Bad Berka Heart Rhythm Registry of Patients With or at Risk of Arrhythmias Treated at Heart Center Bad Berka (2B2R)

Zentralklinik Bad Berka

Status: Enrolling

Conditions: Cardiac Arrhythmias

Study type: Observational

Funder types: Other

Identifiers

NCT07020910

# 23333/2024/62

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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