Convergent Ablation Plus Left Atrial Appendage Isolation for the Treatment of Persistent Atrial Fibrillation

Обзор

A randomised controlled clinical trial to assess efficacy of convergent ablation with the LARIAT procedure, as compared to standard endocardial catheter ablation in patients with long-standing persistent atrial fibrillation (AF).

Подробное описание

Atrial Fibrillation is the commonest arrhythmia and is a major cause of morbidity and mortality, often causative in ischaemic strokes and compounded by heart failure. Treatment options are limited for persistent long-standing AF (PeAF), with pulmonary vein isolation by endocardial ablation being insufficient and further additive endocardial lesions with repeated ablations yield mixed results resultant in further atrial arrhythmias. Currently success rates for catheter ablation are moderate at 40 to 70% in a single procedure.

If this was improved, patient quality of life and readmission rates would significantly improve as well as a reduction in anti-arrhythmic drug use.

The Convergent procedure - is a two stage minimally invasive hybrid approach. The first stage employs surgical ablation to the posterior wall of the left atrium in combination with the LARIAT procedure to isolate the left atrium appendage (LAA). The second stage involves endocardial catheter ablation to confirm the surgical ablation lesions, and perform further endocardial catheter ablation to leverage both epicardial and endocardial lesions to create durable, transmural lesions.

Patients with long-standing persistent AF will be randomised in a 1:1 ratio to either the Convergent ablation with the LARIAT procedure or the standard endocardial catheter ablation.

This feasibility study would assess recruitment to the trial, safety and efficacy of the Convergent procedure, in combination with a left atrial appendage system.

Вмешательства

• Устройство Epicardial AF ablation using AtriCure EPi-Sense-AF Guided Coagulation System with Left Atrial Appendage Exclusion using the AtriCure LARIAT Suture Delivery Device.
  2 stage procedure - minimally-invasive epicardial ablation with left atrial appendage exclusion using LARIAT procedure via a subxiphoid incision. This is then combined with endocardial radiofrequency catheter ablation in a separate staged procedure.
• Процедура Standard Endocardial Catheter Ablation
  Standard percutaneous endocardial catheter ablation of atrial fibrillation

Первичные конечные точки

• Demonstrate trial feasibility with regards to recruitment rate [Срок оценки: 24 months]
• A composite of major adverse events (MAE) and complications occurring within 30 days post procedure will be measured. [Срок оценки: 30 days post procedure]
• Success or failure at 12 months of persistent AF patients to be free of: Atrial arrhythmia (classed as documentation of atrial fibrillation, atrial flutter or atrial tachycardia lasting for more than 30 seconds) [Срок оценки: Measured from the end of a 3 month blanking period to 12 months post procedure]
• Measure improvement in symptoms following convergent ablation [Срок оценки: 12 months]

Вторичные конечные точки (3)

• Measure improvement in symptoms following convergent ablation. [Срок оценки: 12 months]
• Changes in baseline left ventricular ejection fraction (LVEF) in patients with severe left ventricular systolic dysfunction (EF <35%) will be measured. [Срок оценки: 12 months]
• Measure improvement in NYHA (New York Heart Association) class in patients with NYHA class III to IV following convergent AF ablation. [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Age > 18 years; < 80 years
• Persistent AF > 1-year duration
• Left atrium size < 6cm
• Pts should be able to provide written informed consent.

Критерии исключения

• Subjects currently enrolled in another investigational study except in case of observational registry with no associated treatments.
• Subject has a reversible cause of AF or transient AF
• Subject is absent of LAA or if the LAA is previously surgically ligated
• Subject has had previous cardiac surgery or abdominal surgery.
• Subject has contraindication to anticoagulation.
• Patients with hypertrophic cardiomyopathy.
• Patients with significant valve disease.
• Subject has had previous catheter or surgical ablation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Великобритания · 1 центр

• St Bartholomew's Hospital — London

Идентификаторы

NCT: NCT06165510 · 320553

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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