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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02783248
Other study ID # 15542
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2016
Est. completion date June 30, 2022

Study information

Verified date September 2022
Source French Cardiology Society
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to validate prospectively the predictive score of late results about a diverse population recruited in France and to evaluate the contribution in predicting the outcome of the PMC scanner to study the mitral calcium score and the location of the calcifications.


Description:

This is a multicenter prospective observational study conducted in French medico-surgical sites. The Percutaneous Mitral Commissurotomy (PMC) is the standard treatment for Mitral stenosis (MS) in patients with rheumatic favorable characteristics. In Western countries the MS reaches older patients with less favorable characteristics, including the presence of mitral calcifications. Calcifications are a factor of poor outcome of the PMC. The scanner appears as a useful examination for their study but is not carried out systematically. The prediction of late results of the PMC is particularly important in patients with non-ideal characteristics which form a particularly heterogeneous population. A score of late results of the PMC on the wider western series was recently released but has not to date received external validation. In this score, prediction results was multifactorial, with a consideration of paramount clinical factors, but also a prognostic significance of mitral calcifications. The validation of predictive score of late results of the PMC, with the analysis of calcifications, would better select patients who may best benefit from PMC and those for which the surgical management is preferred. The aim of this study is to validate an external sample predictive score of the event-free survival in patients who have had a good immediate result of the PMC. This study, purely observational, does not create any special procedure outside the patient's usual care.


Recruitment information / eligibility

Status Completed
Enrollment 301
Est. completion date June 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age = 18 years - This will include all consecutive patients with rheumatic MS referred for PMC - Patients who agreed to participate in the study, with signed consent Exclusion Criteria: - Contraindication to the PMC - Contraindication to non injected scanner for centers performing a scanner - Patient Refusal to participate in the study

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Bichat Hospital Paris

Sponsors (1)

Lead Sponsor Collaborator
French Cardiology Society

Country where clinical trial is conducted

France, 

References & Publications (11)

Abascal VM, Wilkins GT, Choong CY, Thomas JD, Palacios IF, Block PC, Weyman AE. Echocardiographic evaluation of mitral valve structure and function in patients followed for at least 6 months after percutaneous balloon mitral valvuloplasty. J Am Coll Cardiol. 1988 Sep;12(3):606-15. — View Citation

Ben-Farhat M, Betbout F, Gamra H, Maatouk F, Ben-Hamda K, Abdellaoui M, Hammami S, Jarrar M, Addad F, Dridi Z. Predictors of long-term event-free survival and of freedom from restenosis after percutaneous balloon mitral commissurotomy. Am Heart J. 2001 Dec;142(6):1072-9. — View Citation

Bouleti C, Iung B, Himbert D, Messika-Zeitoun D, Brochet E, Garbarz E, Cormier B, Vahanian A. Relationship between valve calcification and long-term results of percutaneous mitral commissurotomy for rheumatic mitral stenosis. Circ Cardiovasc Interv. 2014 Jun;7(3):381-9. doi: 10.1161/CIRCINTERVENTIONS.113.000858. Epub 2014 Apr 29. — View Citation

Bouleti C, Iung B, Laouénan C, Himbert D, Brochet E, Messika-Zeitoun D, Détaint D, Garbarz E, Cormier B, Michel PL, Mentré F, Vahanian A. Late results of percutaneous mitral commissurotomy up to 20 years: development and validation of a risk score predicting late functional results from a series of 912 patients. Circulation. 2012 May 1;125(17):2119-27. doi: 10.1161/CIRCULATIONAHA.111.055905. Epub 2012 Mar 28. — View Citation

Dreyfus J, Cimadevilla C, Nguyen V, Brochet E, Lepage L, Himbert D, Iung B, Vahanian A, Messika-Zeitoun D. Feasibility of percutaneous mitral commissurotomy in patients with commissural mitral valve calcification. Eur Heart J. 2014 Jun 21;35(24):1617-23. doi: 10.1093/eurheartj/eht561. Epub 2014 Jan 6. — View Citation

Iung B, Cormier B, Ducimetière P, Porte JM, Nallet O, Michel PL, Acar J, Vahanian A. Immediate results of percutaneous mitral commissurotomy. A predictive model on a series of 1514 patients. Circulation. 1996 Nov 1;94(9):2124-30. — View Citation

Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA, O'Gara PT, Ruiz CE, Skubas NJ, Sorajja P, Sundt TM 3rd, Thomas JD; ACC/AHA Task Force Members. 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 10;129(23):e521-643. doi: 10.1161/CIR.0000000000000031. Epub 2014 Mar 3. Erratum in: Circulation. 2014 Jun 10;129(23):e651. Circulation. 2014 Sep 23;130(13):e120. Dosage error in article text. — View Citation

Palacios IF, Block PC, Wilkins GT, Weyman AE. Follow-up of patients undergoing percutaneous mitral balloon valvotomy. Analysis of factors determining restenosis. Circulation. 1989 Mar;79(3):573-9. — View Citation

Palacios IF. Percutaneous mitral balloon valvuloplasty. Does it really last as long and do as well as surgery? Adv Cardiol. 2002;39:100-13. Review. — View Citation

Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Baron-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Iung B, Lancellotti P, Pierard L, Price S, Schafers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M; Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). [Guidelines on the management of valvular heart disease (version 2012). The Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)]. G Ital Cardiol (Rome). 2013 Mar;14(3):167-214. doi: 10.1714/1234.13659. Italian. — View Citation

Wilkins GT, Weyman AE, Abascal VM, Block PC, Palacios IF. Percutaneous balloon dilatation of the mitral valve: an analysis of echocardiographic variables related to outcome and the mechanism of dilatation. Br Heart J. 1988 Oct;60(4):299-308. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Event free survival at 3 years Measurement of event-free survival after good result of the PMC, observed in our study. The composite endpoint event-free survival is defined as: cardiovascular survival without reoperation on the mitral valve and patient in NYHA I-II at last follow 3 years
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