Aortic Valve DiseasePARINCT02981004
PAR I - Patient-to-Annulus Relation I
An observational study of Aortic Valve Disease, run by Abbott Medical Devices at 7 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Disease
- How many people
- 304 participants
- Where
- 7 sitesGermany
- Study dates
- Oct 2012to 18 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with aortic valve disease selected for tissue valve implantation (routine care)
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Herzzentrum Dresden
Dresden
Asklepios St. Georg
Hamburg
Department of Cardiothoracic Surgery
Jena, 07747
Hospital Bogenhausen
Munich, 81925
Herz- und Kreislaufzentrum Rotenburg / Fulda
Rotenburg (Wümme)
Krankenhaus der Barmherzigen Brüder
Trier
University Hospital of Ulm
Ulm
About this study
Official title: 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)
Read the 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.
- Conditions
- Aortic Valve Disease
- Keywords
- Aortic valve disease, patient prosthesis mismatch
- Medical subject headings
- Aortic Valve Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: postprocedure before discharge (less than 30 days after implant)
Secondary outcomes (2)
Mortality 30 days after implant
Mortality
Measured: 30 days
Morbidity 30 days after implant
Morbidity
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startOct 2012
- Primary completion18 Dec 2017
- Study completion18 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Torsten Doenst, M.D.Ph.D., Principal investigator, Head of Cardiac surgery department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02981004
- Sponsor's protocol ID
- CS-09-015-GE-TV
- Acronym
- PARI
- Status last verified
- Feb 2019
- First submitted
- 21 Oct 2016
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PAR I - Prothesis-to-Annulus Relation (PAR) as Predictor of Hemodynamic Outcome in Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT02981004
- Acronym / sponsor ID
- PARI / CS-09-015-GE-TV
- Conditions
- Aortic Valve Disease
- Keywords
- Aortic valve disease, patient prosthesis mismatch
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Oct 2012 (actual)
- Primary completion
- 18 Dec 2017 (actual)
- Study completion
- 18 Dec 2017 (actual)
- First posted
- 2 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with aortic valve disease selected for tissue valve implantation (routine care)
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Mortality 30 days after implant
Time frame: 30 days
Morbidity 30 days after implant
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torsten Doenst, M.D.Ph.D. principal investigator
Head of Cardiac surgery department
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Disease, run by Abbott Medical Devices at 7 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2019.