Esophageal Temperature During PVI Using Q-DOT Micro

Официальное название

Esophageal Temperature Dynamics and Injury During Pulmonary Vein Isolation With Temperature Controlled Very-High-Power Short-Duration Lesions Using the Novel Q-DOT Micro Ablation Catheter

Обзор

This study will assess how two different ablation strategies, using two different ablation catheters during catheter ablation for paroxysmal atrial fibrillation, affect the temperature of the esophagus during ablation, and the risk of injury to the esophagus.

Подробное описание

This is a prospective randomized controlled trial, studying patients undergoing ablation involving pulmonary vein isolation for paroxysmal atrial fibrillation. Patients will be assigned to undergo conventional high-power short-duration ablation or temperature-controlled very-high-power short-duration ablation, and esophageal outcomes including temperature changes during ablation and esophageal injury as assessed by post-procedure capsule endoscopy will be compared between the groups. The hypothesis is that very-high-power short-duration ablation will lead to lower rises in esophageal temperature and lower rates of esophageal findings during capsule endoscopy.

Вмешательства

• Устройство QDOT Micro ablation catheter
  QDOT Micro ablation catheter
• Устройство ST SF ablation catheter
  ST SF ablation catheter

Первичные конечные точки

• Maximal change in esophageal temperature during posterior wall isolation. [Срок оценки: During ablation procedure.]

Вторичные конечные точки (2)

• Presence of esophageal thermal injury seen on post-procedure capsule endoscopy. [Срок оценки: 2-4 days after ablation procedure.]
• Presence of procedural complications. [Срок оценки: During and immediately following ablation procedure.]

Критерии участия

Критерии включения

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged greater than or equal to 18 years
• Diagnosed with paroxysmal atrial fibrillation
• Undergoing RF catheter ablation for treatment of paroxysmal atrial fibrillation that will involve circumferential point-by-point radiofrequency ablation pulmonary vein isolation with no additional left atrial posterior wall ablation planned

Критерии исключения

• Patients who have undergone prior left atrial ablation procedures.
• Patients where the use of the Q-DOT Micro ablation catheter in QMODE+ (i.e. temperature-controlled very-high-power short-duration ablation) is felt to be unsafe.
• Patients who have contraindications to capsule endoscopy, or GI conditions that may increase the risks of capsule endoscopy (e.g. esophageal strictures, inflammatory bowel disease, etc)
• Any records flagged "break the glass" or "research opt out."

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

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Cedars-Sinai Smidt Heart Institute — Los Angeles

Идентификаторы

NCT: NCT06392932 · STUDY00002707

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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