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

NCT07020910 | Recruiting

• 1 other identifier: # 23333/2024/62
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrhythmias

Keywords

Arrhythmia

Outcome Measures

Primary Outcomes (2)

• Acute Treatment Success

  1\. Acute Treatment Success Defined as acute symptom control and achievement of predefined procedural endpoints (e.g. AV-nodal modification, elimination of accessory pathway conduction, pulmonary vein isolation, bidirectional block across linear ablation lesions, suppression of ectopic beats, non-inducibility of the clinical arrhythmia, effective occlusion of the left atrial appendage, successful CIED-implantation)

  Perioperative/Periprocedural

• Safety (peri-procedural Complications)

  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)

  within 30 days

Secondary Outcomes (6)

• Arrhythmia Recurrence

  through study completion, an average of 1 year

• All-cause Rehospitalization

  through study completion, an average of 1 year

• Symptom and Quality of Life Improvement

  through study completion, an average of 1 year

• Device Therapy Outcomes (in patients with CIEDs)- 1.Lead performance -

  through study completion, an average of 1 year

• Device Therapy Outcomes (in patients with CIEDs) - 2. Appropriate and inappropriate therapies-

  through study completion, an average of 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Inability or unwillingness to provide informed consent

Sponsors & Collaborators

• Zentralklinik Bad Berka: lead

Study Sites (1)

Zentralklinik Bad Berka

Bad Berka, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 39654529 RESULT

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Christoph Geller, Prof. Dr. med.

CONTACT

+49 (0) 36458 5-1201 / 1205; kar@zentralklinik.de

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

CONTACT

+49 (0) 36458 5-1201 / 1205; kar@zentralklinik.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. PhD.

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: June 13, 2025
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2034
• Last Updated: June 13, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

DE (1)