Low-VOLTage Area-Guided Catheter Ablation and SVC Isolation for Persistent Atrial Fibrillation Using a Balloon-in-Basket Pulsed Field Ablation Catheter (LowVOLT-AF)
LowVOLT-AF Study: Low-VOLTage Areas-Guided Catheter Ablation and SVC Isolation for Persistent Atrial Fibrillation Using a Balloon-in-Basket Pulsed Field Ablation Catheter
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Roland R Tilz
- Telefonnummer: +49 451 500-44511
- E-post: roland.tilz@uksh.de
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion criteria
Participants must meet all the following criteria:
- Age ≥18 years
- Persistent AF, defined as continuous AF lasting at least 7 days
- Indication for catheter ablation according to the latest ESC guidelines
- Written informed consent
Exclusion criteria
Participants will be excluded if any of the following criteria apply:
- Inability or unwillingness to provide informed consent
- Continuous AF duration duration of ≥2 years
- Documented atrial tachycardia or atrial flutter
- Previous left atrial catheter ablation or cardiac surgery
- Planned cardiac surgery within the first 3 months after inclusion
- History of heart transplantation, current listing for transplantation, or planned cardiac assist device implantation
- Severe mitral or aortic valvular disease, according to the ESC guidelines
- Platelet count <50,000 cells/mm³
- Body mass index >45 kg/m² or <18 kg/m²
- Untreated thyroid dysfunction (patients may be included once hypothyroidism or hyperthyroidism is adequately treated)
- Absolute contraindication to oral anticoagulation
- Any comorbidity that limits life expectancy to <1 year
- Active systemic infection (enrolment permitted after successful treatment)
- Women who are pregnant or breastfeeding
- Women of childbearing potential not using highly effective contraception (PEARL Index <1%)
- End-stage renal disease (GFR <15 ml/min/1.73 m2) or hepatic failure (Child Pugh C)
- Acutely decompensated heart failure (NYHA IV), inclusion is possible only after stabilization to a NYHA functional status better than IV
- Participation in another randomized controlled trial
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: LVA-guided catheter ablation combined with SVC isolation and PVI
|
SVC isolation
PVI alone
|
|
Aktiv komparator: LVA-guided catheter ablation combined with PVI alone
|
SVC isolation
PVI alone
|
|
Experimentell: SVC isolation and PVI in patients without detectable significant LVA
|
SVC isolation
PVI alone
|
|
Aktiv komparator: PVI alone in patients without detectable significant LVA
|
SVC isolation
PVI alone
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
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.
Tidsram: within 6 months following catheter ablation.
|
within 6 months following catheter ablation.
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2025-544
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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