Atrial ArrhythmiaNCT06106594
VOLT CE Mark Study
A study testing Pulsed Field Ablation in people with Atrial Arrhythmia and Atrial Fibrillation, run by Abbott Medical Devices at 11 sites in 7 countries.
Trial summary
This clinical investigation is intended to demonstrate safety and effectiveness of the Volt™ Pulsed Field Ablation (PFA) Catheter Sensor Enabled™, the Volt™ PFA Generator, Agilis™ NxT Steerable Introducer Dual-Reach™, and EnSite™ X EP System EnSite™ Pulsed Field Ablation Module (for simplicity of reference this device… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Arrhythmia, Atrial Fibrillation, Paroxysmal Atrial Fibrillation
- What is being tested?
- Pulsed Field Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 11 sitesin 7 countries
- Study dates
- 24 Oct 2023to Dec 2026
- 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
- Documented symptomatic PAF or PersAF. Documentation requirements are as follows:
- Paroxysmal:
- Physician's note indicating recurrent self-terminating AF with ≥ 2 episodes of PAF within the 6 months prior to enrollment AND
- One electrocardiographically documented PAF episodes within 12 months prior to enrollment.
- Persistent: Continuous AF sustained beyond 7 days and less than 1 year that is documented by
- Physician's note, AND either
Show all 16Show fewer
- 24-hour Holter within 180-days prior to enrollment, showing continuous AF, OR
- Two electrocardiograms (from any form of rhythm monitoring) showing continuous AF:
- That are taken at least 7 days apart but less than 12 months apart
- If electrograms are more than 12 months apart, there must be one or more Sinus Rhythm recordings in between or within 12 months prior to consent/enrollment
- The most recent electrocardiogram must be within 180 days of enrollment.
- NOTE: Documented evidence of the AF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of AF from another ECG device.
- Plans to undergo a PVI catheter ablation procedure due to symptomatic PAF or PersAF and is refractory, intolerant, or contraindicated to at least one Class I-IV AAD medication
- At least 18 years of age
- Able and willing to comply with all trial requirements including pre-procedure, post- procedure, and follow-up testing and requirements
- Informed of the nature of the trial, agreed to its provisions, and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical trial site.
Who cannot join
- Previously diagnosed long-standing persistent atrial fibrillation (AF greater than 1 year in duration)
- Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, electrolyte imbalance, severe untreated sleep apnea, and other major surgical procedures in the preceding 90 days
- Participant known to require ablation beyond PVI at the time of consent (Main study only)
- Known presence of cardiac thrombus
- Left atrial diameter ≥ 5.5 cm (anteroposterior diameter)
- Left ventricular ejection fraction < 35% as assessed with echocardiography within 180 days of index procedure
Show all 39Show fewer
- New York Heart Association (NYHA) class III or IV heart failure
- Body mass index > 40 kg/m2
- Pregnant, nursing, or planning to become pregnant during the clinical investigation follow-up period
- Patients who have had a ventriculotomy or atriotomy within the preceding 28 days of procedure,
- Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 90 days
- Unstable angina
- Stroke or TIA (transient ischemic attack) within the last 90 days
- Heart disease in which corrective surgery is anticipated within 180 days after procedure
- History of blood clotting or bleeding abnormalities including thrombocytosis, thrombocytopenia, bleeding diathesis, or suspected anti-coagulant sate
- Contraindication to long term anti-thromboembolic therapy
- Patient unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
- Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication
- Previous left atrial surgical or catheter ablation procedure (including LAA closure device)
- Presence of any condition that precludes appropriate vascular access
- Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2).
- Previous tricuspid or mitral valve replacement or repair
- Patients with prosthetic valves
- Patients with a myxoma
- Patients with an interatrial baffle or patch as the transseptal puncture could persist and produce an iatrogenic atrial shunt
- Stent, constriction, or stenosis in a pulmonary vein
- Rheumatic heart disease
- Hypertrophic cardiomyopathy
- Diagnosed with amyloidosis or atrial amyloidosis
- Active systemic infection
- Renal failure requiring dialysis
- Severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
- Presence of an implantable therapeutic cardiac device including permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) or planned implant of such a device for any time during the follow-up period. Presence of an implantable loop recorder is acceptable as long as it is removed prior to insertion of the investigational device.
- Presence of an implanted LAA closure device or plans to have an LAA closure device implanted during the follow-up period
- Patient is currently participating in another clinical trial or has participated in a clinical trial within 30 days prior to screening that may interfere with this clinical trial without pre-approval from this study Sponsor
- Unlikely to survive the protocol follow up period of 12 months
- Presence of other medical, anatomic, comorbid, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
- Individuals without legal authority
- Individuals unable to read or write
Trial locations and contacts
11 sites in 7 countries.
11 sites in 7 countries
Australia4 sites
Royal Adelaide Hospital
Adelaide, Saustrl, 5000
The Prince Hospital
Chermside, Queensl, 4032
Monash Health
Clayton, Victoria, 3168
Royal Melbourne Hospital - City Campus
Parkville, Victoria, 3050
Belgium2 sites
AZ Sint Jan
Bruges, Wflndrs, 8000
UZ Brussel
Brussels, Brussels Capital, 1090
Germany1 site
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, Schlesw, 23562
About this study
This clinical investigation is intended to demonstrate safety and effectiveness of the Volt™ Pulsed Field Ablation (PFA) Catheter Sensor Enabled™, the Volt™ PFA Generator, Agilis™ NxT Steerable Introducer Dual-Reach™, and EnSite™ X EP System EnSite™ Pulsed Field Ablation Module (for simplicity of reference this device collection will hereafter be referred to as the Volt™ PFA system) for the treatment of symptomatic, recurrent, drug-refractory paroxysmal and persistent atrial fibrillation.
Read the detailed description
The main study is a pre-market, prospective, single-arm, non-randomized, multicenter clinical study to demonstrate safety and effectiveness for the treatment of symptomatic, recurrent, drug-refractory Paroxysmal Atrial Fibrillation (PAF) and Persistent Atrial Fibrillation (PersAF). The main study design includes a feasibility sub-study in which additional imaging assessments will be collected in a small cohort of subjects to confirm acute safety of the Volt PFA System in humans.
The enrollment extension will include up to an additional 150 subjects enrolled with market-released or investigational devices, depending on enrollment geography.
- Conditions
- Atrial Arrhythmia, Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
- Being tested
- Pulsed Field Ablation
- Keywords
- Atrial Arrhythmia, Pulsed Field Ablation, Paroxysmal AF, PFA, Persistent Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Field AblationDevice
Pulsed field ablation using the Volt PFA System
| Study group | Role | What they receive |
|---|---|---|
| Volt PFA Catheter Sensor Enabled (SE) | Experimental | Not described Receives: Device: Pulsed Field Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of subjects experiencing a device and/or procedure-related serious adverse event with onset within 7-days of any ablation procedure that uses the Volt PFA System.
Serious adverse events are defined as:
- Atrio-esophageal fistula
- Cardiac tamponade/perforation
- Death
- Heart block
- Myocardial infarction
- Pericarditis
- Phrenic nerve injury resulting in permanent diaphragmatic paralysis
- Pulmonary edema
- Pulmonary vein stenosis
- Stroke/cerebrovascular accident
- Thromboembolism
- Transient ischemic attack
- Vagal nerve injury/gastroparesis
- Major vascular access complications / major bleeding events
- Device and/or procedure related cardiovascular and/or pulmonary adverse event that prolongs hospitalization for more than 48 hours (excluding hospitalization solely for arrhythmia recurrence or non-urgent cardioversion)
Measured: 7-days
Acute procedural effectiveness summarized as the rate of pulmonary veins treated with the Volt PFA system that are isolated at the end of the index ablation procedure.
Acute procedural failure for each pulmonary vein is defined as any of the following:
- Inability to isolate a pulmonary vein at the end of the index ablation procedure. Isolation will be assessed via confirmation of electrical isolation in each ablated pulmonary vein after a minimum waiting period of 20 minutes via entrance block at a minimum. Touch-up ablation to achieve isolation will be allowed for any pulmonary vein reconnection detected during the index procedure with the investigational catheter (to the maximum delivery allowed per vein) and will not be considered a failure.
- Any use of a non-study ablation device for pulmonary vein isolation.
Measured: During procedure
Long-term 6-month effectiveness summarized as the rate of freedom from documented AF/AFL/AT episodes of >30 seconds duration after the index ablation procedure through 6 months of follow-up.
The situations in which subjects will be considered long-term effectiveness endpoint failures:
- Acute procedural failure
- Any use of a non-study ablation device for pulmonary vein isolation or to deliver ablation lesions in the left atrium during the index procedure or during the first repeat procedure.
- If documented AF/AFL/AT recurrence occurs at any time after the blanking period
- If subject requires a repeat procedure for the treatment of AF, non-CTI-dependent AFL, or AT after the blanking period or a second repeat AF ablation procedure at any time after the index ablation procedure.
- Any use of a new class I or III AAD for AF after the blanking period.
- Any use of a class I or III AAD for AF at a dose higher than the historical maximum dose for the subject after the blanking period.
- If the subject requires a cardioversion for the treatment of AF/AFL/AT after the blanking period
- Surgical treatment of AF/AFL/AT post index procedure.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start24 Oct 2023
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial ArrhythmiaStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Sequential
- Model description
- Main study enrollment will include up to 150 subjects, enrollment extension cohort will include up to 100 subjects.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristin Ruffner, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106594
- Sponsor's protocol ID
- ABT-CIP-10456
- Status last verified
- Apr 2026
- First submitted
- 16 Oct 2023
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Tilz RR, Chierchia GB, Gunawardene M, Sanders P, Haqqani H, Kalman J, Healy S, Purerfellner H, Neuzil P, Asensi JO, Loh P, Reddy VY, Knecht S, Jesser E, Dirckx N, Miller A, Walker D, Lakkireddy D. Safety and effectiveness of the first balloon-in-basket pulsed field ablation system for the treatment of atrial fibrillation: VOLT CE Mark Study 6-month results. Europace. 2025 Mar 28;27(4):euaf072. doi: 10.1093/europace/euaf072.
PubMed 40163671Sanders P, Healy S, Emami M, Kotschet E, Miller A, Kalman JM. Initial clinical experience with the balloon-in-basket pulsed field ablation system: acute results of the VOLT CE mark feasibility study. Europace. 2024 May 2;26(5):euae118. doi: 10.1093/europace/euae118.
PubMed 38701222
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VOLT CE Mark Study
- ClinicalTrials.gov ID
- NCT06106594
- Acronym / sponsor ID
- ABT-CIP-10456
- Conditions
- Atrial Arrhythmia, Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
- Keywords
- Atrial Arrhythmia, Pulsed Field Ablation, Paroxysmal AF, PFA, Persistent Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Oct 2023 (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.
This clinical investigation is intended to demonstrate safety and effectiveness of the Volt™ Pulsed Field Ablation (PFA) Catheter Sensor Enabled™, the Volt™ PFA Generator, Agilis™ NxT Steerable Introducer Dual-Reach™, and EnSite™ X EP System EnSite™ Pulsed Field Ablation Module (for simplicity of reference this device collection will hereafter be referred to as the Volt™ PFA system) for the treatment of symptomatic, recurrent, drug-refractory paroxysmal and persistent atrial fibrillation.
Detailed description
The main study is a pre-market, prospective, single-arm, non-randomized, multicenter clinical study to demonstrate safety and effectiveness for the treatment of symptomatic, recurrent, drug-refractory Paroxysmal Atrial Fibrillation (PAF) and Persistent Atrial Fibrillation (PersAF). The main study design includes a feasibility sub-study in which additional imaging assessments will be collected in a small cohort of subjects to confirm acute safety of the Volt PFA System in humans.
The enrollment extension will include up to an additional 150 subjects enrolled with market-released or investigational devices, depending on enrollment geography.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Main study enrollment will include up to 150 subjects, enrollment extension cohort will include up to 100 subjects.
| Arm | Type | Receives |
|---|---|---|
| Volt PFA Catheter Sensor Enabled (SE) | Experimental | Device: Pulsed Field Ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Documented symptomatic PAF or PersAF. Documentation requirements are as follows:
- Persistent: Continuous AF sustained beyond 7 days and less than 1 year that is documented by
- NOTE: Documented evidence of the AF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of AF from another ECG device.
- Plans to undergo a PVI catheter ablation procedure due to symptomatic PAF or PersAF and is refractory, intolerant, or contraindicated to at least one Class I-IV AAD medication
- At least 18 years of age
Key exclusion criteria (39 listed)
- Previously diagnosed long-standing persistent atrial fibrillation (AF greater than 1 year in duration)
- Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, electrolyte imbalance, severe untreated sleep apnea, and other major surgical procedures in the preceding 90 days
- Participant known to require ablation beyond PVI at the time of consent (Main study only)
- Known presence of cardiac thrombus
- Left atrial diameter ≥ 5.5 cm (anteroposterior diameter)
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 |
|---|---|---|
| Pulsed Field AblationPulsed field ablation using the Volt PFA System | Device | Volt PFA Catheter Sensor Enabled (SE) |
Primary outcome
Rate of subjects experiencing a device and/or procedure-related serious adverse event with onset within 7-days of any ablation procedure that uses the Volt PFA System.
Time frame: 7-days
Serious adverse events are defined as: * Atrio-esophageal fistula * Cardiac tamponade/perforation * Death * Heart block * Myocardial infarction * Pericarditis * Phrenic nerve injury resulting in permanent diaphragmatic paralysis * Pulmonary edema * Pulmonary vein stenosis * Stroke/cerebrovascular accident * Thromboembolism * Transient ischemic attack * Vagal nerve injury/gastroparesis * Major vascular access complications / major bleeding events * Device and/or procedure related cardiovascular and/or pulmonary adverse event that prolongs hospitalization for more than 48 hours (excluding hospitalization solely for arrhythmia recurrence or non-urgent cardioversion)
Acute procedural effectiveness summarized as the rate of pulmonary veins treated with the Volt PFA system that are isolated at the end of the index ablation procedure.
Time frame: During procedure
Acute procedural failure for each pulmonary vein is defined as any of the following: 1. Inability to isolate a pulmonary vein at the end of the index ablation procedure. Isolation will be assessed via confirmation of electrical isolation in each ablated pulmonary vein after a minimum waiting period of 20 minutes via entrance block at a minimum. Touch-up ablation to achieve isolation will be allowed for any pulmonary vein reconnection detected during the index procedure with the investigational catheter (to the maximum delivery allowed per vein) and will not be considered a failure. 2. Any use of a non-study ablation device for pulmonary vein isolation.
Long-term 6-month effectiveness summarized as the rate of freedom from documented AF/AFL/AT episodes of >30 seconds duration after the index ablation procedure through 6 months of follow-up.
Time frame: 6 months
The situations in which subjects will be considered long-term effectiveness endpoint failures: * Acute procedural failure * Any use of a non-study ablation device for pulmonary vein isolation or to deliver ablation lesions in the left atrium during the index procedure or during the first repeat procedure. * If documented AF/AFL/AT recurrence occurs at any time after the blanking period * If subject requires a repeat procedure for the treatment of AF, non-CTI-dependent AFL, or AT after the blanking period or a second repeat AF ablation procedure at any time after the index ablation procedure. * Any use of a new class I or III AAD for AF after the blanking period. * Any use of a class I or III AAD for AF at a dose higher than the historical maximum dose for the subject after the blanking period. * If the subject requires a cardioversion for the treatment of AF/AFL/AT after the blanking period * Surgical treatment of AF/AFL/AT post index procedure.
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 6 May 2026.
- Results publication: PubMed 40163671Tilz RR, Chierchia GB, Gunawardene M, Sanders P, Haqqani H, Kalman J, Healy S, Purerfellner H, Neuzil P, Asensi JO, Loh P, Reddy VY, Knecht S, Jesser E, Dirckx N, Miller A, Walker D, Lakkireddy D. Safety and effectiveness of the first balloon-in-basket pulsed field ablation system for the treatment of atrial fibrillation: VOLT CE Mark Study 6-month results. Europace. 2025 Mar 28;27(4):euaf072. doi: 10.1093/europace/euaf072.
- Results publication: PubMed 38701222Sanders P, Healy S, Emami M, Kotschet E, Miller A, Kalman JM. Initial clinical experience with the balloon-in-basket pulsed field ablation system: acute results of the VOLT CE mark feasibility study. Europace. 2024 May 2;26(5):euae118. doi: 10.1093/europace/euae118.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Kristin Ruffner study director
Abbott
11 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Field Ablation in people with Atrial Arrhythmia and Atrial Fibrillation, run by Abbott Medical Devices at 11 sites in 7 countries.
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 16 inclusion and 39 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: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Australia, Belgium, Austria, Czechia, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of subjects experiencing a device and/or procedure-related serious adverse event with onset within 7-days of any ablation procedure that uses the Volt PFA System. (time frame: 7-days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06106594, which also lists 2 linked publications.
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 6 May 2026.