Bad Berka Heart Rhythm Registry of Patients With or at Risk of Arrhythmias Treated at Heart Center Bad Berka
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Cardiac Arrhythmias. Базовые параметры: от 18 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
- Германия
- 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
The Bad Berka Heart Rhythm Registry (2B2R) is a Prospective, Single-center Observational Cohort Evaluating Safety, Efficacy, and Outcomes in Patients Undergoing Arrhythmia Therapy or CIED Implantation at the Heart Center Bad Berka
Обзор
The Bad Berka Heart Rhythm Registry (2B2R) is a prospective, single-center observational cohort designed to systematically collect and analyze data of patients undergoing cardiac arrhythmia therapy as well as implantation of cardiac electronic devices (CIEDs) at the Heart Center Bad Berka. The register aims to evaluate procedural safety, acute and long-term efficacy, and clinical outcomes across a broad spectrum of arrhythmias and interventional strategies, including novel technologies such as pulsed field ablation (PFA) and conduction system pacing. The registry is intended to generate real-world evidence to support clinical decision-making, identify predictors of outcomes, and contribute to quality assurance and innovation in the field of cardiac electrophysiology.
Подробное описание
The field of cardiac electrophysiology continues to evolve rapidly, with new tools and techniques improving both arrhythmia diagnosis and therapy. While randomized controlled trials provide critical insights, real-world data from clinical practice are essential to evaluate safety, efficacy, and long-term outcomes across diverse patient populations and treatment modalities.
The 2B2R registry aims to bridge this gap by collecting comprehensive clinical data of patients referred for cardiac arrhythmia treatment including drug therapy, electrophysiological studies, catheter ablation (e.g. atrial fibrillation, atrial flutter, atrial and AV-node dependent supraventricular tachycardia, premature ventricular contractions, and ventricular tachycardia), interventional stroke-prevention, as well as device implantation at the Heart Center Bad Berka.
Data will be prospectively collected, procedural parameters, complication rates, acute success, follow-up outcomes, imaging, device therapy, and patient-reported outcomes will be assessed. Substudies focused on specific arrhythmias or technologies (e.g., pulsed field ablation, high-density mapping, or device therapy such as conduction system pacing) will be embedded within the registry.
The data will be analyzed to: - Evaluate clinical effectiveness and safety of interventional EP procedures - Assess predictors of arrhythmia recurrence or procedural complications - Compare technologies and procedural strategies
\- Monitor quality metrics and inform continuous process improvement Participation in the registry does not influence clinical management which remains at the discretion of the treating physicians. The registry complies with all applicable data protection and ethical standards.
Первичные конечные точки
- Acute Treatment Success [Срок оценки: Perioperative/Periprocedural]
- Safety (peri-procedural Complications) [Срок оценки: within 30 days]
Вторичные конечные точки (6)
- Arrhythmia Recurrence [Срок оценки: through study completion, an average of 1 year]
- All-cause Rehospitalization [Срок оценки: through study completion, an average of 1 year]
- Symptom and Quality of Life Improvement [Срок оценки: through study completion, an average of 1 year]
- Device Therapy Outcomes (in patients with CIEDs)- 1.Lead performance - [Срок оценки: through study completion, an average of 1 year]
- Device Therapy Outcomes (in patients with CIEDs) - 2. Appropriate and inappropriate therapies- [Срок оценки: through study completion, an average of 1 year]
- Device Therapy Outcomes (in patients with CIEDs)-3. Device related complications- [Срок оценки: through study completion, an average of 1 year]
Критерии участия
Критерии включения
- Age ≥18 years
- At risk of or with documented cardiac arrhythmia undergoing medical or interventional therapy at the Heart Center Bad Berka
- Informed consent obtained
Критерии исключения
- Inability or unwillingness to provide informed consent
- Participation in another interventional trial that precludes registry inclusion
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Германия · 1 центр
- Zentralklinik Bad Berka — Bad Berka
Публикации
- Keelani A, Alothman O, Borisov G, Frommhold M, Bartoli L, Abdelwahab H, D'Ambrosio G, Shehri SA, Raffa S, Geller JC. Feasibility and Clinical Efficacy of Focal Pulsed Field Ablation in Patients With Non-Pulmonary Vein Triggered Atrial Arrhythmia From the Superior Caval Vein. J Cardiovasc Electrophysiol. 2025 Feb;36(2):359-366. doi: 10.1111/jce.16510. Epub 2024 Dec 10. PMID 39654529
Идентификаторы
NCT: NCT07020910 · # 23333/2024/62