Definition and Prognosis of Atrioventricular Regurgitation in Transthyretin Amyloid Cardiomyopathy - a Prospective International Multicenter Study
Sponsor study identifier
observational
600
4 countries
8
Study Start
January 1, 2025
Actual (reported)Primary Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The objective of this prospective registry study is to comprehensively characterize the prevalence, (semi-) quantitative parameters, and associated clinical outcomes of mitral (MR) and tricuspid regurgitation (TR) in patients diagnosed with transthyretin amyloid cardiomyopathy (ATTR-CM). The study further aims to develop and implement new grading standards for the quantitative assessment of regurgitation severity, tailored to the distinct hemodynamic profile of ATTR-CM. This approach seeks to address the limitations of current regurgitation severity classifications, which do not adequately reflect the unique pathophysiology of a restrictive phenotype as seen in ATTR-CM.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2025
Actual (reported)February 14, 2025
Actual (reported)February 19, 2025
Actual (reported)December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
All-cause mortality
Assessment of all-cause mortality in patients with ATTR-CM, stratified by baseline quantitative and semiquantitative measures of mitral and tricuspid regurgitation severity
up to 60 months
Cardiovscular mortality
up to 60 months
Heart Failure Hospitalization
up to 60 months
This observational study will include patients diagnosed with transthyretin amyloid cardiomyopathy (ATTR-CM) from international specialized cardiac amyloidosis referral centers. The study population will encompass both wild-type and hereditary ATTR-CM patients, ensuring representation of diverse disease phenotypes. Data collection will be standardized across centers, with echocardiographic assessments performed in accordance with the dedicated study protocol. The inclusion of multiple international centers will enhance the generalizability of findings across different healthcare systems and patient populations.
Medical University of Graz
Graz, Styria, 8010, Austria
Department of Internal Medicine II, Medical University of Vienna
Vienna, 1090, Austria
Dona C, Nitsche C, Koschutnik M, Heitzinger G, Mascherbauer K, Kammerlander AA, Dannenberg V, Halavina K, Rettl R, Duca F, Traub-Weidinger T, Puchinger J, Gunacker PC, Lamm G, Vock P, Lileg B, Philipp V, Staudenherz A, Calabretta R, Hacker M, Agis H, Bartko P, Hengstenberg C, Fontana M, Goliasch G, Mascherbauer J. Unveiling Cardiac Amyloidosis, its Characteristics, and Outcomes Among Patients With MR Undergoing Transcatheter Edge-to-Edge MV Repair. JACC Cardiovasc Interv. 2022 Sep 12;15(17):1748-1758. doi: 10.1016/j.jcin.2022.06.009. Epub 2022 Aug 22.
Hauptmann L, Kronberger C, Schwarting SK, Tomasoni D, Schlender LS, Koschatko S, Autherith M, Jantsch C, Demirel C, Duca F, Kammerlander A, Bordignon L, Guidi Colombi G, Schwegel N, Serenelli M, Porcari A, Muller SA, Verheyen N, Oerlemans MIFJ, Papathanasiou M, Hengstenberg C, Merlo M, Hausleiter J, Adamo M, Bartko PE, Nitsche C. Definition and Prognosis of Mitral Regurgitation in Transthyretin Amyloid Cardiomyopathy: A Multicenter International Cohort Study. Circulation. 2026 Oct 13. doi: 10.1161/CIRCULATIONAHA.125.079085. Online ahead of print.
First Submitted
February 14, 2025
First Posted
February 19, 2025
Study Start
January 1, 2025
Actual (reported)Primary Completion
December 31, 2025
Estimated (date passed)Double Transseptal Guide Sheath to Prevent Dock Drop During SAPIEN M3 Transcatheter Mitral Valve Replacement
Progression of Atrioventricular Regurgitation
At 12 and 24 months follow-up
Contact the study team to confirm eligibility.
Medizinische Klinik und Poliklinik I, Klinikum der Universitaet Muenchen, Ludwig-Maximilians-University
Munich, Bavaria, 81377, Germany
Department of Cardiology, University Hospital Frankfurt, Goethe University
Frankfurt am Main, Hesse, 60596, Germany
Institute of Cardiology, ASST Spedali Civili di Brescia, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia
Brescia, 25100, Italy
Cardiologic Centre, Azienda Ospedaliero Universitaria di Ferrara
Ferrara, 44121, Italy
Center for Diagnosis and Treatment of Cardiomyopathies, Cardiovascular Department, Azienda Sanitaria Universitaria Giuliano-Isontina (ASUGI), University of Trieste
Trieste, 34100, Italy
University Medical Center Utrecht
Utrecht, 3450, Netherlands
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 19, 2025
Record last verified: 2025-02
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