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| Name | Class |
|---|---|
| Meditrial Europe Ltd. | INDUSTRY |
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To explore the impact of early transcatheter edge-to-edge repair of acute functional mitral regurgitation after myocardial infarction on the combined incidence of death and heart-failure associated hospitalisations at one-year follow-up, and quality of life and LV remodelling at two-year follow-up.
Prospective, multicentre, randomised, open-label, comparative effectiveness clinical trial for the treatment of clinically significant functional mitral regurgitation within 60 days after acute myocardial infarction, who are treated per standard of care and who have been determined by the site's local heart team as inappropriate or too high risk for mitral valve surgery.
Eligible subjects will be randomized in a 1:1 ratio to the MitraClip device (intervention group) or to no MitraClip device (Control group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEER + OMT | Experimental | Early transcatheter edge-to-edge mitral valve repair (TEER) plus optimal medical treatment |
|
| OMT | Other | Optimal medical treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early transcatheter edge-to-edge mitral valve repair (TEER). | Procedure | TEER will be planned and performed as soon as possible, but within 60 days after index myocardial infarction, and within 30 days of randomisation using the MitraClip device. |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause death or Cumulative Heart Failure hospitalizations | Composite of
| 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isaac Pascual MD, PhD | Contact | 985101738 | ipascua@live.com | |
| Pablo Avanzas, MD, PhD | Contact | 985101738 | avanzas@secardiologia.es |
| Name | Affiliation | Role |
|---|---|---|
| Isaac Pascual, MD, PhD | Hospital Universitario Central de Asturias | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emek Medical Center | Not yet recruiting | Afula | Afula | 1834111 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21900289 | Background | Pocock SJ, Ariti CA, Collier TJ, Wang D. The win ratio: a new approach to the analysis of composite endpoints in clinical trials based on clinical priorities. Eur Heart J. 2012 Jan;33(2):176-82. doi: 10.1093/eurheartj/ehr352. Epub 2011 Sep 6. | |
| 10399200 | Background | Finkelstein DM, Schoenfeld DA. Combining mortality and longitudinal measures in clinical trials. Stat Med. 1999 Jun 15;18(11):1341-54. doi: 10.1002/(sici)1097-0258(19990615)18:113.0.co;2-7. |
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Prospective, multicentre, randomised, open-label, comparative effectiveness clinical trial for the treatment of clinically significant functional mitral regurgitation within 60 days after acute myocardial infarction, who are treated per standard of care and who have been determined by the site's local heart team as inappropriate or too high risk for mitral valve surgery.
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| MitraClip | Device | MitraClip |
|
| Optimal medical treatment | Other | Optimal medical treatment |
|
| Shaare Zedek Medical Center | Recruiting | Jerusalem | Jerusalen | 9103102 | Israel |
|
| Rabin Medical Center | Not yet recruiting | Petah Tikva | Petah Tikva | 4941492 | Israel |
|
| Sheba Medical Center | Not yet recruiting | Ramat Gan | Ramat Gan | Israel |
|
| Civil Hospital of Brescia | Not yet recruiting | Brescia | Brescia | 25123 | Italy |
|
| Ospedale Policlinico San Martino | Not yet recruiting | Genova | Genova | 16132 | Italy |
|
| San Raffaele Hospital | Not yet recruiting | Milan | Milano | 20132 | Italy |
|
| Centro Cardiológico Monzino | Not yet recruiting | Milan | Milan | 20138 | Italy |
|
| Policlínico San Donato | Not yet recruiting | San Donato Milanese | San Donato Milanese | 20097 | Italy |
|
| Amsterdam University Medical Center | Not yet recruiting | Amsterdam | Amsterdam | 1081 HV | Netherlands |
|
| Amphia Hospital | Not yet recruiting | Breda | Breda | 4818 CK | Netherlands |
|
| Catharina Ziekenhuis Hospital | Not yet recruiting | Eindhoven | Eindhoven | 5623 EJ | Netherlands |
|
| Leiden University Medical Center | Not yet recruiting | Leiden | Leiden | 2333 ZA | Netherlands |
|
| Maastricht University Medical Center | Not yet recruiting | Maastricht | Maastricht | 6229 HX | Netherlands |
|
| St. Antonius Hospital | Not yet recruiting | Nieuwegein | Nieuwegein | 3435 CM | Netherlands |
|
| Erasmus University Medical Center | Not yet recruiting | Rotterdam | Rotterdam | 3015 GD | Netherlands |
|
| Isala Hospital | Not yet recruiting | Zwolle | Zwolle | 8025 AB | Netherlands |
|
| Hospital General Universitario Dr. Balmis | Not yet recruiting | Alicante | Alicante | 03010 | Spain |
|
| Hospital de la Santa Creu i Sant Pau | Not yet recruiting | Barcelona | Barcelona | 08025 | Spain |
|
| Hospital Universitario Vall d'Hebrón | Not yet recruiting | Barcelona | Barcelona | 08035 | Spain |
|
| Hospital Clínic Barcelona | Not yet recruiting | Barcelona | Barcelona | 08036 | Spain |
|
| Hospital Universitario de Bellvitge | Not yet recruiting | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
|
| Hospital Universitario Marqués de Valdecilla | Not yet recruiting | Santander | Cantabria | 39008 | Spain |
|
| Hospital Universitario Reina Sofía | Not yet recruiting | Córdoba | Córdoba | 14004 | Spain |
|
| Hospital Universitario Doctor Negrin | Not yet recruiting | Las Palmas de Gran Canaria | Las Palmas | 35010 | Spain |
|
| Hospital Universitario Ramón y Cajal | Not yet recruiting | Madrid | Madrid | 28034 | Spain |
|
| Hospital Clínico Universitario San Carlos | Not yet recruiting | Madrid | Madrid | 28040 | Spain |
|
| Hospital Universitario Puerta de Hierro | Not yet recruiting | Madrid | Madrid | 28222 | Spain |
|
| Hospital Universitario Virgen de la Victoria | Not yet recruiting | Málaga | Málaga | 29010 | Spain |
|
| Hospital Álvaro Cunqueiro | Not yet recruiting | Vigo | Pontevedra | 36312 | Spain |
|
| Hospital Universitario Central de Asturias (HUCA) | Recruiting | Oviedo | Principality of Asturias | 33011 | Spain |
|
| Hospital Clínico Universitario de Valladolid | Not yet recruiting | Valladolid | Valladolid | 47003 | Spain |
|
| 37209883 | Background | Shuvy M, Maisano F, Strauss BH. Transcatheter Mitral Edge-to-Edge Repair for Treatment of Acute Mitral Regurgitation. Can J Cardiol. 2023 Oct;39(10):1382-1389. doi: 10.1016/j.cjca.2023.05.009. Epub 2023 May 18. |
| 36599332 | Background | Shuvy M, von Bardeleben RS, Grasso C, Raake P, Lurz P, Zamorano JL, Asch F, Kar S, Maisano F; EXPAND Investigators. Safety and efficacy of MitraClip in acutely ill (NYHA Class IV) patients with mitral regurgitation: Results from the global EXPAND study. ESC Heart Fail. 2023 Apr;10(2):1122-1132. doi: 10.1002/ehf2.14273. Epub 2023 Jan 4. |
| 34463727 | Background | Haberman D, Estevez-Loureiro R, Benito-Gonzalez T, Denti P, Arzamendi D, Adamo M, Freixa X, Nombela-Franco L, Villablanca P, Krivoshei L, Fam N, Spargias K, Czarnecki A, Pascual I, Praz F, Sudarsky D, Kerner A, Ninios V, Gennari M, Beeri R, Perl L, Wasserstrum Y, Danenberg H, Poles L, George J, Caneiro-Queija B, Scianna S, Moaraf I, Schiavi D, Scardino C, Corpataux N, Echarte-Morales J, Chrissoheris M, Fernandez-Peregrina E, Di Pasquale M, Regueiro A, Vergara-Uzcategui C, Iniguez-Romo A, Fernandez-Vazquez F, Dvir D, Maisano F, Taramasso M, Shuvy M. Conservative, surgical, and percutaneous treatment for mitral regurgitation shortly after acute myocardial infarction. Eur Heart J. 2022 Feb 12;43(7):641-650. doi: 10.1093/eurheartj/ehab496. |
| 33069653 | Background | Jung RG, Simard T, Kovach C, Flint K, Don C, Di Santo P, Adamo M, Branca L, Valentini F, Benito-Gonzalez T, Fernandez-Vazquez F, Estevez-Loureiro R, Berardini A, Conti N, Rapezzi C, Biagini E, Parlow S, Shorr R, Levi A, Manovel A, Cardenal-Piris R, Diaz Fernandez J, Shuvy M, Haberman D, Sala A, Alkhouli MA, Marini C, Bargagna M, Schiavi D, Denti P, Markovic S, Buzzatti N, Chan V, Hynes M, Mesana T, Labinaz M, Pappalardo F, Taramasso M, Hibbert B. Transcatheter Mitral Valve Repair in Cardiogenic Shock and Mitral Regurgitation: A Patient-Level, Multicenter Analysis. JACC Cardiovasc Interv. 2021 Jan 11;14(1):1-11. doi: 10.1016/j.jcin.2020.08.037. Epub 2020 Oct 14. |