Long Term Evaluation and Management of Atrial Fibrillation in Pacemaker Patients

Официальное название

Long Term Evaluation and Management of Atrial Fibrillation in Pacemaker Patients (AF-pacemaker Tx Study)

Обзор

This study is prospective randomized study which was performed in multicenter (General Hospital) in Korea. Inclusion criteria is patients who developed atrial fibrillation/flutter/tachycardia after pacemaker implantation among AF-pacemaker study (ClinicalTrials.gov Identifier: NCT03303872). The purpose is to investigate the recurrence rate of AF/AFL/AT in both groups after randomization for 60 months (5 years) in patients post pacemaker implantation and assess long term clinical results.

Вмешательства

• Препарат midazolam with fentanyl
  Radio-frequency catheter ablation is performed in the post-absorptive state after sedation with midazolam and fentanyl. Multipolar catheters were positioned in the coronary sinus, His, and the right atrium. The three-dimensional LA geometry was reconstructed using a CARTO or NavX electroanatomical mapping system. Circumferential pulmonary vein isolation was performed in all patients using a irrigated-tip catheter. A circular mapping catheter was used to confirm the isolation of the pulmonary vei

Первичные конечные точки

• Recurrence rate of AF/AFL/AT in both groups [Срок оценки: 1 year after randomization]
• Recurrence rate of AF/AFL/AT in both groups [Срок оценки: 6-month follow up to 5 years]

Вторичные конечные точки (4)

• Left ventricular ejection fraction [Срок оценки: 1 year after randomization]
• Left atrial diameter [Срок оценки: 1 year after randomization]
• Stroke [Срок оценки: at least 1 year after randomization]
• Stroke [Срок оценки: 6-month follow up to 5 years]

Критерии участия

Критерии включения

• Patients who developed atrial fibrillation/flutter/tachycardia after pacemaker implantation among AF-pacemaker study (ClinicalTrials.gov Identifier: NCT03303872).
• Age: 18-80 years
• Patients eligible for the indications for permanent pacemaker implantation in accordance with 2016 revised Korean indication guideline on cardiac pacemaker implantation
• Estimated percentage of atrial pacing >40% under sinus rhythm (LR≥60bpm, close hysteresis and rest rate)
• Estimated percentage of ventricular pacing >40% under sinus rhythm (LR≥40bpm, DDD pacing, close hysteresis and rest rate)
• Patients who are willing to sign the informed consent.
• Patients who are willing to receive the implantation and post-operative follow-up.

Критерии исключения

• Persistent or permanent AF
• Severe hepatic and renal insufficiency (AST or ALT ≥ three times of normal upper limit; SCr > 3.5 mg/dl or Ccr < 30ml/min)
• Thyroid gland dysfunction
• Pregnancy
• Malignant tumor
• Severe organic heart disease (such as moderate to severe mitral regurgitation, severe valvular regurgitation and stenosis, dilated cardiomyopathy, hypertrophic cardiomyopathy, severe heart valve disease)
• Life expectancy < 12 months
• Patients unable or unwilling to cooperate in the study procedures.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Division of Cardiology, Yonsei University Health System, Yonsei University College of Medi — Seoul

Идентификаторы

NCT: NCT03401593 · 4-2017-1028

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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