Menu
Not yet recruiting NCT07587541

Low-VOLTage Area-Guided Catheter Ablation and SVC Isolation for Persistent Atrial Fibrillation Using a Balloon-in-Basket Pulsed Field Ablation Catheter

No phase Interventional Atrial Fibrillation (AF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Volt™ Pulsed Field Ablation System, Volt™ Pulsed Field Ablation System.
Who it may be relevant to
Registry conditions: Atrial Fibrillation (AF). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Device Volt™ Pulsed Field Ablation System
    SVC isolation
  • Device Volt™ Pulsed Field Ablation System
    PVI alone

Primary outcome measures

  • 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. [Time frame: within 6 months following catheter ablation.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07587541 · 2025-544

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗