Angiography and Electrogram Guided Bachmann Bundle Pacing

Официальное название

Angiography and Electrogram Guided Bachmann Bundle Pacing - ANGEL BBP

Обзор

People eligible for this study are scheduled to have a permanent pacemaker (PPM) or defibrillator device (ICD) implanted as part of their routine care. This device will also have a wire placed in the right atrium (RA) of the heart. As an alternative to the RA, the wire can also be placed in the Bachmann bundle (BB). This study is being done to compare two options to help place the wire in the Bachmann bundle. One option uses contrast dye and x-ray, and the other option uses electrocardiogram (ECG) and contrast dye and x-ray. We want to learn more about how well these options work in implanting the wire in the Bachmann bundle. Both of these options are FDA approved and used in standard practice.

Подробное описание

The ANGEL BBP study is a prospective, single-center, randomized, controlled research study. The study team will identify all patients who satisfy the inclusion and exclusion criteria. The study team will evaluate the feasibility and success rates of Angiography guided Bachmann bundle pacing (BBP) lead implantation compared to traditional approach.

Eligible patients would undergo BBP using Medtronic 3830 lead and C304 or C315 family of sheaths. BBP will be confirmed at implant using Bachmann bundle potentials recorded from the lead, ECG 'P' wave morphology and duration during atrial pacing, fluoroscopic locations on right anterior oblique (RAO) and left anterior oblique (LAO) projections.

During implant procedure, 5-10 ml of contrast will be used to perform inferior superior vena cava (SVC) angiogram via the lead delivery sheath in RAO and LAO views. The pacing lead will be then implanted using these images as guidance along with recording of local electrograms from the pacing lead.

The study team will randomize 50 patients who satisfy inclusion and exclusion criteria. The study team will compare the difference in procedural success between Angiography and Electrogram guided BBP and Electrogram/ECG only guided BBP patients.

Вмешательства

• Диагностический тест Angiography only
  Superior vena cava (SVC) angiogram will be used to anatomically identify the BB region
• Диагностический тест Angiography and ECG
  Superior vena cava (SVC) angiogram will be used to anatomically identify the BB region and correlate with electrogram guidance for BBP

Первичные конечные точки

• Success of Bachmann bundle pacing using angiography at implant [Срок оценки: Perioperative]
• Change in implant procedure duration [Срок оценки: Perioperative]

Вторичные конечные точки (3)

• Atrial pacing parameters [Срок оценки: 3 month follow up]
• Paced P-wave morphology compared to native P-waves [Срок оценки: 3 month follow up]
• Paced P-wave duration compared to native P-waves [Срок оценки: 3 month follow up]

Критерии участия

Критерии включения

• Patients > 18 years of age
• Patient with an indication for permanent pacemaker or ICD utilizing atrial pacing lead
• Patient is willing to comply with all study procedures and be available for the duration of the study.

Критерии исключения

• Inability to provide informed consent
• Pregnant
• Enrolled in a concurrent study that may confound the results of this study.
• Persistent atrial fibrillation at the time of implant (if cardioversion contraindicated at the time of implant, where BB mapping cannot be performed in sinus rhythm)
• Renal dysfunction with serum Creatinine >3.0 mg/dl

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

США · 1 центр

• Geisinger Wyoming Valley — Wilkes-Barre

Идентификаторы

NCT: NCT07110922 · 2025-0403

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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