BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF

Overview

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.

Interventions

• Device Pulsed Field Ablation
  Pulsed Field Ablation using the Volt PFA System

Primary outcome measures

• 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 [Time frame: 7 days]
• Long-term Effectiveness will be the proportion of subjects with freedom from documented AF/AFL/AT recurrence through 12-months. [Time frame: During procedure]
• Acute procedural effectiveness is defined as confirmation of entrance block in all targeted pulmonary veins [Time frame: During procedure]

Eligibility criteria

Inclusion criteria

• 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
• 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.

Exclusion criteria

• 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
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

Germany · 4 centers

• Herz-und Diabetes Zentrum NRW — Bad Oeynhausen
• Medizinische Einrichtungen der Universität zu Köln — Cologne
• Asklepios Klinik St. Georg — Hamburg
• TUM Klinikum - Deutsches Herzzentrum München — München

France · 3 centers

• Hôpital Pitié Salpetrière — Paris
• Hopital Haut Leveque — Pessac
• Clinique Pasteur Toulouse — Toulouse

Spain · 3 centers

• Hospital Universitario A Coruña — A Coruña
• Hospital Universitario Doce de Octubre — Madrid
• Hospital Universitari i Politècnic La Fe — Valencia

Belgium · 2 centers

• AZ Sint Jan — Bruges
• UZ Brussel — Brussels

Italy · 2 centers

• Az. Osp.Universitaria Osp.Riuniti Umberto I-Lancisi-Salesi — Ancona
• Centro Cardiologico Monzino — Milan

Netherlands · 2 centers

• Universitair Medisch Centrum Groningen — Groningen
• St. Antonius Ziekenhuis — Nieuwegein

Austria · 1 center

• Ordensklinikum Linz Elisabethinen — Linz

Denmark · 1 center

• Rigshospitalet — Copenhagen

Ireland · 1 center

• Mater Private Hospital — Dublin

Poland · 1 center

• National Institute of Cardiology Warsaw — Warsaw

Portugal · 1 center

• ULS de Lisboa Ocidental — Lisbon

Sweden · 1 center

• Karolinska University Hospital Huddinge — Stockholm

Identifiers

NCT: NCT07181590 · ABT-CIP-10608

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗