Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter (AMTRAC) Valve Registry

NCT04031274 | Unknown FDA Device

• 1 other identifier: 19-178923
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

an international multicentre registry designed to answer 3 clinical questions:

1. 1.Describing the characteristics and outcomes of current patients undergoing aortic + mitral transcatheter heart valve procedures.
2. 2.Better understanding of the predictors for MR regression following isolated TAVI and consequently estimating the fraction of patients who will be suitable for TMVR/r post TAVI
3. 3.Examining the clinical outcomes of patients with significant MR post TAVI who subsequently underwent TMVR/r compared to those left for medical management.

Conditions

Aortic Stenosis; Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

• Overall mortality

  Death from any cause

  UP to 10 years of follow up

Secondary Outcomes (4)

• Periprocedural complications

  In-hospital/30 days

• Periprocedural mortality

  In-hospital/30 days

• NYHA Class

  1,3,6,12 months and up to 10 years of follow up

• Mitral regurgitation grade

  1,3,6,12 months and up to 10 years of follow up

Study Arms (3)

TAVI no MR

Patients undergoing TAVI with MR up to moderate following the procedure

Device: TAVI

TAVI + MR no further intervention

Patients undergoing TAVI with MR more than moderate following the procedure, no further mitral valve intervention

Device: TAVI

TAVI + MR undergoing TMVR/r

Patients undergoing TAVI with MR more than moderate following the procedure, underwent transcatheter mitral valve intervention

Device: TAVI; Device: TMVR/r

Interventions

TAVI DEVICE

Trascatheter aortic valve implantation

Also known as: TAVR

TAVI + MR no further intervention; TAVI + MR undergoing TMVR/r; TAVI no MR

TMVR/r DEVICE

Transcatheter mitral valve replacement/repair

TAVI + MR undergoing TMVR/r

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing TAVI who also have data regarding MR grade pre TAVI and at least 30 days post TAVI.

You may qualify if:

• For phase 1:
• TAVI+TMVR/r (either as a single or staged procedure).
• Follow up of at least 30 days post TMVR/r (unless deceased) Available TTE and/or TOE data pre and post TAVI + TMVR/r
• For phase 2:
• Patients undergoing successful isolated TAVI
• Assessment of MR grade prior and post TAVI

You may not qualify if:

• Death within 30 days post TAVI

Sponsors & Collaborators

• Rabin Medical Center: lead
• Clinique Pasteur: collaborator
• University of Catania: collaborator
• Montefiore Medical Center: collaborator
• University Medical Centre Ljubljana: collaborator
• University of Bonn: collaborator
• Medical University of Vienna: collaborator
• University Hospital, Antwerp: collaborator
• University of Padova: collaborator
• Erasmus Medical Center: collaborator
• Clinical Institute Saint Ambrogio, Milan: collaborator
• Hospital San Carlos, Madrid: collaborator
• McGill University: collaborator
• Mayo Clinic: collaborator
• IRCCS San Raffaele: collaborator
• IRCCS Policlinico S. Donato: collaborator
• Galway University Hospitals: collaborator
• Tel-Aviv Sourasky Medical Center: collaborator
• University Hospital Freiburg: collaborator
• Hadassah Medical Organization: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator
• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: collaborator
• Teikyo University: collaborator
• Rigshospitalet, Denmark: collaborator
• Cliniche Humanitas Gavazzeni: collaborator
• G. Pasquinucci Heart Hospital, Massa: collaborator
• Aarhus University Hospital: collaborator
• Royal Victoria Hospital, Belfast: collaborator
• University of British Columbia: collaborator
• Cardiovascular Center Frankfurt: collaborator

Study Sites (1)

Rabin Medical Center - Hsharon Campus

Petah Tikva, 49100, Israel

Location

Related Publications (15)

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  PMID: 27956264 RESULT

• Nombela-Franco L, Eltchaninoff H, Zahn R, Testa L, Leon MB, Trillo-Nouche R, D'Onofrio A, Smith CR, Webb J, Bleiziffer S, De Chiara B, Gilard M, Tamburino C, Bedogni F, Barbanti M, Salizzoni S, Garcia del Blanco B, Sabate M, Moreo A, Fernandez C, Ribeiro HB, Amat-Santos I, Urena M, Allende R, Garcia E, Macaya C, Dumont E, Pibarot P, Rodes-Cabau J. Clinical impact and evolution of mitral regurgitation following transcatheter aortic valve replacement: a meta-analysis. Heart. 2015 Sep;101(17):1395-405. doi: 10.1136/heartjnl-2014-307120. Epub 2015 Jun 9.

  PMID: 26060121 RESULT

• Shibayama K, Harada K, Berdejo J, Mihara H, Tanaka J, Gurudevan SV, Siegel R, Jilaihawi H, Makkar RR, Shiota T. Effect of transcatheter aortic valve replacement on the mitral valve apparatus and mitral regurgitation: real-time three-dimensional transesophageal echocardiography study. Circ Cardiovasc Imaging. 2014 Mar;7(2):344-51. doi: 10.1161/CIRCIMAGING.113.000942. Epub 2014 Jan 28.

  PMID: 24474596 RESULT

• Tsang W, Meineri M, Hahn RT, Veronesi F, Shah AP, Osten M, Nathan S, Russo M, Lang RM, Horlick EM. A three-dimensional echocardiographic study on aortic-mitral coupling in transcatheter aortic valve replacement. Eur Heart J Cardiovasc Imaging. 2013 Oct;14(10):950-6. doi: 10.1093/ehjci/jet058. Epub 2013 May 29.

  PMID: 23720379 RESULT

• Harling L, Saso S, Jarral OA, Kourliouros A, Kidher E, Athanasiou T. Aortic valve replacement for aortic stenosis in patients with concomitant mitral regurgitation: should the mitral valve be dealt with? Eur J Cardiothorac Surg. 2011 Nov;40(5):1087-96. doi: 10.1016/j.ejcts.2011.03.036. Epub 2011 May 14.

  PMID: 21570860 RESULT

• Nombela-Franco L, Ribeiro HB, Urena M, Allende R, Amat-Santos I, DeLarochelliere R, Dumont E, Doyle D, DeLarochelliere H, Laflamme J, Laflamme L, Garcia E, Macaya C, Jimenez-Quevedo P, Cote M, Bergeron S, Beaudoin J, Pibarot P, Rodes-Cabau J. Significant mitral regurgitation left untreated at the time of aortic valve replacement: a comprehensive review of a frequent entity in the transcatheter aortic valve replacement era. J Am Coll Cardiol. 2014 Jun 24;63(24):2643-58. doi: 10.1016/j.jacc.2014.02.573. Epub 2014 Mar 26.

  PMID: 24681140 RESULT

• Iung B, Baron G, Butchart EG, Delahaye F, Gohlke-Barwolf C, Levang OW, Tornos P, Vanoverschelde JL, Vermeer F, Boersma E, Ravaud P, Vahanian A. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J. 2003 Jul;24(13):1231-43. doi: 10.1016/s0195-668x(03)00201-x.

  PMID: 12831818 RESULT

• Bedogni F, Latib A, De Marco F, Agnifili M, Oreglia J, Pizzocri S, Latini RA, Lanotte S, Petronio AS, De Carlo M, Ettori F, Fiorina C, Poli A, Cirri S, De Servi S, Ramondo A, Tarantini G, Marzocchi A, Fiorilli R, Klugmann S, Ussia GP, Tamburino C, Maisano F, Brambilla N, Colombo A, Testa L. Response to letter regarding article, "Clinical impact of persistent left bundle-branch block after transcatheter aortic valve implantation with CoreValve revalving system". Circulation. 2013 Nov 26;128(22):e444. doi: 10.1161/CIRCULATIONAHA.113.005705. No abstract available.

  PMID: 24276881 RESULT

• Cortes C, Amat-Santos IJ, Nombela-Franco L, Munoz-Garcia AJ, Gutierrez-Ibanes E, De La Torre Hernandez JM, Cordoba-Soriano JG, Jimenez-Quevedo P, Hernandez-Garcia JM, Gonzalez-Mansilla A, Ruano J, Jimenez-Mazuecos J, Castrodeza J, Tobar J, Islas F, Revilla A, Puri R, Puerto A, Gomez I, Rodes-Cabau J, San Roman JA. Mitral Regurgitation After Transcatheter Aortic Valve Replacement: Prognosis, Imaging Predictors, and Potential Management. JACC Cardiovasc Interv. 2016 Aug 8;9(15):1603-14. doi: 10.1016/j.jcin.2016.05.025.

  PMID: 27491611 RESULT

• Chakravarty T, Van Belle E, Jilaihawi H, Noheria A, Testa L, Bedogni F, Ruck A, Barbanti M, Toggweiler S, Thomas M, Khawaja MZ, Hutter A, Abramowitz Y, Siegel RJ, Cheng W, Webb J, Leon MB, Makkar RR. Meta-analysis of the impact of mitral regurgitation on outcomes after transcatheter aortic valve implantation. Am J Cardiol. 2015 Apr 1;115(7):942-9. doi: 10.1016/j.amjcard.2015.01.022. Epub 2015 Jan 15.

  PMID: 25779617 RESULT

• Witberg G, Levi A, Talmor-Barkan Y, Barbanti M, Valvo R, Costa G, Frittitta V, de Backer O, Willemen Y, van den Dorpel M, Mon M, Sugiura A, Sudo M, Masiero G, Pancaldi E, Arzamendi D, Santos-Martinez S, Baz JA, Steblovnik K, Mauri V, Adam M, Wienemann H, Zahler D, Hein M, Ruile P, Aodha BN, Grasso C, Branca L, Estevez-Loureiro R, Amat-Santos IJ, Mylotte D, Bunc M, Tarantini G, Nombela-Franco L, Sondergaard L, Van Mieghem NM, Finkelstein A, Kornowski R. Outcomes and predictors of left ventricle recovery in patients with severe left ventricular dysfunction undergoing transcatheter aortic valve implantation. EuroIntervention. 2024 Apr 15;20(8):e487-e495. doi: 10.4244/EIJ-D-23-00948.

  PMID: 38629416 DERIVED

• Witberg G, Landes U, Talmor-Barkan Y, Richter I, Barbanti M, Valvo R, De Backer O, Ooms JF, Islas F, Marroquin L, Sedaghat A, Sugiura A, Masiero G, Armario X, Fiorina C, Arzamendi D, Santos-Martinez S, Fernandez-Vazquez F, Baz JA, Steblovnik K, Mauri V, Adam M, Merdler I, Hein M, Ruile P, Codner P, Grasso C, Branca L, Estevez-Loureiro R, Benito-Gonzalez T, Amat-Santos IJ, Mylotte D, Bunc M, Tarantini G, Nombela-Franco L, Sondergaard L, Van Mieghem NM, Finkelstein A, Kornowski R. Center Valve Preference and Outcomes of Transcatheter Aortic Valve Replacement: Insights From the AMTRAC Registry. JACC Cardiovasc Interv. 2022 Jun 27;15(12):1266-1274. doi: 10.1016/j.jcin.2022.05.004.

  PMID: 35738747 DERIVED

• Witberg G, Landes U, Codner P, Barbanti M, Valvo R, De Backer O, Ooms JF, McInerney A, Masiero G, Werner P, Armario X, Fiorina C, Arzamendi D, Santos-Martinez S, Baz JA, Steblovnik K, Mauri V, Adam M, Merdler I, Hein M, Ruile P, Russo M, Musumeci F, Sedaghat A, Sugiura A, Grasso C, Branca L, Estevez-Loureiro R, Amat-Santos IJ, Mylotte D, Andreas M, Bunc M, Tarantini G, Nombela-Franco L, Sondergaard L, Van Mieghem NM, Finkelstein A, Kornowski R. Clinical outcomes of transcatheter aortic valve implantation in patients younger than 70 years rejected for surgery: the AMTRAC registry. EuroIntervention. 2022 Mar 18;17(16):1289-1297. doi: 10.4244/EIJ-D-21-00613.

  PMID: 34673502 DERIVED

• Witberg G, Codner P, Landes U, Schwartzenberg S, Barbanti M, Valvo R, De Backer O, Ooms JF, Islas F, Marroquin L, Sedaghat A, Sugiura A, Masiero G, Werner P, Armario X, Fiorina C, Arzamendi D, Santos-Martinez S, Fernandez-Vazquez F, Baz JA, Steblovnik K, Mauri V, Adam M, Merdler I, Hein M, Ruile P, Grasso C, Branca L, Estevez-Loureiro R, Benito-Gonzalez T, Amat-Santos IJ, Mylotte D, Andreas M, Bunc M, Tarantini G, Sinning JM, Nombela-Franco L, Sondergaard L, Van Mieghem NM, Finkelstein A, Kornowski R. Effect of Transcatheter Aortic Valve Replacement on Concomitant Mitral Regurgitation and Its Impact on Mortality. JACC Cardiovasc Interv. 2021 Jun 14;14(11):1181-1192. doi: 10.1016/j.jcin.2021.02.030. Epub 2021 May 12.

  PMID: 33992550 DERIVED

• Witberg G, Codner P, Landes U, Barbanti M, Valvo R, De Backer O, Ooms JF, Sievert K, El Sabbagh A, Jimenez-Quevedo P, Brennan PF, Sedaghat A, Masiero G, Werner P, Overtchouk P, Watanabe Y, Montorfano M, Bijjam VR, Hein M, Fiorina C, Arzamendi D, Rodriguez-Gabella T, Fernandez-Vazquez F, Baz JA, Laperche C, Grasso C, Branca L, Estevez-Loureiro R, Benito-Gonzalez T, Amat Santos IJ, Ruile P, Mylotte D, Buzzatti N, Piazza N, Andreas M, Tarantini G, Sinning JM, Spence MS, Nombela-Franco L, Guerrero M, Sievert H, Sondergaard L, Van Mieghem NM, Tchetche D, Webb JG, Kornowski R. Transcatheter Treatment of Residual Significant Mitral Regurgitation Following TAVR: A Multicenter Registry. JACC Cardiovasc Interv. 2020 Dec 14;13(23):2782-2791. doi: 10.1016/j.jcin.2020.07.014.

  PMID: 33303117 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis; Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Ran Kornowski, MD

  Rabin Medical Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant cardiologist

Study Record Dates

• First Submitted: June 30, 2019
• First Posted: July 24, 2019
• Study Start: September 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: December 31, 2020
• Last Updated: July 24, 2019

Record last verified: 2019-07

Locations

IL (1)