 2016
First Posted: December 2, 2016
Last Update Posted: December 2, 2016
Last Verified: November 2016

Keywords provided by St. Jude Medical:
Aortic valve disease, patient prosthesis mismatch

Additional relevant MeSH terms:
Heart Defects, Congenital
Heart Valve Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities