Paroxysmal AFBLAST-OFFNCT07181590
BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF
A study testing Pulsed Field Ablation in people with Paroxysmal AF and Atrial Arrhythmia, run by Abbott Medical Devices at 22 sites in 12 countries.
Trial summary
This study is designed to obtain real-world clinical evidence on the safety and effectiveness of the Volt PFA System in various use cases, with a sub study designed to address additional clinical evidence needs in electrophysiology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal AF, Atrial Arrhythmia, 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
- 22 sitesin 12 countries
- Study dates
- 11 Dec 2025to Sep 2027
- Phase
- Interventional
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 AND
- One electrocardiographically documented PAF episode 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
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- 24-hour Holter within 360 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 de novo ablation procedure with the Volt PFA Catheter 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
- 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
- Known presence of cardiac thrombus
- Known Left ventricular ejection fraction < 35% as assessed with echocardiography within 360 days of index procedure
- New York Heart Association (NYHA) class III or IV heart failure
- 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 30 days of procedure
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- 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 state
- Contraindication to long term anti-thromboembolic therapy
- Patient unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
- Previous left atrial surgical or left atrial catheter ablation procedure (including LAA closure device)
- 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 implanted LAA closure device
- Patient is currently participating in another clinical study that may confound the results of this of this post market evaluation; for example, enrolled in another study with an active treatment arm
- 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
22 sites in 12 countries.
22 sites in 12 countries
Germany4 sites
Herz-und Diabetes Zentrum NRW
Bad Oeynhausen, 32545
Medizinische Einrichtungen der Universität zu Köln
Cologne, 50937
Asklepios Klinik St. Georg
Hamburg, 20099
TUM Klinikum - Deutsches Herzzentrum München
München, 80636
France3 sites
Hôpital Pitié Salpetrière
Paris, 75013
Hopital Haut Leveque
Pessac, 33600
Clinique Pasteur Toulouse
Toulouse, 31076
Spain3 sites
Hospital Universitario A Coruña
A Coruña, 15006
Hospital Universitario Doce de Octubre
Madrid, 28041
Hospital Universitari i Politècnic La Fe
Valencia, 46026
Italy2 sites
Az. Osp.Universitaria Osp.Riuniti Umberto I-Lancisi-Salesi
Ancona, 60126
Centro Cardiologico Monzino
Milan, 20138
Netherlands2 sites
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
St. Antonius Ziekenhuis
Nieuwegein, 3435 CM
About this study
This study is designed to obtain real-world clinical evidence on the safety and effectiveness of the Volt PFA System in various use cases, with a sub study designed to address additional clinical evidence needs in electrophysiology.
- Being tested
- Pulsed Field Ablation
- Keywords
- Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Pulsed Field Ablation, Persistent Field Ablation
- 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) | Other | Patients diagnosed with drug refractory, symptomatic, recurrent, paroxysmal and persistent atrial fibrillation that will undergo a de novo ablation procedure with the Volt PFA Catheter. 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 Volt AF
Serious adverse events are defined as:
- Atrio-esophageal fistula
- Cardiac tamponade/perforation
- Death
- Heart block
- Myocardial infarction
- Pericarditis3
- Phrenic nerve injury resulting in permanent diaphragmatic paralysis
- Pulmonary Edema
- Pulmonary vein stenosis1
- Stroke
- Thromboembolism
- Transient ischemic attack
- Vagal nerve injury/gastroparesis
- Major vascular access complications4 / major bleeding events5
- Device 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
Long-term Effectiveness will be the proportion of subjects with freedom from documented AF/AFL/AT recurrence through 12-months.
Other situations in which subjects will be considered effectiveness endpoint failures include:
- Cardioversion (electrical or pharmaceutical) for the treatment of AF/AFL/AT following the blanking period.
- A second repeat procedure for ablation of AF recurrence within the 90-day blanking period
- Any repeat ablation procedure in the left atrium (LA) for AF/AFL/AT following the 90-day blanking period
- Any use of a new class I or III AAD for AF/AFL/AT after the 90-day blanking period
- Any use of a class I or III AAD for AF/AFL/AT at a dose higher than the historical maximum dose for the subject after the blanking period.
Measured: During procedure
Acute procedural effectiveness is defined as confirmation of entrance block in all targeted pulmonary veins
A secondary measure of confirmation to include any one of the following (the same method must be used for all pulmonary veins) :
- A minimum 20-minute wait following initial confirmation of entrance block with a second confirmation of entrance block following the 20-minute wait; or
- Exit block pacing maneuvers ; or
- Isoproterenol or adenosine challenge
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start11 Dec 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal AFStudies 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
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah C Kammer, Study director, Abbott Medical Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181590
- Sponsor's protocol ID
- ABT-CIP-10608
- Acronym
- BLAST-OFF
- Status last verified
- Oct 2026
- First submitted
- 12 Sep 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No