Atrial Fibrillation (AF)LowVOLT-AFNCT07587541
Low-VOLTage Area-Guided Catheter Ablation and SVC Isolation for Persistent Atrial Fibrillation Using a Balloon-in-Basket Pulsed Field Ablation Catheter
A study testing Volt™ Pulsed Field Ablation System in people with Atrial Fibrillation (AF), run by University of Luebeck.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Volt™ Pulsed Field Ablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 618 participants
- Where
- No sites listed yet
- Study dates
- 18 May 2026to 1 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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)
- Being tested
- Volt™ Pulsed Field Ablation System
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volt™ Pulsed Field Ablation SystemDevice
SVC isolation
Volt™ Pulsed Field Ablation SystemDevice
PVI alone
| Study group | Role | What they receive |
|---|---|---|
| LVA-guided catheter ablation combined with SVC isolation and PVI | Experimental | Not described Receives: Device: Volt™ Pulsed Field Ablation System |
| LVA-guided catheter ablation combined with PVI alone | Active comparator | Not described Receives: Device: Volt™ Pulsed Field Ablation System |
| SVC isolation and PVI in patients without detectable significant LVA | Experimental | Not described Receives: Device: Volt™ Pulsed Field Ablation System |
| PVI alone in patients without detectable significant LVA | Active comparator | Not described Receives: Device: Volt™ Pulsed Field Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 6 months following catheter ablation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start18 May 2026 (estimated)
- Primary completion1 Nov 2029 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 618 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roland Richard Tilz, MD, University of Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07587541
- Sponsor's protocol ID
- 2025-544
- Acronym
- LowVOLT-AF
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07587541
- Acronym / sponsor ID
- LowVOLT-AF / 2025-544
- Conditions
- Atrial Fibrillation (AF)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 618 participants (estimated)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- 18 May 2026 (estimated)
- Primary completion
- 1 Nov 2029 (estimated)
- Study completion
- 1 Nov 2029 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volt™ Pulsed Field Ablation SystemSVC isolation | Device | LVA-guided catheter ablation combined with SVC isolation and PVI, SVC isolation and PVI in patients without detectable significant LVA |
| Volt™ Pulsed Field Ablation SystemPVI alone | Device | LVA-guided catheter ablation combined with PVI alone, PVI alone in patients without detectable significant LVA |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Volt™ Pulsed Field Ablation System in people with Atrial Fibrillation (AF), run by University of Luebeck.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roland R Tilz (+49 451 500-44511, roland.tilz@uksh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.