PAR I - Patient-to-Annulus Relation I
PARI
PAR I - Prothesis-to-Annulus Relation (PAR) as Predictor of Hemodynamic Outcome in Aortic Valve Replacement
1 other identifier
observational
304
1 country
7
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2012
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 21, 2016
CompletedFirst Posted
Study publicly available on registry
December 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 18, 2017
CompletedFebruary 7, 2019
February 1, 2019
5.2 years
October 21, 2016
February 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Mortality 30 days after implant
30 days
Morbidity 30 days after implant
30 days
Eligibility Criteria
Patients with aortic valve disease selected for tissue valve implantation (routine care)
You may not qualify if:
- Patient is younger than 18 years
- Patient has active endocarditis
- Patient is not able or does not want to participate on follow-up
- Patient is pregnant or nursing
- Surgical widening of outflow tract is planned
- Left ventricular ejection fraction is smaller than 50%
- Patient has a mitral valve or tricuspid valve insufficiency or stenosis bigger or equal Grade II
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Herzzentrum Dresden
Dresden, Germany
Asklepios St. Georg
Hamburg, Germany
Department of Cardiothoracic Surgery
Jena, 07747, Germany
Hospital Bogenhausen
Munich, 81925, Germany
Herz- und Kreislaufzentrum Rotenburg / Fulda
Rotenburg (Wümme), Germany
Krankenhaus der Barmherzigen Brüder
Trier, Germany
University Hospital of Ulm
Ulm, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Torsten Doenst, M.D.Ph.D.
Head of Cardiac surgery department
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2016
First Posted
December 2, 2016
Study Start
October 1, 2012
Primary Completion
December 18, 2017
Study Completion
December 18, 2017
Last Updated
February 7, 2019
Record last verified: 2019-02