NCT07587541Not yet recruiting
Low-VOLTage Area-Guided Catheter Ablation and SVC Isolation for Persistent Atrial Fibrillation Using a Balloon-in-Basket Pulsed Field Ablation Catheter
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
Source: ClinicalTrials.gov · Last updated 19 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 618 (estimated)
- First submitted
- 7 May 2026
- Start date
- 18 May 2026
- Primary completion date
- 1 Nov 2029
- Lead sponsor
- University of Luebeck
- Diseases
- Atrial fibrillation
- NCT number
- NCT07587541
What you commit to
- Study type: Interventional
- Planned participants: 618
- From 18 May 2026 to the primary completion date, 1 Nov 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous left atrial catheter ablation or cardiac surgery
Other illness
- 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
- Active systemic infection (enrolment permitted after successful treatment)
- Acutely decompensated heart failure (NYHA IV), inclusion is possible only after stabilization to a NYHA functional status better than IV
Lab values
- Platelet count \<50,000 cells/mm³
- End-stage renal disease (GFR \<15 ml/min/1.73 m2) or hepatic failure (Child Pugh C)
Age
- Continuous AF duration duration of ≥2 years
Other
- Participants will be excluded if any of the following criteria apply:
- Inability or unwillingness to provide informed consent
- Documented atrial tachycardia or atrial flutter
- 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
- Women who are pregnant or breastfeeding
- Women of childbearing potential not using highly effective contraception (PEARL Index \<1%)
- Participation in another randomized controlled trial
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.