Treating Severe Mitral Valve Annular or Valvular Calcification Using Shockwave Balloon SMARTWAVE

Официальное название

Mitral Valve Lithotripsy Using the SMARTWAVE Balloon for Severe Mitral Annular or Valvular Calcification (SMART-MAC): First in Human Study

Обзор

Mitral stenosis (MS) is a heavily symptomatic valvular heart disease. Common causes of MS included chronic rheumatic heart disease (CRHD) and mitral annular calcification (MAC). Current guideline recommends percutaneous balloon mitral valvuloplasty (PBMV) being the first line intervention for rheumatic MS with favorable anatomy. However, severely calcified mitral valve (i.e. those with Wilkins scores\>8) makes the mitral valve non-pliable and carries high risk of severe mitral regurgitation (MR) (4-19%) with conventional balloon valvuloplasty. MAC is an increasingly recognized disease associated with atherosclerotic risk factors, and a well-recognized valve morphology that responses poorly with PBMV. Besides, conventional open-heart surgery for MAC-associated mitral valve dysfunction carries high mortality. Transcatheter mitral valve replacement with valve-in-MAC has become an alternative in treating these patients. However, valve-in-MAC is not always feasible and still carries operative and 30-day mortality. Intravascular lithotripsy is an approved adjunct interventional therapy in treating calcified lesions to facilitate stenotic lesion opening in peripheral vascular disease and coronary artery disease. The off-label use of current peripheral lithotripsy balloon in mitral valve as a compassionate treatment or as an adjunct treatment before mitral balloon valvuloplasty and transcatheter mitral valve replacement has been reported with success . A possible mechanism is that lithotripsy preferentially impacts hard tissue, disrupts calcium, and leaves soft tissue undisturbed, improving valve pliability, preventing leaflet damage, and making subsequent valvuloplasty safer. However, the off-label use of multiple peripheral lithotripsy balloons in mitral valve is technically complicated. SmartWave balloon was specifically designed lithotripsy balloon for calcified aortic stenosis. This first-in-human study aims to apply the SmartWave lithotripsy balloon in treating calcified mitral stenosis due to MAC or severely calcified rheumatic mitral valve.

Подробное описание

Mitral stenosis (MS) is a heavily symptomatic valvular heart disease. Common causes of MS included chronic rheumatic heart disease (CRHD) and mitral annular calcification (MAC). Current guideline recommends percutaneous balloon mitral valvuloplasty (PBMV) being the first line intervention for rheumatic MS with favorable anatomy. However, severely calcified mitral valve (i.e. those with Wilkins scores\>8) makes the mitral valve non-pliable and carries high risk of severe mitral regurgitation (MR) (4-19%) with conventional balloon valvuloplasty. MAC is an increasingly recognized disease associated with atherosclerotic risk factors, and a well-recognized valve morphology that responses poorly with PBMV. Besides, conventional open-heart surgery for MAC-associated mitral valve dysfunction carries high mortality. Transcatheter mitral valve replacement with valve-in-MAC has become an alternative in treating these patients. However, valve-in-MAC is not always feasible and still carries operative and 30-day mortality.

Intravascular lithotripsy is an approved adjunct interventional therapy in treating calcified lesions to facilitate stenotic lesion opening in peripheral vascular disease and coronary artery disease. The off-label use of current peripheral lithotripsy balloon in mitral valve as a compassionate treatment or as an adjunct treatment before mitral balloon valvuloplasty and transcatheter mitral valve replacement has been reported with success . A possible mechanism is that lithotripsy preferentially impacts hard tissue, disrupts calcium, and leaves soft tissue undisturbed, improving valve pliability, preventing leaflet damage, and making subsequent valvuloplasty safer. However, the off-label use of multiple peripheral lithotripsy balloons in mitral valve is technically complicated.

SmartWave balloon was specifically designed lithotripsy balloon for calcified aortic stenosis. This first-in-human study aims to apply the SmartWave lithotripsy balloon in treating calcified mitral stenosis due to MAC or severely calcified rheumatic mitral valve.

Вмешательства

• Устройство SmartWave Lithotripsy balloon
  ntravascular lithotripsy is an approved adjunct interventional therapy in treating calcified lesions to facilitate stenotic lesion opening in peripheral vascular disease and coronary artery disease. The off-label use of current peripheral lithotripsy balloon in mitral valve as a compassionate treatment or as an adjunct treatment before mitral balloon valvuloplasty and transcatheter mitral valve replacement has been reported with success . A possible mechanism is that lithotripsy preferentially i

Первичные конечные точки

• Improvement in mitral valve area [Срок оценки: Post-OP 6 and 12 month]
• Absence of peri-procedural complication [Срок оценки: At and peri-procedure]

Вторичные конечные точки (8)

• Hemodynamic changes [Срок оценки: Intra-operation]
• Mitral valve calcification level [Срок оценки: Baseline and post-procedure up to 1 year]
• Symptom status change (New York Heart Aassociation functional class) [Срок оценки: Baseline,Post-OP 1 month, 3 month, 6 month, 12 month]
• Symptom status change (By Kansas City Cardiomyopathy Questionnaire-12) [Срок оценки: Baseline,Post-OP 1 month, 3 month, 6 month, 12 month]
• Debris histology [Срок оценки: peri-operation]
• NTproBNP [Срок оценки: baseline, post-operation, Post-OP 1, 3, 6, 12 month]
• Lung Fluid [Срок оценки: baseline, Post-OP 1, 3, 6, 12 month]
• Major Adverse Cardiac Event [Срок оценки: 6 month and 12 month post-operation]

Критерии участия

Критерии включения

• Age >18 and
• Able to give procedure and study consent and
• Severe symptomatic mitral stenosis (MVA <1.5cm\^2 derived by 3D planimetry or continuity equation or pressure half time) and
• Presence of mitral annular calcification or
• CRHD with severe leaflet calcification with Wilkins score >8

Критерии исключения

• Baseline > moderate MR
• Intracardiac thrombus as visualized by TEE
• Pregnant patients. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to index procedure.
• Active infection with bacteremia
• Current participation in another investigational drug or device 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

Гонконг · 1 центр

• Prince of Wales Hospital — Shatin

Публикации

• Stone GW, Adams DH, Abraham WT, Kappetein AP, Genereux P, Vranckx P, Mehran R, Kuck KH, Leon MB, Piazza N, Head SJ, Filippatos G, Vahanian AS; Mitral Valve Academic Research Consortium (MVARC). Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 2: Endpoint Definitions: A Consensus Document From the Mitral Valve Academic Research Co PMID 26184623
• Giustino G, Fang JX, Villablanca PA, Wang DD, Sturla N, Lee JC, O'Neill BP, Frisoli T, O'Neill WW, Engel-Gonzalez P. Intravascular Lithotripsy-Facilitated Balloon Valvuloplasty for Severely Calcified Mitral Valve Stenosis. JACC Cardiovasc Interv. 2024 Jan 22;17(2):326-327. doi: 10.1016/j.jcin.2023.10.015. Epub 2023 Dec 20. No abstract available. PMID 38127026
• Sharma A, Kelly R, Mbai M, Chandrashekhar Y, Bertog S. Transcatheter Mitral Valve Lithotripsy as a Pretreatment to Percutaneous Balloon Mitral Valvuloplasty for Heavily Calcified Rheumatic Mitral Stenosis. Circ Cardiovasc Interv. 2020 Jul;13(7):e009357. doi: 10.1161/CIRCINTERVENTIONS.120.009357. Epub 2020 Jul 17. No abstract available. PMID 32674681
• Eng MH, Villablanca P, Wang DD, Frisoli T, Lee J, O'Neill WW. Lithotripsy-Facilitated Mitral Balloon Valvuloplasty for Senile Degenerative Mitral Valve Stenosis. JACC Cardiovasc Interv. 2019 Aug 12;12(15):e133-e134. doi: 10.1016/j.jcin.2019.05.026. Epub 2019 Jul 17. No abstract available. PMID 31326427
• Tepe G, Brodmann M, Werner M, Bachinsky W, Holden A, Zeller T, Mangalmurti S, Nolte-Ernsting C, Bertolet B, Scheinert D, Gray WA; Disrupt PAD III Investigators. Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Randomized Disrupt PAD III Trial. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1352-1361. doi: 10.1016/j.jcin.2021.04.010. PMID 34167675
• Rodriguez-Leor O, Cid-Alvarez AB, Lopez-Benito M, Gonzalo N, Vilalta V, Diarte de Miguel JA, Lopez LF, Jurado-Roman A, Diego A, Oteo JF, Cuellas C, Trillo R, Travieso A, Alfonso F, Carrillo X, Vegas-Valle JM, Cortes-Villar C, Pascual I, Munoz Camacho JF, Flores X, Vera-Vera S, Moreu J, Barreira de Sousa G, Marti D, Jimenez-Mazuecos J, Fuertes M, Ocaranza R, de la Torre Hernandez JM, Lozano F, Sola PMID 38385926
• Kereiakes DJ, Hill JM, Shlofmitz RA, Klein AJ, Riley RF, Price MJ, Herrmann HC, Bachinsky W, Waksman R, Stone GW; Disrupt CAD III Investigators. Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Arteries: 2-Year Results-Disrupt CAD III Study. JACC Cardiovasc Interv. 2023 Oct 9;16(19):2472-2474. doi: 10.1016/j.jcin.2023.07.010. Epub 2023 Sep 6. No abstract available. PMID 37676225
• Ali ZA, Kereiakes D, Hill J, Saito S, Di Mario C, Honton B, Gonzalo N, Riley R, Maehara A, Matsumura M, Stone GW, Shlofmitz R. Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Calcified Nodules. JACC Cardiovasc Interv. 2023 May 8;16(9):1122-1124. doi: 10.1016/j.jcin.2023.02.015. Epub 2023 Apr 5. No abstract available. PMID 37029020

Идентификаторы

NCT: NCT06952374 · 2024.362

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗