Premature Ventricular Contraction (PVC)NCT07003412
PULSE PVC Registry: Multicenter Study on Focal Pulsed Field Ablation for Premature Ventricular Contractions
An observational study of Premature Ventricular Contraction (PVC) and Pulsed Field Ablation, run by Zentralklinik Bad Berka at 1 site in Germany.
Trial summary
The PULSE PVC Registry is a European multicenter observational study designed to assess the safety and efficacy of focal pulsed field ablation (PFA) using the Centauri Generator system in patients with symptomatic premature ventricular contractions (PVCs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Premature Ventricular Contraction (PVC), Pulsed Field Ablation
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2024to 1 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: he study population consists of adult patients (age ≥18 years) with symptomatic premature ventricular contractions undergoing focal monopolar biphasic pulsed field ablation. All patients included must have been treated with the Centauri Generator system and have a minimum of 3 months of follow-up data available at the time of registry entry. The population is expected to be heterogeneous, including patients with and without structural heart disease, and PVCs originating from various anatomical sites. Patients will be enrolled across multiple European electrophysiology centers with varying procedural practices, enhancing the generalizability of the findings.
Who may be able to join
- Patients with symptomatic PVCs who underwent focal monopolar biphasic PFA
- Use of Centauri Generator system
- Minimum 3-month clinical follow-up at time of data entry
Who cannot join
- Incomplete procedural or follow-up data
- Patients receiving exclusively RF ablation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The PULSE PVC Registry Evaluates the Safety and Efficacy of Focal PFA Using the Centauri System for Symptomatic PVCs Across European Centers, With Outcomes Stratified by Site of Origin and Compared to Historical RF Ablation Data.
The PULSE PVC Registry is a European multicenter observational study designed to assess the safety and efficacy of focal pulsed field ablation (PFA) using the Centauri Generator system in patients with symptomatic premature ventricular contractions (PVCs). The registry collects standardized procedural and follow-up data across diverse PVC origins, enabling comparisons with historical radiofrequency (RF) ablation outcomes. Data will include baseline characteristics, procedural details, complications, and long-term PVC burden reduction. Each center will obtain local ethics approval, and only anonymized data will be analyzed.
Read the detailed description
The PULSE PVC Registry is a European multicenter observational registry designed to evaluate the safety, feasibility, and midterm outcomes of focal pulsed field ablation (PFA) for the treatment of symptomatic premature ventricular contractions (PVCs). The study includes patients undergoing focal PFA using a monopolar biphasic energy system (Centauri Generator), across multiple high-volume electrophysiology centers in Europe.
The registry collects detailed baseline demographics, comorbidities (e.g., hypertension, diabetes, chronic kidney disease), structural heart disease status, antiarrhythmic drug use, prior ablation history, and baseline PVC burden. Procedural characteristics include PVC mapping approach, pharmacologic testing (e.g., isoproterenol, nitroglycerin), number and type of ablation applications (PFA and/or RF), use of coronary angiography, venous system access (GCV/AIV), and fluoroscopy metrics.
Outcomes assessed include:
Primary outcome: Midterm clinical success, defined as a reduction in PVC burden to <5% on follow-up (via Holter monitoring)
Secondary outcomes: Acute procedural success, complication rates (e.g., coronary vasospasm, conduction disturbances, stroke, vascular complications), and recurrence patterns.
Patients are stratified based on the site of origin of PVCs (e.g., RVOT subregions, LVOT, aortic cusps, papillary muscles).
Follow-up includes symptom assessment, PVC burden, antiarrhythmic drug use, and mode of follow-up (telephone or in-person). The registry provides a comprehensive overview of clinical outcomes with focal PFA and enables comparison with historical radiofrequency ablation data.
This registry aims to generate robust real-world evidence to inform procedural strategy, patient selection, and safety considerations in PVC ablation using pulsed field energy.
- Medical subject headings
- Ventricular Premature Complexes
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from clinically significant PVCs at 6-month follow-up
Clinically significant PVCs are defined as a PVC burden ≥5% on 24-hour Holter ECG. The primary efficacy endpoint is the proportion of patients who achieve a reduction in PVC burden to <5% at 6 months following pulsed field ablation (PFA). PVC burden will be quantified using standardized 24-hour Holter recordings. Patients must not be on any new antiarrhythmic medication during this period to be considered a true efficacy responder.
Measured: through study completion, an average of 6 months
Secondary outcomes (2)
Acute Procedural Success
Acute procedural success is defined as complete elimination of the targeted PVC morphology by the end of the ablation procedure, confirmed by the absence of spontaneous or inducible PVCs following programmed stimulation and/or isoproterenol challenge.
Early PVC burden reduction is assessed via telemetry and 24-hour Holter monitoring performed during hospitalization. ≥80% reduction in PVC burden during the first 48 hours post-ablation is considered an early indicator of treatment efficacy.
Measured: Day 0 to Day 2 (during hospital stay)
Periprocedural Complication Rate
Procedure-related complications occurring during the hospital stay will be systematically recorded from the end of the procedure until discharge (typically Day 0 to Day 2). These include vascular complications (e.g., access-site hematoma, iliac artery dissection), conduction disturbances (e.g., transient or persistent right bundle branch block), coronary vasospasm, and cerebrovascular events.
Measured: Day 0 to Day 2 (hospital stay)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start1 Jun 2024
- Primary completion6 Jun 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ventricular Contraction (PVC)Studies 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
- Other
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zentralklinik Bad Berka
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Keelani, Zentralklinik Bad Berka
- Investigators
- J. Christoph Geller, Prof. Dr., Study director, Zentralklinikum Bad berkaSanti Raffa, Dr., Study director, Zentralklinik Bad Berka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003412
- Sponsor's protocol ID
- 23333/2024/62
- Status last verified
- Sep 2026
- First submitted
- 18 May 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision regarding IPD sharing is currently under review and will depend on institutional policies, ethical approvals.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PULSE PVC Registry Evaluates the Safety and Efficacy of Focal PFA Using the Centauri System for Symptomatic PVCs Across European Centers, With Outcomes Stratified by Site of Origin and Compared to Historical RF Ablation Data.
- ClinicalTrials.gov ID
- NCT07003412
- Acronym / sponsor ID
- 23333/2024/62
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Zentralklinik Bad BerkaUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 6 Jun 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 4 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 PULSE PVC Registry is a European multicenter observational study designed to assess the safety and efficacy of focal pulsed field ablation (PFA) using the Centauri Generator system in patients with symptomatic premature ventricular contractions (PVCs). The registry collects standardized procedural and follow-up data across diverse PVC origins, enabling comparisons with historical radiofrequency (RF) ablation outcomes. Data will include baseline characteristics, procedural details, complications, and long-term PVC burden reduction. Each center will obtain local ethics approval, and only anonymized data will be analyzed.
Detailed description
The PULSE PVC Registry is a European multicenter observational registry designed to evaluate the safety, feasibility, and midterm outcomes of focal pulsed field ablation (PFA) for the treatment of symptomatic premature ventricular contractions (PVCs). The study includes patients undergoing focal PFA using a monopolar biphasic energy system (Centauri Generator), across multiple high-volume electrophysiology centers in Europe.
The registry collects detailed baseline demographics, comorbidities (e.g., hypertension, diabetes, chronic kidney disease), structural heart disease status, antiarrhythmic drug use, prior ablation history, and baseline PVC burden. Procedural characteristics include PVC mapping approach, pharmacologic testing (e.g., isoproterenol, nitroglycerin), number and type of ablation applications (PFA and/or RF), use of coronary angiography, venous system access (GCV/AIV), and fluoroscopy metrics.
Outcomes assessed include:
Primary outcome: Midterm clinical success, defined as a reduction in PVC burden to <5% on follow-up (via Holter monitoring)
Secondary outcomes: Acute procedural success, complication rates (e.g., coronary vasospasm, conduction disturbances, stroke, vascular complications), and recurrence patterns.
Patients are stratified based on the site of origin of PVCs (e.g., RVOT subregions, LVOT, aortic cusps, papillary muscles).
Follow-up includes symptom assessment, PVC burden, antiarrhythmic drug use, and mode of follow-up (telephone or in-person). The registry provides a comprehensive overview of clinical outcomes with focal PFA and enables comparison with historical radiofrequency ablation data.
This registry aims to generate robust real-world evidence to inform procedural strategy, patient selection, and safety considerations in PVC ablation using pulsed field energy.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- he study population consists of adult patients (age ≥18 years) with symptomatic premature ventricular contractions undergoing focal monopolar biphasic pulsed field ablation. All patients included must have been treated with the Centauri Generator system and have a minimum of 3 months of follow-up data available at the time of registry entry. The population is expected to be heterogeneous, including patients with and without structural heart disease, and PVCs originating from various anatomical sites. Patients will be enrolled across multiple European electrophysiology centers with varying procedural practices, enhancing the generalizability of the findings.
Key inclusion criteria (3 listed)
- Patients with symptomatic PVCs who underwent focal monopolar biphasic PFA
- Use of Centauri Generator system
- Minimum 3-month clinical follow-up at time of data entry
Key exclusion criteria (2 listed)
- Incomplete procedural or follow-up data
- Patients receiving exclusively RF ablation
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
Freedom from clinically significant PVCs at 6-month follow-up
Time frame: through study completion, an average of 6 months
Clinically significant PVCs are defined as a PVC burden ≥5% on 24-hour Holter ECG. The primary efficacy endpoint is the proportion of patients who achieve a reduction in PVC burden to <5% at 6 months following pulsed field ablation (PFA). PVC burden will be quantified using standardized 24-hour Holter recordings. Patients must not be on any new antiarrhythmic medication during this period to be considered a true efficacy responder.
2 secondary outcomes
Acute Procedural Success
Time frame: Day 0 to Day 2 (during hospital stay)
Periprocedural Complication Rate
Time frame: Day 0 to Day 2 (hospital stay)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Undecided. The decision regarding IPD sharing is currently under review and will depend on institutional policies, ethical approvals.
Related trials for Premature Ventricular Contraction (PVC)
RecruitingObservational study
AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST)
Tachycardia, Paroxysmal Supraventricular Tachycardia
Not yet recruitingObservational study
Premature Ventricular Complex and Diet Inflamatuar Index
Premature Ventricular Complexes, Diet Quality
Recruiting
Disrupted Sleep and Concurrent Ectopy or Atrial Fibrillation
Obstructive Sleep Apnea, Premature Ventricular Contraction (PVC)
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
Recruiting
Catheter Ablation Versus Anti-arrhythmic Drugs for Premature Ventricular Complexes
Premature Ventricular Complexes, Premature Ventricular Contraction (PVC)
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. This study is not recruiting at the moment.
J. Christoph Geller, Prof. Dr. study director
Zentralklinikum Bad berka
Santi Raffa, Dr. study director
Zentralklinik Bad Berka
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 Premature Ventricular Contraction (PVC) and Pulsed Field Ablation, 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: finished, as of the sponsor's last update on 10 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from clinically significant PVCs at 6-month follow-up (time frame: through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2026.