Prospective Multicenter Study Evaluating Myval TAVR Safety and Effectiveness in High-risk Severe AR

Официальное название

Prospective, Multicenter, Single-arm, Open-label Study Evaluating the Safety and Effectiveness of the Myval Transcatheter Heart Valve (THV) System in High-risk Patients With Severe Symptomatic Non- or Mildly Calcified Aortic Regurgitation.

Обзор

Prospective study is designed to evaluate the safety and efficacy of Myval THV series in patients with severe symptomatic non- or mild-calcified aortic regurgitation.

Подробное описание

Severe symptomatic aortic regurgitation (AR) in high-risk or inoperable patients with non- or mildly calcified valves has limited treatment options. While TAVR has emerged as a viable approach in aortic stenosis, its use in aortic regurgitation remains limited due to anatomical complexities, the absence of dedicated devices, and the prevalence of large annular dimensions in these patients.Dedicated devices like the JenaValve Trilogy™ demonstrated safety and efficacy in trials such as ALIGN-AR and JUPITER registry, but use is restricted by annular size limitations.Additionally, The PANTHEON International Project demonstrated safety and efficacy of balloon and self-expandable valves in severe AR patients. Despite improved THV platforms and techniques, TAVR for pure native aortic valve regurgitation remains a challenging procedure, with significant risk for transcatheter valve embolization or migration (TVEM).The Myval THV series offers a broader size range from 20mm-35mm and allows for controlled oversizing, as demonstrated in a large international registry showing high technical success and favorable 1-year outcomes in patients with non-calcified AR.

Вмешательства

• Устройство Myval THV series
  All patients with severe symptomatic non- or mild-calcified aortic regurgitation undergoing TAVR using Myval THV series in high surgical risk based on investigator/Heart team discretion who meet study eligibility criteria.

Первичные конечные точки

• All cause mortality [Срок оценки: 30 days]
• All Stroke [Срок оценки: 30 days]
• Bleeding (Type 3 & 4) [Срок оценки: 30 days]
• Major vascular complications [Срок оценки: 30 days]
• Acute Kidney Injury (Stage 3 and 4) [Срок оценки: 30 days]
• Surgery/Intervention related to device [Срок оценки: 30 days]
• Conduction system disturbances resulting in a new permanent pacemaker implantation [Срок оценки: 30 days]
• Greater than or equal to Moderate Paravalvular Regurgitation [Срок оценки: 30 days]

Вторичные конечные точки (12)

• All cause mortality [Срок оценки: 6 months, 1 year, 2 years, 3 years, 4 years and 5 years]
• All Stroke [Срок оценки: 1 years, 3 years and 5 years]
• Bleeding (Type 3 & 4) [Срок оценки: 1 year, 3 years and 5 years]
• Surgery/Intervention related to device [Срок оценки: 1 year, 3 years and 5 years]
• Conduction system disturbances resulting in a new permanent pacemaker implantation [Срок оценки: 1 year, 3 years and 5 years]
• Re-hospitalization for procedure-related or valve-related causes [Срок оценки: 30 days, 1 year, 3 years and 5 years]
• NYHA functional improvement [Срок оценки: 30 days, 1 year, 3 years and 5 years]
• Residual aortic regurgitation ≤ mild [Срок оценки: 30 days, 1 year, 3 years and 5 years]
• Six-minute walk test [Срок оценки: 30 days, 1 year, 3 years and 5 years]
• Evidence of bioprosthetic valve dysfunction and bioprosthetic valve failure [Срок оценки: 1 year, 3 year and 5 year]
• Bioprosthetic valve deterioration [Срок оценки: 1 year]
• Length of index hospital stay [Срок оценки: From procedure up to discharge, assessed until 2-3 days post procedure]

Критерии участия

Критерии включения

• Patient above 18 years of age.
• Patients must have co-morbidities such that the heart team and Investigator concur that the predicted risk of operative mortality is high.
• Patient has non- or mild-calcified aortic regurgitation, undergoing TAVI with Myval THV Series without any degree stenosis, and severe aortic regurgitation as per investigator/ Heart team discretion according to (at least one) imaging criteria that can include:

• Echocardiographically derived criteria: regurgitant volume ≥60 ml/beat, regurgitant fraction ≥50%, effective regurgitant orifice ≥0.3cm2, holodiastolic flow reversal at the level of the mid-descending aorta with an end diastolic flow velocity greater than 20 cm/s, width of vena contracta ≥6mm, hemi pressure time <200 msec, or vena contracta area assessed with 3D echo ≥0.4 cm².

AND/OR

• Cardiac magnetic resonance derived criteria: Regurgitant fraction >40% or regurgitant volume >60mL.
• Patient suitable for implantation with Myval THV series via transfemoral approach.
• Patient is symptomatic from his/her aortic valve regurgitation, as demonstrated by the New York Heart Association (NYHA) Functional Class ≥II.
• Patient or the patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee of the respective clinical site.
• The patient and the treating physician agree that the patient will return for all required post-procedure follow-up visits.

Критерии исключения

• Patients who are not willing to provide informed consent form, or whose legal heirs object to participate in the study
• Pregnant and lactating female patients
• Evidence of an acute myocardial infarction ≤1 month before the intended treatment
• Mixed aortic valve disease
• Moderate-severe calcification of aortic valve
• Bicuspid aortic valve disease according to treating physician (if detected by the corelab it will not be excluded except if so considered by the steering committee)
• Congenital unicuspid patients
• Any therapeutic invasive cardiac procedure performed within 30 days of the index procedure, (or 6 months if the procedure was a drug eluting coronary stent/scaffold implantation).
• Pre-existing prosthetic heart valve in any position, prosthetic ring, severe mitral annular calcification (MAC), severe (greater than 3+) mitral insufficiency, or Gorlin syndrome.
• Blood dyscrasias as defined: leukopenia (WBC<3000 mm3), acute anemia (Hb<9 mg/dl), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy.
• Untreated clinically significant coronary artery disease requiring revascularization.
• Hemodynamic instability requiring inotropic support or mechanical heart assistance.
• Need for emergency surgery other than aortic valve replacement with the study device.
• Hypertrophic cardiomyopathy with or without obstruction (HOCM).
• Very severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <15%.
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
• Active peptic ulcer or upper GI bleeding within the prior 3 months.
• A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media, which cannot be adequately premedicated.
• Recent (within 6 months) cerebrovascular accident (CVA) or a Transient Ischemic Attack (TIA).
• Renal insufficiency and/or end stage renal disease requiring chronic dialysis
• Life expectancy <1 year due to non-cardiac co-morbid conditions.
• Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5cm or greater; marked tortuosity (hyperacute bend), aortic arch atheroma or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta (applicable for transfemoral patients only) which would make Transcatheter Aortic Valve Implantation (TAVI) unfeasible as per the Investigator/Heart Team.
• Iliofemoral vessel characteristics that would preclude safe placement of introducer sheath such as severe obstructive calcification, severe tortuosity or vessels with adequate femoral size (applicable for transfemoral patients only).
• Currently participating in an investigational drug or another device study which has not achieved the primary endpoint.
• Active bacterial endocarditis or other active infections.
• Any condition, which in the Investigator's opinion, would preclude safe participation of patient in the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Shelkey M, Wallace M. Katz Index of Independence in Activities of Daily Living (ADL). Director. 2000 Spring;8(2):72-3. No abstract available. PMID 11081028
• Corrigendum to: 2021 ESC/EACTS Guidelines for the management of valvular heart disease: Developed by the Task Force for the management of valvular heart disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2022 Jun 1;43(21):2022. doi: 10.1093/eurheartj/ehac051. No abstract available. PMID 35188539
• ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. PMID 12091180
• De Backer O, Pilgrim T, Simonato M, Mackensen GB, Fiorina C, Veulemanns V, Cerillo A, Schofer J, Amabile N, Achkouty G, Schafer U, Deutsch MA, Sinning JM, Rahman MS, Sawaya FJ, Hildick-Smith D, Hernandez JM, Kim WK, Lefevre T, Seiffert M, Bleiziffer S, Petronio AS, Van Mieghem N, Taramasso M, Sondergaard L, Windecker S, Latib A, Dvir D. Usefulness of Transcatheter Aortic Valve Implantation for Tre PMID 30072124
• Sawaya FJ, Deutsch MA, Seiffert M, Yoon SH, Codner P, Wickramarachchi U, Latib A, Petronio AS, Rodes-Cabau J, Taramasso M, Spaziano M, Bosmans J, Biasco L, Mylotte D, Savontaus M, Gheeraert P, Chan J, Jorgensen TH, Sievert H, Mocetti M, Lefevre T, Maisano F, Mangieri A, Hildick-Smith D, Kornowski R, Makkar R, Bleiziffer S, Sondergaard L, De Backer O. Safety and Efficacy of Transcatheter Aortic Val PMID 28521923
• Yoon SH, Schmidt T, Bleiziffer S, Schofer N, Fiorina C, Munoz-Garcia AJ, Yzeiraj E, Amat-Santos IJ, Tchetche D, Jung C, Fujita B, Mangieri A, Deutsch MA, Ubben T, Deuschl F, Kuwata S, De Biase C, Williams T, Dhoble A, Kim WK, Ferrari E, Barbanti M, Vollema EM, Miceli A, Giannini C, Attizzani GF, Kong WKF, Gutierrez-Ibanes E, Jimenez Diaz VA, Wijeysundera HC, Kaneko H, Chakravarty T, Makar M, Sieve PMID 29191323
• Elkoumy A, Jose J, Gunasekaran S, Kumar A, Srinivas BC, Manjunath CN, Ravindranath KS, Parekh M, Chandra P, Kapoor R, Abdelshafy M, Seth A, Agrawal P, Mathur A, Rao RS, Elzomor H, Sadanada KS, Kumar V, Arsang-Jang S, Mehrotra S, Raghuraman B, Khanolkar U, Premchand RK, Chopra M, Krishna P, Mehta H, Gupta R, Kumar V, Senguttuvan NB, Baumbach A, Serruys PW, Soliman O. Angiographic quantification of PMID 37028710
• Poletti E, De Backer O, Scotti A, Costa G, Bruno F, Fiorina C, Buzzatti N, Latini A, Rudolph TK, van den Dorpel MMP, Brinkmann C, Patel KP, Panoulas V, Schofer J, Giordano A, Barbanti M, Regazzoli D, Taramasso M, Saia F, Baumbach A, Maisano F, Van Mieghem NM, Sondergaard L, Latib A, Amat Santos IJ, Bedogni F, Testa L. Transcatheter Aortic Valve Replacement for Pure Native Aortic Valve Regurgitatio PMID 37648345

Идентификаторы

NCT: NCT07751965 · MYV/MARVEL TAVI-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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