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临床试验/NCT07020910
NCT07020910招募中不适用

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

Zentralklinik Bad Berka1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2024年8月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
5,000
试验地点
1
主要终点
Safety (peri-procedural Complications)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Inability or unwillingness to provide informed consent
  • Participation in another interventional trial that precludes registry inclusion

结局指标

主要结局

Safety (peri-procedural Complications)

时间窗: within 30 days

Incidence of major complications (e.g. development of ventricular proarrhythmia, tamponade, stroke, vascular injury, AV-block, phrenic nerve palsy, pneumothorax, hemothorax, lead dislodgment, or death)

Acute Treatment Success

时间窗: Perioperative/Periprocedural

1\. Acute Treatment Success Defined as acute symptom control and achievement of predefined procedural endpoints (e.g. AV-nodal modification, elimination of accessory pathway conduction, pulmonary vein isolation, bidirectional block across linear ablation lesions, suppression of ectopic beats, non-inducibility of the clinical arrhythmia, effective occlusion of the left atrial appendage, successful CIED-implantation)

次要结局

  • All-cause Rehospitalization(through study completion, an average of 1 year)
  • Symptom and Quality of Life Improvement(through study completion, an average of 1 year)
  • Device Therapy Outcomes (in patients with CIEDs)- 1.Lead performance -(through study completion, an average of 1 year)
  • Device Therapy Outcomes (in patients with CIEDs) - 2. Appropriate and inappropriate therapies-(through study completion, an average of 1 year)
  • Device Therapy Outcomes (in patients with CIEDs)-3. Device related complications-(through study completion, an average of 1 year)
  • Arrhythmia Recurrence(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Santi Raffa

Dr. PhD.

Zentralklinik Bad Berka

研究点 (1)

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