Aortic Valve Disease Clinical Trial
— PARIOfficial title:
PAR I - Prothesis-to-Annulus Relation (PAR) as Predictor of Hemodynamic Outcome in Aortic Valve Replacement
Verified date | February 2019 |
Source | Abbott Medical Devices |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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)
Status | Completed |
Enrollment | 304 |
Est. completion date | December 18, 2017 |
Est. primary completion date | December 18, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Herzzentrum Dresden | Dresden | |
Germany | Asklepios St. Georg | Hamburg | |
Germany | Department of Cardiothoracic Surgery | Jena | |
Germany | Hospital Bogenhausen | Munich | |
Germany | Herz- und Kreislaufzentrum Rotenburg / Fulda | Rotenburg | |
Germany | Krankenhaus der Barmherzigen Brüder | Trier | |
Germany | University Hospital of Ulm | Ulm |
Lead Sponsor | Collaborator |
---|---|
Abbott Medical Devices |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Mortality 30 days after implant | Mortality | 30 days | |
Secondary | Morbidity 30 days after implant | Morbidity | 30 days |
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