NCT Number: NCT07020910
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Bad Berka, Germany
Location status: Recruiting
Christoph Geller, Prof. Dr. med.
CONTACT
+49 (0) 36458 5-1201 / 1205
J. Christoph Geller, Prof. Dr. med.
PRINCIPAL_INVESTIGATOR
Santi Raffa, Dr. (Univ. Messina) Ph.D
PRINCIPAL_INVESTIGATOR
Santi Raffa, Dr. (Univ. Messina) Ph.D.
CONTACT
+49 (0) 36458 5-1201 / 1205
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
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Perioperative/Periprocedural
Time frame: 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)
Time frame: through study completion, an average of 1 year
Documented recurrence of the treated arrhythmia after the blanking period (if applicable), using scheduled 24-48h Holter-ECG, 12-lead-ECG, CIEDs, and smart devices (e.g. smart-watch…).
Time frame: through study completion, an average of 1 year
Number of hospitalizations following the index procedure.
Time frame: through study completion, an average of 1 year
Based on structured follow-up or telephone follow up where applicable.
Time frame: through study completion, an average of 1 year
evaluation of implanted cardiac device leads (pacemaker, ICD, CRT) in terms of electrical integrity, sensing and pacing thresholds, impedance stability.
Time frame: through study completion, an average of 1 year
Number and type of appropriate and inappropriate device therapies (e.g., anti-tachycardia pacing or shocks) delivered by implantable cardioverter-defibrillators (ICDs) or CRT-Ds.
Time frame: through study completion, an average of 1 year
Incidence of device-related complications following implantation of cardiac implantable electronic devices (CIEDs), including lead dislodgement, infection, hematoma requiring intervention, pneumothorax, lead fracture, insulation failure, and pocket erosion.
Contact information is provided by the study sponsor or research team.
Christoph Geller, Prof. Dr. med.
CONTACT
+49 (0) 36458 5-1201 / 1205
Santi Raffa, Dr. (Univ. Messina) Ph.D.
CONTACT
+49 (0) 36458 5-1201 / 1205
Zentralklinik Bad Berka
Other
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
Acronym: 2B2R
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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