Идёт набор NCT05711186

Structured Shared Decision Making for Patients Undergoing SAVR or TAVR

Без фазы С лечением Aortic Valve Stenosis Symptomatic Aortic Stenosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Structured SDM, Usual Care.
Кому может быть актуально: Состояния в реестре: Aortic Valve Stenosis, Symptomatic Aortic Stenosis. Базовые параметры: от 70 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Швейцария
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Structured Shared Decision Making for Patients Undergoing Elective Surgical or Transcatheter Aortic Valve Replacement (TOGETHER): A Randomized-controlled Trial

Обзор

Transcatheter aortic valve replacement (TAVR) is a well-established alternative to surgical aortic valve replacement (SAVR) for the treatment of patients with severe aortic stenosis regardless of surgical risk. While TAVR and SAVR share some of the benefits and risks, they importantly differ with regards to invasiveness, time to recovery, hemodynamics, as well as options for re-intervention and possibly valve durability. An early benefit of TAVR may be offset by late risks. Therefore, current guidelines of the European Society of Cardiology recommend an integration of patient values and preferences for the selection of the treatment modality. The objective of the TOGETHER trial is to investigate the efficacy of a structured shared decision making approach (SDM) to improve patient-centered outcomes for the choice between SAVR and TAVR. TOGETHER is an investigator-initiated, randomized, open-label, single-center clinical trial. A total of 140 patients referred for treatment of symptomatic severe aortic stenosis and deemed to undergo TAVR or SAVR according to heart team decision will be randomized in a 1:1 ratio to structured SDM or usual care.

Вмешательства

Другое Structured SDM
The conversation between the heart team member and the patient will be structured according the adapted three-talk model for patients with symptomatic aortic stenosis and using the American College of Cardiology's decision aid for patients deciding between TAVR and SAVR
Другое Usual Care
Usual care will include baseline visits without a structured SDM approach. Usual care includes at least one decision making talk with a heart team member discussing information about the disease, treatment options as well as benefits and risks of each procedure.

Первичные конечные точки

Patient decisional conflict [Срок оценки: 3 days post baseline visit]
Patient decisional regret [Срок оценки: 30 days post TAVR/SAVR]

Вторичные конечные точки (11)

Patient-centered communication [Срок оценки: 3 days post baseline visit]
Patient knowledge about the treatment options and outcomes [Срок оценки: 3 days post baseline visit]
Patient procedural satisfaction [Срок оценки: 3 days post baseline visit]
Patient decisional satisfaction [Срок оценки: 3 days post baseline visit; 30 days and 1 year post TAVR/SAVR]
Incorporation of patient values [Срок оценки: 3 days post baseline visit]
Patient feeling of not being informed [Срок оценки: 3 days post baseline visit]
Quality of choice [Срок оценки: 3 days post baseline visit]
Patient decisional regret [Срок оценки: 1 year post TAVR/SAVR]
Patient health-related quality of life [Срок оценки: 30 days post TAVR/SAVR]
The proportion of patients choosing TAVR/SAVR [Срок оценки: Baseline]
The incidences of major clinical adverse events [Срок оценки: 30 days and 1 year post TAVR/SAVR]

Критерии участия

Критерии включения

Age ≥ 70 years
Symptomatic severe aortic stenosis defined by an aortic valve area ≤1.0 cm2 or an aortic valve area indexed to body surface area <0.6cm2/m2
Both SAVR and transfemoral TAVR as reasonable treatment options based on heart team decision