TORCH-LATAM-004: Regional Advanced-Therapy Pathways for Adults With Acquired or Structural Heart Disease (TORCH-004)
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
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Eliecer Villamizar De La Hoz, MD
- 電話番号：+50370878226
- メール：eliecerevillamizar@gmail.com
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：順次割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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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.
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介入なし：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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Completion of Multidisciplinary Adult Advanced-Therapy Evaluation and Documented Pathway Decision Within 90 Days
時間枠：Within 90 days after enrollment.
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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.
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Within 90 days after enrollment.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Activation of an Authorized Advanced-Therapy Pathway or Official Waiting List
時間枠：Within 180 days after the first documented advanced-pathway decision qualifying for activation.
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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.
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Within 180 days after the first documented advanced-pathway decision qualifying for activation.
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Time to Completed Multidisciplinary Evaluation and Advanced-Pathway Decision
時間枠：From enrollment to completed evaluation and documented advanced-pathway decision, assessed through 180 days.
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Time from enrollment to completion of the prespecified multidisciplinary adult evaluation and documentation of a valid advanced-pathway decision.
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From enrollment to completed evaluation and documented advanced-pathway decision, assessed through 180 days.
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Redirection of the Advanced-Therapy Pathway
時間枠：Through 24 months after enrollment.
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Percentage of enrolled participants with a documented change in intended advanced therapy or destination pathway, with origin, destination, authority, and reason recorded.
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Through 24 months after enrollment.
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Waiting-List Status or Urgency Transition
時間枠：At each documented waiting-list transition through 24 months after enrollment.
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Number and distribution of documented waiting-list status or urgency transitions by reason among participants with an official waiting-list episode.
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At each documented waiting-list transition through 24 months after enrollment.
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Initiation of Temporary Mechanical Circulatory or Extracorporeal Life Support
時間枠：Through 24 months after enrollment.
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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.
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Through 24 months after enrollment.
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Durable Mechanical Support Implantation
時間枠：Through 24 months after enrollment.
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Percentage of enrolled participants receiving protocol-defined durable mechanical circulatory support; device category and therapeutic strategy are reported separately.
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Through 24 months after enrollment.
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Transplantation by Organ Type
時間枠：Through 24 months after enrollment.
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Percentage of enrolled participants who undergo heart or combined transplantation, reported separately by transplant type.
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Through 24 months after enrollment.
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Advanced Structural Heart Intervention
時間枠：Through 24 months after enrollment.
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Percentage of enrolled participants who undergo a protocol-defined advanced structural heart intervention as the documented destination therapy.
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Through 24 months after enrollment.
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Survival Free From Irreversible Clinical Deterioration
時間枠：At 90 days, 1 year, and 2 years after enrollment.
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Percentage of enrolled participants alive without protocol-defined irreversible deterioration that precludes the intended advanced-therapy pathway at each prespecified time point.
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At 90 days, 1 year, and 2 years after enrollment.
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Resolution of Identified Barriers
時間枠：Within 180 days after identification of each barrier.
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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.
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Within 180 days after identification of each barrier.
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Authorized Enrollment in an External Advanced-Therapy Protocol
時間枠：Through 24 months after enrollment.
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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.
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Through 24 months after enrollment.
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Utilization of TORCH-Evaluated Donor Organs
時間枠：Up to 24 months after participant enrollment.
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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.
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Up to 24 months after participant enrollment.
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協力者と研究者
捜査官
- 主任研究者：Eliecer Villamizar De La Hoz, MD、CardioVision International Tech S.A. de C.V.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- TORCH-LATAM-004
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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