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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A00464-41 | Other Identifier | IDRCB |
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The objective of this trial is to compare the safety, the efficacy and the cost-effectiveness of 2 therapeutic strategies (optimal standard of care therapy alone versus percutaneous MitraClip procedure and optimal standard of care therapy) in patients with severe secondary mitral regurgitation.
This trial is a French, multicenter and randomized trial. Patients enrolled will be clinically followed for 2 years (phone call at 1 month, clinical visit at 6 months, 12 months and 24 months).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MitraClip Device | Experimental | Subjects randomized to the MitraClip Device group will undergo the MitraClip procedure in addition to optimal standard medical therapy. |
|
| Control | Other | Patients randomized to the Control group will receive optimal therapy alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous MitraClip Device Implantation | Device | MitraClip System includes a MitraClip device, a steerable guide catheter and a MitraClip delivery system |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality and unplanned hospitalizations for heart failure | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality, cardiac mortality | 30 days, 6 months, 12 months, and 24 months. | |
| Survival with no major cardiovascular events | 30 days, 6 months, 12 months, and 24 months. | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JEAN FRANCOIS OBADIA, MD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Angers | Angers | 49933 | France | |||
| Chu de Besancon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25798568 | Background | Obadia JF, Armoiry X, Iung B, Lefevre T, Mewton N, Messika-Zeitoun D, Cormier B, Berthiller J, Maucort-Boulch D, Boutitie F, Vaz B, Trochu JN, Vahanian A. The MITRA-FR study: design and rationale of a randomised study of percutaneous mitral valve repair compared with optimal medical management alone for severe secondary mitral regurgitation. EuroIntervention. 2015 Mar;10(11):1354-60. doi: 10.4244/EIJV10I11A232. | |
| 31476260 |
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| control | Other |
|
|
| Serious Adverse Events |
Any serious adverse events cardiovascular or not occurring within each group. |
| 30 days, 6 months, 12 months and 24 months. |
| Change in Quality of Life score as measured by the European Quality of Life-5 Dimensions instrument. | 6 months and 12 months |
| Change in functional evaluation | 12 months |
| Change in echocardiographic evaluation between baseline at 6, 12 and 24 months. | 6 months, 12 months and 24 months |
| Change in biomarkers (BNP levels, creatinine) at 6 months and 12 months | 6 months and 12 months |
| Cost-effectiveness of each strategy at 12 months | Cost-effectiveness of each therapeutic strategy will be assessed by the evaluation of medical costs linked to the pathology (hospitalizations, consultations, and external medical costs (biology, radiology, medications) and compared in the 2 groups during the first 12 months of follow up. | 12 months |
| Besançon |
| France |
| Chu de Bordeaux | Bordeaux | France |
| CHRU La Cavale Blanche | Brest | France |
| Groupement Hospitalier Est | Bron | France |
| CHU Caen | Caen | 14000 | France |
| Hôpital Gabriel Montpied | Clermont-Ferrand | 63000 | France |
| APHP Hôpital Henri Mondor | Créteil | France |
| CHU de Grenoble | Grenoble | 38700 | France |
| Hôpital privé de Parly 2 | Le Chesnay | 78150 | France |
| Centre Chirurgical Marie Lannelongue | Le Plessis-Robinson | France |
| Chu de Lille | Lille | France |
| Hôpital privé le Bois | Lille | France |
| Hôpital Saint-Joseph | Marseille | 13285 | France |
| Hopital de La Timone | Marseille | France |
| Hôpital privé Clairval | Marseille | France |
| Institut Hospitalier Jacques Cartier | Massy | France |
| CH Annecy Genevois | Metz-Tessy | 74370 | France |
| Chu de Montpellier | Montpellier | France |
| Clinique Du Millenaire | Montpellier | France |
| Chu de Nancy | Nancy | France |
| Chu de Nantes | Nantes | France |
| Centre chirurgicale Ambroise Paré | Neuilly-sur-Seine | 92200 | France |
| Hôpital Pasteur | Nice | 06001 | France |
| Groupe Hospitalier La Salpétrière | Paris | 75013 | France |
| Institut Mutualiste Montsouris | Paris | 75014 | France |
| Hôpital Européen Georges Pompidou | Paris | 75015 | France |
| Aphp Hopital Bichat | Paris | France |
| CHRU La Milétrie | Poitiers | France |
| Chu de Rennes | Rennes | France |
| CHU Rouen | Rouen | France |
| Centre Cardiologique du Nord | Saint-Denis | France |
| Hôpital Nord | Saint-Etienne | 42055 | France |
| Institut Arnault Tzanck | Saint-Laurent-du-Var | France |
| Chu de Strasbourg | Strasbourg | France |
| Clinique Pasteur | Toulouse | 31076 | France |
| Chu de Toulouse | Toulouse | France |
| CHRU de Tours | Tours | France |
| Clinique Cardiologique Saint Gatien | Tours | France |
| Clinique du Tonkin | Villeurbanne | France |
| Background |
| Iung B, Armoiry X, Vahanian A, Boutitie F, Mewton N, Trochu JN, Lefevre T, Messika-Zeitoun D, Guerin P, Cormier B, Brochet E, Thibault H, Himbert D, Thivolet S, Leurent G, Bonnet G, Donal E, Piriou N, Piot C, Habib G, Rouleau F, Carrie D, Nejjari M, Ohlmann P, Saint Etienne C, Leroux L, Gilard M, Samson G, Rioufol G, Maucort-Boulch D, Obadia JF; MITRA-FR Investigators. Percutaneous repair or medical treatment for secondary mitral regurgitation: outcomes at 2 years. Eur J Heart Fail. 2019 Dec;21(12):1619-1627. doi: 10.1002/ejhf.1616. Epub 2019 Nov 18. |
| 30145927 | Result | Obadia JF, Messika-Zeitoun D, Leurent G, Iung B, Bonnet G, Piriou N, Lefevre T, Piot C, Rouleau F, Carrie D, Nejjari M, Ohlmann P, Leclercq F, Saint Etienne C, Teiger E, Leroux L, Karam N, Michel N, Gilard M, Donal E, Trochu JN, Cormier B, Armoiry X, Boutitie F, Maucort-Boulch D, Barnel C, Samson G, Guerin P, Vahanian A, Mewton N; MITRA-FR Investigators. Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation. N Engl J Med. 2018 Dec 13;379(24):2297-2306. doi: 10.1056/NEJMoa1805374. Epub 2018 Aug 27. |
| 33347327 | Derived | Iung B, Messika-Zeitoun D, Boutitie F, Trochu JN, Armoiry X, Maucort-Boulch D, Obadia JF, Vahanian A. Characteristics and Outcome of COAPT-Eligible Patients in the MITRA-FR Trial. Circulation. 2020 Dec 22;142(25):2482-2484. doi: 10.1161/CIRCULATIONAHA.120.049743. Epub 2020 Dec 21. No abstract available. |
| 32950444 | Derived | Messika-Zeitoun D, Iung B, Armoiry X, Trochu JN, Donal E, Habib G, Brochet E, Thibault H, Piriou N, Cormier B, Tribouilloy C, Guerin P, Lefevre T, Maucort-Boulch D, Vahanian A, Boutitie F, Obadia JF. Impact of Mitral Regurgitation Severity and Left Ventricular Remodeling on Outcome After MitraClip Implantation: Results From the Mitra-FR Trial. JACC Cardiovasc Imaging. 2021 Apr;14(4):742-752. doi: 10.1016/j.jcmg.2020.07.021. Epub 2020 Sep 16. |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D006349 | Heart Valve Diseases |
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D008944 | Mitral Valve Insufficiency |
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