REal-world Valued Outcomes of a noveL Balloon-in-basket pUlsed Field ablaTION Catheter for Atrial Fibrillation RegistrY
Recruiting · NCT07459387 · Interventional (participants receive a specific treatment) · Lead sponsor: Cardioangiologisches Centrum Bethanien
View the official record on ClinicalTrials.gov →Interventions studied
PFA Ablation
What this trial is about
describe real-world adaption, work-flow data as well as procedural and follow-up outcomes after balloon-in-basket guided PFA for AF in early European users.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- All patients who underwent an AF catheter ablation procedure using the novel balloon-in-basket VOLT PFA system will be included into the analysis.
- Age ≥ 18 years
- Subject is able and willing to give informed consent
Exclusion criteria
- LA-Diameter \> 60mm
- Severe mitral stenosis or regurgitation, prior mitral valve reconstruction or replacement
- Any condition or disease, which is contraindication for AF ablation, up to the assessment of the investigator
- Known intra-cardiac thrombus formation Any contraindication for oral anticoagulation
- Any untreated or uncontrolled hyperthyroidism or other reversible causes for AF like alcoholism
- Pregnant or breastfeeding woman or woman of childbearing potential not on adequate birth control
- Active systemic infection
Where it is running
1 location listed.
- Mvz Ccb Am Agaplesion Markus Krankenhaus - Frankfurt, Germany