Cardiac Implantable Electronic Device- Induced Remodelling of Tricuspid Valve and Right Chambers

Обзор

This single-center longitudinal study aims to evaluate the occurrence and clinical impact of tricuspid regurgitation (TR) after cardiac-implanted-electronic-device (CIED) implantation by comprehensive echocardiographic assessment, including advanced three-dimensional (3D) transthoracic and transesophageal imaging. The primary objective of this study is to assess the prevalence and leading mechanism of new or worsening TR, defined as an increase of at least one grade on a five-grade scale, after new CIED implantation. Secondary objectives include clinical and echocardiographic endpoints at discharge, three months, one year, and annually for up to five years. They can be summarized as follows: 1. to evaluate morphological and functional changes (remodeling) of the tricuspid valve (TV) apparatus and right-sided heart chambers in patients undergoing new CIED implantation. 2. to identify risk factors for new or worsening TR after CIED implantation on an anatomical, procedural, and clinical level. 3. to determine the clinical impact of new or worsening TR after CIED implantation. 4. to explore the treatment strategies for lead-related TR (observational).

Первичные конечные точки

• Change in TR at least one grade after new CIED implantation [Срок оценки: 5 years]

Вторичные конечные точки (4)

• Incidence of mortality (all-cause, cardiovascular, non-cardiovascular) [Срок оценки: 5 years]
• Incidence of heart failure Hospitalization or any change in diuretic dosage or need for intravenous diuretics [Срок оценки: 1 year, and annually through 5 years]
• New York Heart Association (NYHA) functional class [Срок оценки: at 1 day, 3 months, 1 year, and annually through 5 years]
• Incidence of tricuspid valve intervention (either transcatheter or surgical) [Срок оценки: 1 year, and annually through 5 years]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Patient able and willing to give informed consent in written form before the index procedure
• Patient understands the purpose, the potential risks as well as benefits of the study and is willing to participate in all parts of the follow-up
• Patients undergoing any new CIED implantation with or without transvalvular lead
• Sufficient imaging quality on transthoracic echocardiography to assess TR severity grade and morphology of right-sided heart chambers

Критерии исключения

• Previous or present CIED
• Life expectancy < 12 months due to non-cardiac condition
• Tricuspid valve stenosis of any severity or severe TR planned for intervention (transcatheter, surgical) within the next 12 months
• Previous tricuspid valve intervention (transcatheter, surgical)
• Participation in another study, which would lead to deviations from this trial protocol

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• San Luca Hospital — Milan

Публикации

• Seo J, Kim DY, Cho I, Hong GR, Ha JW, Shim CY. Prevalence, predictors, and prognosis of tricuspid regurgitation following permanent pacemaker implantation. PLoS One. 2020 Jun 26;15(6):e0235230. doi: 10.1371/journal.pone.0235230. eCollection 2020. PMID 32589674
• Kanawati J, Ng ACC, Khan H, Yu C, Hyun K, Abed H, Kritharides L, Sy RW. Long-Term Follow-Up of Mortality and Heart Failure Hospitalisation in Patients With Intracardiac Device-Related Tricuspid Regurgitation. Heart Lung Circ. 2021 May;30(5):692-697. doi: 10.1016/j.hlc.2020.08.028. Epub 2020 Oct 31. PMID 33132050
• Papageorgiou N, Falconer D, Wyeth N, Lloyd G, Pellerin D, Speechly-Dick E, Segal OR, Lowe M, Rowland E, Lambiase PD, Chow AW, Bhattacharyya S. Effect of tricuspid regurgitation and right ventricular dysfunction on long-term mortality in patients undergoing cardiac devices implantation: >10-year follow-up study. Int J Cardiol. 2020 Nov 15;319:52-56. doi: 10.1016/j.ijcard.2020.05.062. Epub 2020 May PMID 32470533
• Delling FN, Hassan ZK, Piatkowski G, Tsao CW, Rajabali A, Markson LJ, Zimetbaum PJ, Manning WJ, Chang JD, Mukamal KJ. Tricuspid Regurgitation and Mortality in Patients With Transvenous Permanent Pacemaker Leads. Am J Cardiol. 2016 Mar 15;117(6):988-92. doi: 10.1016/j.amjcard.2015.12.038. Epub 2016 Jan 6. PMID 26833208
• Al-Bawardy R, Krishnaswamy A, Rajeswaran J, Bhargava M, Wazni O, Wilkoff B, Tuzcu EM, Martin D, Thomas J, Blackstone E, Kapadia S. Tricuspid regurgitation and implantable devices. Pacing Clin Electrophysiol. 2015 Feb;38(2):259-66. doi: 10.1111/pace.12530. Epub 2014 Nov 7. PMID 25377489
• Hoke U, Auger D, Thijssen J, Wolterbeek R, van der Velde ET, Holman ER, Schalij MJ, Bax JJ, Delgado V, Marsan NA. Significant lead-induced tricuspid regurgitation is associated with poor prognosis at long-term follow-up. Heart. 2014 Jun;100(12):960-8. doi: 10.1136/heartjnl-2013-304673. Epub 2014 Jan 21. PMID 24449717
• Baquero GA, Yadav P, Skibba JB, Banchs JE, Linton-Frazier LN, Lengerich EJ, Samii SM, Penny-Peterson E, Wolbrette DL, Luck JC, Naccarelli GV, Gonzalez MD. Clinical significance of increased tricuspid valve incompetence following implantation of ventricular leads. J Interv Card Electrophysiol. 2013 Dec;38(3):197-202. doi: 10.1007/s10840-013-9826-2. PMID 24022757

Идентификаторы

NCT: NCT06914570 · 09C407

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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