Clinical trial NCT07020910: Bad Berka Heart Rhythm Registry of Patients With or at Risk of Arrhythmias Treated at Heart Center Bad Berka
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Arrhythmias
Keywords: Arrhythmia
Lead sponsor: Zentralklinik Bad Berka
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Cardiac Arrhythmias or at Risk for the Development of Cardiac Arrhythmias Undergoing Drug-Therapy or Interventional Procedures at the Heart Center Bad Berka

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Acute Treatment Success
timeFrame: Perioperative/Periprocedural
measure: Safety (peri-procedural Complications)
timeFrame: within 30 days
Secondary outcomes:
measure: Arrhythmia Recurrence
timeFrame: through study completion, an average of 1 year
measure: All-cause Rehospitalization
timeFrame: through study completion, an average of 1 year
measure: Symptom and Quality of Life Improvement
timeFrame: through study completion, an average of 1 year
measure: Device Therapy Outcomes (in patients with CIEDs)- 1.Lead performance -
timeFrame: through study completion, an average of 1 year
measure: Device Therapy Outcomes (in patients with CIEDs) - 2. Appropriate and inappropriate therapies-
timeFrame: through study completion, an average of 1 year
measure: Device Therapy Outcomes (in patients with CIEDs)-3. Device related complications-
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka
Study officials:
References:
citation: Keelani A, Alothman O, Borisov G, Frommhold M, Bartoli L, Abdelwahab H, D'Ambrosio G, Shehri SA, Raffa S, Geller JC. Feasibility and Clinical Efficacy of Focal Pulsed Field Ablation in Patients With Non-Pulmonary Vein Triggered Atrial Arrhythmia From the Superior Caval Vein. J Cardiovasc Electrophysiol. 2025 Feb;36(2):359-366. doi: 10.1111/jce.16510. Epub 2024 Dec 10.