Atrial Fibrillation (AF)
Conditions
Brief summary
The primary objective of this study is to determine whether low-voltage areas (LVA)-guided catheter ablation combined with superior vena cava (SVC) isolation and pulmonary vein isolation (PVI), performed using the balloon-in-basket Volt™ pulsed field ablation PFA system, is superior to PVI alone using same technology in reducing arrhythmia recurrence at 6 and 12 months in patients with persistent AF and detectable significant LVAs on three-dimensional electroanatomical mapping. Moreover, the study will investigate, in a separate randomized cohort, the effect of adding SVC isolation to PVI using the balloon-in-basket Volt™ PFA system, compared with PVI alone, in patients with persistent AF without detectable significant LVAs during three-dimensional electroanatomical mapping.
Interventions
DEVICEVolt™ Pulsed Field Ablation System
SVC isolation
Sponsors
University of Luebeck
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants must meet all the following criteria: 1. Age ≥18 years 2. Persistent AF, defined as continuous AF lasting at least 7 days 3. Indication for catheter ablation according to the latest ESC guidelines 4. Written informed consent
Exclusion criteria
Participants will be excluded if any of the following criteria apply: 1. Inability or unwillingness to provide informed consent 2. Continuous AF duration duration of ≥2 years 3. Documented atrial tachycardia or atrial flutter 4. Previous left atrial catheter ablation or cardiac surgery 5. Planned cardiac surgery within the first 3 months after inclusion 6. History of heart transplantation, current listing for transplantation, or planned cardiac assist device implantation 7. Severe mitral or aortic valvular disease, according to the ESC guidelines 8. Platelet count \<50,000 cells/mm³ 9. Body mass index \>45 kg/m² or \<18 kg/m² 10. Untreated thyroid dysfunction (patients may be included once hypothyroidism or hyperthyroidism is adequately treated) 11. Absolute contraindication to oral anticoagulation 12. Any comorbidity that limits life expectancy to \<1 year 13. Active systemic infection (enrolment permitted after successful treatment) 14. Women who are pregnant or breastfeeding 15. Women of childbearing potential not using highly effective contraception (PEARL Index \<1%) 16. End-stage renal disease (GFR \<15 ml/min/1.73 m2) or hepatic failure (Child Pugh C) 17. Acutely decompensated heart failure (NYHA IV), inclusion is possible only after stabilization to a NYHA functional status better than IV 18. Participation in another randomized controlled trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence of atrial arrhythmias defined as atrial fibrillation, atrial flutter or atrial tachycardia lasting ≥30 seconds occurring after a 2-month post-procedural blanking period. | within 6 months following catheter ablation. |
Contacts
CONTACTRoland R Tilz
Outcome results
None listed