Clinical trial NCT02981004: PAR I - Patient-to-Annulus Relation I
Official title: PAR I - Prothesis-to-Annulus Relation (PAR) as Predictor of Hemodynamic Outcome in Aortic Valve Replacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Disease
Keywords: Aortic valve disease, patient prosthesis mismatch
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2016-12-02
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with aortic valve disease selected for tissue valve implantation (routine care)

Brief summary: 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)

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 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

Primary outcomes:
measure: recording of hemodynamic outcome of a aortic valve in mutual dependence of anatomical facts on the basis of echocardiographic parameter
timeFrame: postprocedure before discharge (less than 30 days after implant)
Secondary outcomes:
measure: Mortality 30 days after implant
timeFrame: 30 days
measure: Morbidity 30 days after implant
timeFrame: 30 days
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Herzzentrum Dresden
city: Hamburg
country: Germany
facility: Asklepios St. Georg
city: Jena
country: Germany
facility: Department of Cardiothoracic Surgery
city: Munich
country: Germany
facility: Hospital Bogenhausen
city: Rotenburg
country: Germany
facility: Herz- und Kreislaufzentrum Rotenburg / Fulda
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brüder
city: Ulm
country: Germany
facility: University Hospital of Ulm
Study officials:
affiliation: Head of Cardiac surgery department
name: Torsten Doenst, M.D.Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: