Cardiac Arrhythmias2B2RNCT07020910
Bad Berka Heart Rhythm Registry of Patients With or at Risk of Arrhythmias Treated at Heart Center Bad Berka
An observational study of Cardiac Arrhythmias, run by Zentralklinik Bad Berka at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrhythmias
- How many people
- 5,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2024to 1 Aug 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Inability or unwillingness to provide informed consent
- Participation in another interventional trial that precludes registry inclusion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Zentralklinik Bad Berka
Bad Berka
Christoph Geller, Prof. Dr. med., +49 (0) 36458 5-1201 / 1205, kar@zentralklinik.de
Santi Raffa, Dr. (Univ. Messina) Ph.D., +49 (0) 36458 5-1201 / 1205, kar@zentralklinik.de
About this study
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
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.
Read the 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.
- Conditions
- Cardiac Arrhythmias
- Keywords
- Arrhythmia
- Medical subject headings
- Arrhythmias, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Treatment Success
- 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)
Measured: 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)
Measured: within 30 days
Secondary outcomes (6)
Arrhythmia Recurrence
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…).
Measured: through study completion, an average of 1 year
All-cause Rehospitalization
Number of hospitalizations following the index procedure.
Measured: through study completion, an average of 1 year
Symptom and Quality of Life Improvement
Based on structured follow-up or telephone follow up where applicable.
Measured: through study completion, an average of 1 year
Device Therapy Outcomes (in patients with CIEDs)- 1.Lead performance -
evaluation of implanted cardiac device leads (pacemaker, ICD, CRT) in terms of electrical integrity, sensing and pacing thresholds, impedance stability.
Measured: through study completion, an average of 1 year
Device Therapy Outcomes (in patients with CIEDs) - 2. Appropriate and inappropriate therapies-
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.
Measured: through study completion, an average of 1 year
Device Therapy Outcomes (in patients with CIEDs)-3. Device related complications-
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start1 Aug 2024
- Primary completion1 Aug 2029 (estimated)
- Study completion1 Aug 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrhythmiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zentralklinik Bad Berka
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Santi Raffa, Zentralklinik Bad Berka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020910
- Sponsor's protocol ID
- # 23333/2024/62
- Acronym
- 2B2R
- Status last verified
- Sep 2026
- First submitted
- 22 May 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 39654529
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07020910
- Acronym / sponsor ID
- 2B2R / # 23333/2024/62
- Conditions
- Cardiac Arrhythmias
- Keywords
- Arrhythmia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Zentralklinik Bad BerkaUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Aug 2029 (estimated)
- Study completion
- 1 Aug 2034 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Inability or unwillingness to provide informed consent
- Participation in another interventional trial that precludes registry inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acute Treatment Success
Time frame: Perioperative/Periprocedural
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)
Safety (peri-procedural Complications)
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)
6 secondary outcomes
Arrhythmia Recurrence
Time frame: through study completion, an average of 1 year
All-cause Rehospitalization
Time frame: through study completion, an average of 1 year
Symptom and Quality of Life Improvement
Time frame: through study completion, an average of 1 year
Device Therapy Outcomes (in patients with CIEDs)- 1.Lead performance -
Time frame: through study completion, an average of 1 year
Device Therapy Outcomes (in patients with CIEDs) - 2. Appropriate and inappropriate therapies-
Time frame: through study completion, an average of 1 year
Device Therapy Outcomes (in patients with CIEDs)-3. Device related complications-
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Results publication: PubMed 39654529Keelani 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrhythmias, run by Zentralklinik Bad Berka at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christoph Geller, Prof. Dr. med. (+49 (0) 36458 5-1201 / 1205, kar@zentralklinik.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Treatment Success (time frame: Perioperative/Periprocedural). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07020910, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.