Actively Recruiting

Age: 18Years +
All Genders
ID07020910

Bad Berka Heart Rhythm Registry Evaluating Safety, Efficacy, and Outcomes in Patients Undergoing Arrhythmia Therapy or Cardiac Device Implantation at Heart Center Bad Berka

Led by Zentralklinik Bad Berka · Updated on 2025-06-13

5000

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are gathering real-world data in the Bad Berka Heart Rhythm Registry (2B2R), a prospective, single-center observational study focused on patients undergoing treatment for cardiac arrhythmias or implantation of cardiac electronic devices (CIEDs) at the Heart Center Bad Berka. This registry aims to evaluate procedural safety, short- and long-term effectiveness, and clinical outcomes across various arrhythmias and interventional methods, including new technologies like pulsed field ablation and conduction system pacing. The goal is to support clinical decisions, identify outcome predictors, and improve quality and innovation in cardiac electrophysiology. Patients included in the registry receive standard care for arrhythmias such as drug therapy, electrophysiological studies, catheter ablation for conditions like atrial fibrillation, atrial flutter, supraventricular tachycardias, premature ventricular contractions, and ventricular tachycardia, as well as stroke prevention interventions and device implantation. Data collection is prospective and covers procedural details, complication rates, acute success, follow-up results, imaging, device therapy, and patient-reported outcomes. The registry includes substudies focusing on specific arrhythmias or technologies. Participants provide informed consent and continue usual clinical management by their physicians. Researchers assess acute treatment success and safety within 30 days, as well as arrhythmia recurrence, rehospitalization, symptom and quality of life changes, and device therapy outcomes over about one year. The registry complies with ethical and data protection standards and does not alter clinical care. Participation involves data collection from treatment and follow-up without influencing the therapy itself.

CONDITIONS

Brief Title

Bad Berka Heart Rhythm Registry of Patients With or at Risk of Arrhythmias Treated at Heart Center Bad Berka

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • At risk of or diagnosed with cardiac arrhythmia undergoing medical or interventional therapy at the Heart Center Bad Berka
  • Provided informed consent to participate
Not Eligible

You will not qualify if you...

  • Unable or unwilling to provide informed consent
  • Currently participating in another interventional trial that excludes registry inclusion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 1 day

Participants undergo diagnostic assessments related to arrhythmia and cardiac device therapy as part of routine clinical care.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 1 year

Participants who undergo routine arrhythmia treatment and cardiac device implantation are observed to collect data on clinical effectiveness, safety, and patient outcomes.

Approximately 4 follow-up visits (in-person or remote) over 1 year

Trial Site Locations

Total: 1 location

1

Zentralklinik Bad Berka

Bad Berka, Germany

Actively Recruiting

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Research Team

C

Christoph Geller, Prof. Dr. med.

S

Santi Raffa, Dr. (Univ. Messina) Ph.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Feasibility and Clinical Efficacy of Focal Pulsed Field Ablation in Patients With Non-Pulmonary Vein Triggered Atrial Arrhythmia From the Superior Caval Vein.

Ahmad Keelani, Obaida Alothman, Georgi Borisov...

https://pubmed.ncbi.nlm.nih.gov/39654529