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

PAR I - Prothesis-to-Annulus Relation (PAR) as Predictor of Hemodynamic Outcome in Aortic Valve Replacement

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)

Study Overview

• Status: Completed
• Conditions: Aortic Valve Disease

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.

• Study Type: Observational
• Enrollment (Actual): 304

Contacts and Locations

Study Locations

• Germany
  • Dresden, Germany
    • Herzzentrum Dresden
  • Hamburg, Germany
    • Asklepios St. Georg
  • Jena, Germany, 07747
    • Department of Cardiothoracic Surgery
  • Munich, Germany, 81925
    • Hospital Bogenhausen
  • Rotenburg, Germany
    • Herz- und Kreislaufzentrum Rotenburg / Fulda
  • Trier, Germany
    • Krankenhaus der Barmherzigen Brüder
  • Ulm, Germany
    • University Hospital of Ulm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with aortic valve disease selected for tissue valve implantation (routine care)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality 30 days after implant	Mortality	30 days
Morbidity 30 days after implant	Morbidity	30 days

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Torsten Doenst, M.D.Ph.D., Head of Cardiac surgery department

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2012
• Primary Completion (Actual): December 18, 2017
• Study Completion (Actual): December 18, 2017

Study Registration Dates

• First Submitted: October 21, 2016
• First Submitted That Met QC Criteria: November 30, 2016
• First Posted (Estimate): December 2, 2016

Study Record Updates

• Last Update Posted (Actual): February 7, 2019
• Last Update Submitted That Met QC Criteria: February 6, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Aortic valve disease, patient prosthesis mismatch
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Aortic Valve Disease
• Other Study ID Numbers: CS-09-015-GE-TV