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TORCH-LATAM-004: Regional Advanced-Therapy Pathways for Adults With Acquired or Structural Heart Disease (TORCH-004)

11 сентября 2026 г. обновлено: CardioVision International Tech, S.A.S. de C.V.

A Stepped-Wedge Cluster Randomized Trial of the TORCH Adult Advanced Therapies Pathway for Adults With Advanced Heart Failure Secondary to Acquired or Structural Heart Disease in Latin America

TORCH-LATAM-004 is a pragmatic stepped-wedge cluster randomized trial evaluating a regional pathway for adults with advanced heart failure secondary to acquired or structural heart disease who may require heart or combined transplantation, mechanical circulatory or extracorporeal support, advanced structural intervention, or another regulated advanced-therapy pathway. Clusters transition from usual local pathways to TORCH-AATP. The primary outcome is completion of the prespecified multidisciplinary evaluation and documentation of an advanced-pathway decision within 90 days after enrollment. The study also evaluates barriers, authorized pathway or waiting-list activation, longitudinal status, mechanical support, definitive therapy, external regulated pathways, and clinical outcomes. Donor-organ and matching events are captured only where legally authorized and do not replace national allocation systems or transplant-center decisions.

Обзор исследования

Статус

Еще не набирают

Условия

Вмешательство/лечение

Подробное описание

Each TORCH regional network cluster is anchored in an authorized advanced-therapy or transplant center and may include activated evaluation, referral, advanced-heart-failure, structural-heart, intensive-care, mechanical-support, donor-origin, procurement, preservation, logistics, and data-coordination nodes. Adults with advanced heart failure secondary to acquired or structural heart disease may be identified at transplanting or non-transplanting centers when an authorized route to specialized evaluation exists. Authorized centers and competent authorities retain all legal and clinical authority for advanced-therapy candidacy, waiting-list activation, organ acceptance, allocation, and transplantation.

The recipient pathway records identification, referral, enrollment, completion of multidisciplinary adult evaluation, a documented advanced-pathway decision, barrier management, activation of an authorized pathway or official waiting list, longitudinal clinical and support status, transplantation, advanced structural intervention, regulated external-protocol enrollment, or an alternative outcome. Study enrollment is analytically distinct from advanced-therapy candidacy and official wait-list status.

The pathway permits clinically documented redirection among heart or combined transplantation; temporary or durable mechanical support; advanced structural intervention; recovery; surveillance; palliative care; and independently governed investigational protocols. TORCH does not assign an investigational drug, device, cell, organoid, xenograft, or other experimental therapy and does not infer efficacy or safety for such products.

Where legally authorized, donor-organ and recipient pathways converge at traceable compatibility and offer episodes. Each decision, non-acceptance reason, reassignment, urgency change, distance, logistics constraint, and final disposition is time-stamped. TORCH does not create a supranational allocation authority or override governmental or institutional systems.

Interoperability may range from audited manual transfer to structured documents, batch exchange, application programming interfaces, standards-based exchange, or validated remote-monitoring devices. Cross-border activity is activated only after applicable ethical, regulatory, institutional, data-protection, financial, and operational approvals.

Тип исследования

Интервенционный

Регистрация (Оцененный)

360

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Eliecer Villamizar De La Hoz, MD
  • Номер телефона: +50370878226
  • Электронная почта: eliecerevillamizar@gmail.com

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

Inclusion Criteria:

  • Adult aged 18 years or older at informed consent.
  • Documented acquired or structural heart disease with advanced heart failure meeting a protocol-defined trigger for specialized advanced-therapy evaluation.
  • Identification within an activated TORCH network cluster with an operational route to at least one authorized advanced-therapy or transplant center.
  • Ability to complete protocol-defined follow-up directly or through an authorized network pathway.
  • Provision of informed consent according to applicable requirements.

Exclusion Criteria:

  • Congenital heart disease as the primary condition, or absence of a documented pathophysiological relationship between acquired or structural heart disease and advanced heart failure.
  • No authorized route for protocol evaluation or follow-up at the time of enrollment.
  • Unable or unwilling to provide informed consent when required.
  • The prespecified multidisciplinary evaluation and advanced-pathway decision were already completed and remain clinically current before enrollment.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Исследования в области здравоохранения
  • Распределение: Рандомизированный
  • Интервенционная модель: Последовательное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: TORCH-AATP Intervention Period
Participants enrolled while their cluster is assigned to the intervention period receive the TORCH Adult Advanced Therapies Pathway, including protocolized identification and referral, multidisciplinary evaluation, pathway-decision adjudication, barrier navigation, pathway and waiting-list status tracking, and traceable donor-organ opportunity coordination when applicable.
Другой: TORCH Adult Advanced Therapies Pathway (TORCH-AATP)
A multicomponent health-services pathway that standardizes identification, referral, multidisciplinary adult advanced-heart-failure evaluation, advanced-pathway decision documentation, barrier navigation, longitudinal waiting-list and support status, authorized donor-organ and matching traceability, and secure information exchange. It does not assign organs, authorize therapies, or replace transplant-center or governmental decisions.
Без вмешательства: Usual Local Pathway Period
Participants enrolled before their cluster transitions to TORCH-AATP receive locally available referral, evaluation, treatment, support, structural-heart, and transplant-candidacy processes. Study data collection does not alter the authority of local programs or competent authorities.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Completion of Multidisciplinary Adult Advanced-Therapy Evaluation and Documented Pathway Decision Within 90 Days
Временное ограничение: Within 90 days after enrollment.
Percentage of eligible enrolled participants who complete the prespecified multidisciplinary adult advanced-therapy evaluation and have a documented advanced-pathway decision within 90 days after enrollment. APD-A, APD-B, APD-D, APD-E, APD-F, APD-G, and APD-H count as completed decisions when the minimum evaluation is complete. APD-C denotes incomplete evaluation and is not counted as success. Death, irreversible deterioration, or missing evidence before day 90 is not counted as success unless the minimum evaluation and a valid decision were documented.
Within 90 days after enrollment.

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Activation of an Authorized Advanced-Therapy Pathway or Official Waiting List
Временное ограничение: Within 180 days after the first documented advanced-pathway decision qualifying for activation.
Percentage of participants with a qualifying advanced-pathway decision who achieve documented activation of an authorized pathway or official waiting list. Enrollment alone is not activation.
Within 180 days after the first documented advanced-pathway decision qualifying for activation.
Time to Completed Multidisciplinary Evaluation and Advanced-Pathway Decision
Временное ограничение: From enrollment to completed evaluation and documented advanced-pathway decision, assessed through 180 days.
Time from enrollment to completion of the prespecified multidisciplinary adult evaluation and documentation of a valid advanced-pathway decision.
From enrollment to completed evaluation and documented advanced-pathway decision, assessed through 180 days.
Redirection of the Advanced-Therapy Pathway
Временное ограничение: Through 24 months after enrollment.
Percentage of enrolled participants with a documented change in intended advanced therapy or destination pathway, with origin, destination, authority, and reason recorded.
Through 24 months after enrollment.
Waiting-List Status or Urgency Transition
Временное ограничение: At each documented waiting-list transition through 24 months after enrollment.
Number and distribution of documented waiting-list status or urgency transitions by reason among participants with an official waiting-list episode.
At each documented waiting-list transition through 24 months after enrollment.
Initiation of Temporary Mechanical Circulatory or Extracorporeal Life Support
Временное ограничение: Through 24 months after enrollment.
Percentage of enrolled participants with initiation of protocol-defined temporary mechanical circulatory support or extracorporeal life support; organ supported, configuration, and therapeutic intent are classified.
Through 24 months after enrollment.
Durable Mechanical Support Implantation
Временное ограничение: Through 24 months after enrollment.
Percentage of enrolled participants receiving protocol-defined durable mechanical circulatory support; device category and therapeutic strategy are reported separately.
Through 24 months after enrollment.
Transplantation by Organ Type
Временное ограничение: Through 24 months after enrollment.
Percentage of enrolled participants who undergo heart or combined transplantation, reported separately by transplant type.
Through 24 months after enrollment.
Advanced Structural Heart Intervention
Временное ограничение: Through 24 months after enrollment.
Percentage of enrolled participants who undergo a protocol-defined advanced structural heart intervention as the documented destination therapy.
Through 24 months after enrollment.
Survival Free From Irreversible Clinical Deterioration
Временное ограничение: At 90 days, 1 year, and 2 years after enrollment.
Percentage of enrolled participants alive without protocol-defined irreversible deterioration that precludes the intended advanced-therapy pathway at each prespecified time point.
At 90 days, 1 year, and 2 years after enrollment.
Resolution of Identified Barriers
Временное ограничение: Within 180 days after identification of each barrier.
Percentage of prespecified clinical, administrative, financial, regulatory, logistical, geographic, social, technological, or information barriers documented as resolved according to the barrier-specific rule; each barrier is the unit of analysis.
Within 180 days after identification of each barrier.
Authorized Enrollment in an External Advanced-Therapy Protocol
Временное ограничение: Through 24 months after enrollment.
Percentage of enrolled participants who provide protocol-specific consent and are formally enrolled in an independently governed advanced-therapy protocol. Referral, contact, screening, or APD-G alone is not enrollment. This outcome measures access and not efficacy or safety of the external product.
Through 24 months after enrollment.
Utilization of TORCH-Evaluated Donor Organs
Временное ограничение: Up to 24 months after participant enrollment.
Percentage of donor organs meeting the prespecified evaluable-opportunity denominator that are implanted. Final disposition is classified as implanted, recovered but not implanted, or not recovered, with prespecified reasons for non-use recorded.
Up to 24 months after participant enrollment.

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

CardioVision International Tech, S.A.S. de C.V.

Соавторы

Advanced Sciences Technologies, S.A. de C.V.
Advanced Science Technologies S.A.S.

Следователи

  • Главный следователь: Eliecer Villamizar De La Hoz, MD, CardioVision International Tech S.A. de C.V.

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

30 марта 2027 г.

Первичное завершение (Оцененный)

30 марта 2029 г.

Завершение исследования (Оцененный)

30 марта 2031 г.

Даты регистрации исследования

Первый отправленный

8 сентября 2026 г.

Впервые представлено, что соответствует критериям контроля качества

11 сентября 2026 г.

Первый опубликованный (Действительный)

17 сентября 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

17 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

11 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Другие идентификационные номера исследования

  • TORCH-LATAM-004

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕ РЕШЕНО

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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