Набор по приглашению NCT07100483

Comparing Surgical Management Methods of Atrial Fibrillation

Без фазы С лечением Atrial Fibrillation

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: Atrial Fibrillation Ablation.
Кому может быть актуально: Состояния в реестре: Atrial Fibrillation. Базовые параметры: 18 лет — 85 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: США
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

Prospective, Randomized Trial Comparing Left Atrial Cox-Maze IV, Tampa 2 or Encompass Alone, Ablation in the Surgical Management of Atrial Fibrillation

Обзор

Compare the efficacy of the left atrial Cox-Maze IV lesion set versus the Tampa 2 lesion set versus the EnCompass ablation alone, in the surgical treatment of atrial fibrillation at one year post-operatively.

Подробное описание

This is a single center prospective, randomized trial to compare the outcomes, specifically the freedom from atrial fibrillation at one year, and possibly up to five years, of three different approaches to the cardiac surgical management of atrial fibrillation.

Several strategies to accomplish surgical ablation are acceptable and have been shown retrospectively to be successful. The Cox-Maze bi-atrial, left and right atrial lesions, ablation (whether III or IV) remains the gold standard by which all surgical ablations are compared. Further refinement in ablation technology and research has further suggested there is no difference between a left atrial ablation alone or bi-atrial ablation lesion set. For left atrial ablation alone, existent therapeutic options, which all meet equivalent standard of care, include a left atrial Cox-Maze IV , a Tampa 2 lesion set or utilizing a "box lesion" alone. Currently, there are no randomized, clinical trials demonstrating better efficacy (freedom from atrial fibrillation post-operatively) of one ablation strategy over another in patients undergoing cardiac surgery.

The rationale for the study is to demonstrate whether one ablation technique is more efficacious in the surgical treatment of AF. Should one technique prove superior it may clarify the question of which ablation strategy to utilize and encourage surgeons to implement a consistent approach to surgical ablation.

To our knowledge this study would be the first prospective, randomized trial in the United States comparing surgical lesion sets in the concomitant management of atrial fibrillation.

Вмешательства

Процедура Atrial Fibrillation Ablation
Ablation of the heart to reduce Afib Occurrence

Первичные конечные точки

Freedom from Atrial Fibrillation [Срок оценки: 30 days and 1 year]

Вторичные конечные точки (1)

Prescribed Antiarrhythmic and anticoagulant drugs [Срок оценки: 7 days and 1 year]

Критерии участия

Критерии включения

Adult patients with a history of preoperative atrial fibrillation, either paroxysmal or persistent, requiring concomitant surgical ablation who are scheduled to undergo cardiac surgical procedure(s) to be performed on cardiopulmonary bypass
Utilizing sternotomy approach requiring cardiopulmonary bypass
Male or Female subjects between age 18 to 85 years of age