Streamlined One-wire Logistics Optimize Transcatheter Aortic Valve Replacement

Обзор

The goal of this study is to determine the safety and performance of a new guidewire and pacing system called the Fusion System in treating patients undergoing transcatheter aortic valve replacement (TAVR) or similar procedures. The main questions it aims to answer are: Is the Fusion System safe? Is the Fusion System's clinical performance acceptable? Participants will asked to sign a study consent and report any adverse events experienced until they are discharged from hospital (or a maximum of 2 days following their procedure).

Вмешательства

• Устройство Aortic valve repair/replacement
  TAVR or valvuloplasty using the Fusion System for delivery of the treatment system and for temporary rapid pacing

Первичные конечные точки

• Transcatheter heart valve device migration/embolization or inability to complete BAV procedure. [Срок оценки: Intraprocedure]
• Successful deployment of THV or BAV system over the Fusion Guidewire [Срок оценки: Intraprocedure]

Критерии участия

Критерии включения

• Scheduled for a THV or BAV procedure in accordance with standard institutional protocols requiring temporary pacing.
• Willing and able to comply with the follow-up evaluations
• Been informed of the nature of the study, agrees to its provisions, and has provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)

Критерии исключения

• Undergoing an emergent procedure
• An ST elevation myocardial infarction (STEMI) within 7 days of procedure
• Had cardiac arrest within 7 days of procedure requiring CPR or defibrillation
• An indication to require mechanical cardiac support (MCS) post-procedure
• Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical circulatory support within 30 days prior to index procedure
• Active endocarditis within 30 days prior to index procedure
• Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
• Severe aortic annular or sub annular calcium per operator evaluation.
• Bicuspid aortic valve stenosis WITH severe raphe calcium per operator evaluation.
• Had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 90 days of index procedure
• Severe peripheral vascular disease that would preclude safe placement of an introducer sheath
• A planned alternative (i.e., non-femoral) access site
• A comorbidity that would preclude index procedure or use of the Solo Pace Fusion System
• A known, untreated neurological, psychological, psychiatric or other disorder that would interfere with trial endpoints or with cooperation with the requirements of the trial
• Participating in another investigational drug or device study
• Pregnant, lactating, or plan to become pregnant during the study (women of child-bearing potential must have a pregnancy test).

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.

Идентификаторы

NCT: NCT07090811 · 100288

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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