Heart Valve DiseasesNCT00629902
Heart Valve Prosthesis-Patient Mismatch
An observational study of Heart Valve Diseases, run by Florence Nightingale Hospital, Istanbul at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to determine the frequency of prosthesis-patient mismatch after mitral valve replacement and its effect on clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Valve Diseases
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2008to May 2008
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Tertiary care clinic
Who may be able to join
- Patients > 18 years with a clinical condition of mitral valve prosthesis
Who cannot join
- Evidence of prosthesis valve dysfunction (dehisence, endocarditis or thrombus of prosthetic mitral valve)
- Concomitant aortic valve prosthesis and tricuspid valve prosthesis
- Presence of > +2 aortic valve regurgitation and/or mild aortic stenosis
- Prosthetic mitral valve replacement operation < 6 months
- Left ventricular ejection fraction < 50%
- Chronic obstructive pulmonary disease
- Concomitant hypertrophic cardiomyopathy, atrial septal defect
- Patients with poor ehocardiographic window
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
T.C. Bilim University, Medical Faculty, Florence Nightingale Hospital, Division of Cardiology
Istanbul, Sisli, 34381
About this study
Official title: Impact of Prosthesis-Patient Mismatch on Clinical Outcomes After Mitral Valve Replacement
The purpose of this study is to determine the frequency of prosthesis-patient mismatch after mitral valve replacement and its effect on clinical outcomes.
Read the detailed description
Mitral valve replacement (MVR) is associated with higher short and long term mortality than aortic valve replacement or mitral valve repair. The suboptimal results of MVR underline the importance of identifying and preventing prosthesis- patient mismatch. The effective orifice area (EOA) of prosthetic valves used for MVR is often too small in relation to body size, thus causing a mismatch between valve EOA and transvalvular flow. As a consequence, normally functioning mitral prostheses often have relatively high gradients that are similar to those found in patients with mild to moderate mitral stenosis. Residual pressure gradients across mitral prostheses delay the regression of left atrial and pulmonary arterial hypertension. Pulmonary hypertension may cause rightsided failure and is an important risk factor for morbidity and mortality in patients with cardiovascular diseases. However data about the frequency of prosthesis-patient mismatch after mitral valve replacement and its effect on clinical outcome is inconclusive. Predetermined outcomes will be evaluated in the clinical course of this condition.
- Conditions
- Heart Valve Diseases
- Keywords
- Heart valve prosthesis
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A1 | Patients with prosthesis-patient mismatch after mitral valve replacement | |
| A2 | Patients without prosthesis mismatch after mitral valve replacement |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart Valve DiseasesStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florence Nightingale Hospital, Istanbul
- Sponsor type
- University, hospital or other
- Investigators
- Saide Aytekin, Professor, Principal investigator, T.C. Istanbul Bilim University, Medical Faculty, Florence Nightingale Hospital, Division of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00629902
- Sponsor's protocol ID
- AT-1974
- Status last verified
- May 2008
- First submitted
- 27 Feb 2008
- Last updated
- 12 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Totaro P, Argano V. Patient-prosthesis mismatch after mitral valve replacement: myth or reality? J Thorac Cardiovasc Surg. 2007 Sep;134(3):697-701. doi: 10.1016/j.jtcvs.2007.04.031.
PubMed 17723820Li M, Dumesnil JG, Mathieu P, Pibarot P. Impact of valve prosthesis-patient mismatch on pulmonary arterial pressure after mitral valve replacement. J Am Coll Cardiol. 2005 Apr 5;45(7):1034-40. doi: 10.1016/j.jacc.2004.10.073.
PubMed 15808760Magne J, Mathieu P, Dumesnil JG, Tanne D, Dagenais F, Doyle D, Pibarot P. Impact of prosthesis-patient mismatch on survival after mitral valve replacement. Circulation. 2007 Mar 20;115(11):1417-25. doi: 10.1161/CIRCULATIONAHA.106.631549. Epub 2007 Mar 5.
PubMed 17339554
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Prosthesis-Patient Mismatch on Clinical Outcomes After Mitral Valve Replacement
- ClinicalTrials.gov ID
- NCT00629902
- Acronym / sponsor ID
- AT-1974
- Conditions
- Heart Valve Diseases
- Keywords
- Heart valve prosthesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Florence Nightingale Hospital, IstanbulUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 6 Mar 2008 (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 purpose of this study is to determine the frequency of prosthesis-patient mismatch after mitral valve replacement and its effect on clinical outcomes.
Detailed description
Mitral valve replacement (MVR) is associated with higher short and long term mortality than aortic valve replacement or mitral valve repair. The suboptimal results of MVR underline the importance of identifying and preventing prosthesis- patient mismatch. The effective orifice area (EOA) of prosthetic valves used for MVR is often too small in relation to body size, thus causing a mismatch between valve EOA and transvalvular flow. As a consequence, normally functioning mitral prostheses often have relatively high gradients that are similar to those found in patients with mild to moderate mitral stenosis. Residual pressure gradients across mitral prostheses delay the regression of left atrial and pulmonary arterial hypertension. Pulmonary hypertension may cause rightsided failure and is an important risk factor for morbidity and mortality in patients with cardiovascular diseases. However data about the frequency of prosthesis-patient mismatch after mitral valve replacement and its effect on clinical outcome is inconclusive. Predetermined outcomes will be evaluated in the clinical course of this condition.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A1 | – | –Patients with prosthesis-patient mismatch after mitral valve replacement |
| A2 | – | –Patients without prosthesis mismatch after mitral valve replacement |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tertiary care clinic
Key inclusion criteria (1 listed)
- Patients > 18 years with a clinical condition of mitral valve prosthesis
Key exclusion criteria (8 listed)
- Evidence of prosthesis valve dysfunction (dehisence, endocarditis or thrombus of prosthetic mitral valve)
- Concomitant aortic valve prosthesis and tricuspid valve prosthesis
- Presence of > +2 aortic valve regurgitation and/or mild aortic stenosis
- Prosthetic mitral valve replacement operation < 6 months
- Left ventricular ejection fraction < 50%
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
Not reported in the source record.
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 12 May 2008.
- Background: PubMed 17723820Totaro P, Argano V. Patient-prosthesis mismatch after mitral valve replacement: myth or reality? J Thorac Cardiovasc Surg. 2007 Sep;134(3):697-701. doi: 10.1016/j.jtcvs.2007.04.031.
- Background: PubMed 15808760Li M, Dumesnil JG, Mathieu P, Pibarot P. Impact of valve prosthesis-patient mismatch on pulmonary arterial pressure after mitral valve replacement. J Am Coll Cardiol. 2005 Apr 5;45(7):1034-40. doi: 10.1016/j.jacc.2004.10.073.
- Background: PubMed 17339554Magne J, Mathieu P, Dumesnil JG, Tanne D, Dagenais F, Doyle D, Pibarot P. Impact of prosthesis-patient mismatch on survival after mitral valve replacement. Circulation. 2007 Mar 20;115(11):1417-25. doi: 10.1161/CIRCULATIONAHA.106.631549. Epub 2007 Mar 5.
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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.
Saide Aytekin, Professor principal investigator
T.C. Istanbul Bilim University, Medical Faculty, Florence Nightingale Hospital, Division of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Valve Diseases, run by Florence Nightingale Hospital, Istanbul at 1 site in Turkey (Türkiye).
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 1 inclusion and 8 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 12 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00629902, which also lists 3 linked publications.
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 12 May 2008.