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/39654529Actively Recruiting
Led by Zentralklinik Bad Berka · Updated on 2025-06-13
5000
Participants Needed
1
Research Sites
260 weeks
Total Duration
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
Bad Berka Heart Rhythm Registry of Patients With or at Risk of Arrhythmias Treated at Heart Center Bad Berka
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
Total: 1 location
1
Zentralklinik Bad Berka
Bad Berka, Germany
Actively Recruiting
C
Christoph Geller, Prof. Dr. med.
S
Santi Raffa, Dr. (Univ. Messina) Ph.D.
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Ahmad Keelani, Obaida Alothman, Georgi Borisov...
https://pubmed.ncbi.nlm.nih.gov/39654529