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

NCT07587541 | Not Yet Recruiting

• 1 other identifier: 2025-544
• Study Type: interventional
• Target: 618
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation (AF)

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (4)

LVA-guided catheter ablation combined with SVC isolation and PVI

EXPERIMENTAL

Device: Volt™ Pulsed Field Ablation System

LVA-guided catheter ablation combined with PVI alone

ACTIVE COMPARATOR

Device: Volt™ Pulsed Field Ablation System

SVC isolation and PVI in patients without detectable significant LVA

EXPERIMENTAL

Device: Volt™ Pulsed Field Ablation System

PVI alone in patients without detectable significant LVA

ACTIVE COMPARATOR

Device: Volt™ Pulsed Field Ablation System

Interventions

Volt™ Pulsed Field Ablation System DEVICE

SVC isolation

LVA-guided catheter ablation combined with SVC isolation and PVI; SVC isolation and PVI in patients without detectable significant LVA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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%)

Sponsors & Collaborators

• University of Luebeck: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Roland R Tilz

CONTACT

+49 451 500-44511; roland.tilz@uksh.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Rhythmology, University Heart Center Lübeck

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 14, 2026
• Study Start: May 18, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: May 19, 2026

Record last verified: 2026-05