None listed
Conditions
Brief summary
This study aims to evaluate whether the ElectroPulse PFA System (which delivers energy to scar areas of the heart tissue causing abnormal rhythms, so the heart beats normally again) is a safe and effective treatment for people with atrial fibrillation (AF), a common heart rhythm disorder. The results will help support global regulatory approval of the system.
Interventions
The ElectroPulse Pulsed Field Ablation (PFA) System is a medical device which is used to perform cardiac catheter ablation. The ElectroPulse PFA System consists of the following components: (1) ElectroPulse Pulsed Field Ablation Generator, (2) ElectroPulse Pulsed Field Ablation Catheters, (3) ElectroPulse Pulsed Field Ablation Extension Cable.
Index Procedure
At index procedure a specialist cardiologist called an electrophysiologist guides a tube called a catheter into the patient heart and use
The ElectroPulse Pulsed Field Ablation (PFA) System is a medical device which is used to perform cardiac catheter ablation. The ElectroPulse PFA System consists of the following components: (1) ElectroPulse Pulsed Field Ablation Generator, (2) ElectroPulse Pulsed Field Ablation Catheters, (3) ElectroPulse Pulsed Field Ablation Extension Cable. Index Procedure At index procedure a specialist cardiologist called an electrophysiologist guides a tube called a catheter into the patient heart and uses energy to ablate (i.e. remove) small areas of tissue/nerves responsible for creating the faulty electrical signals that may be causing the irregular heartbeat or atrial fibrillation. The procedure is carried out in an operating room under full anaesthesia and takes 1-4 hours. The procedure preparation and progress are identical to all standard catheter ablation procedures currently performed for atrial fibrillation. During the procedure, the heart will also be ‘mapped’ in a 3D manner, which is a procedure to assess the electrical function of the heart to help the clinical team locate what region of the heart is causing faulty electrical signals in the heart and contributing to the patient's atrial fibrillation. This is done by guiding a commercially available diagnostic catheter (tube) into the heart via a hole in the groin. The experimental component of the study is the use of the ElectroPulse PFA System to undertake the ablation aspect of the procedure. Reablation Procedure If a participant continues to experience atrial fibrillation symptoms within 60 days, and the investigator deems it necessary, the participant will undergo a Remap Procedure to assess whether the initial ablation procedure was successful and new areas of arrhythmia have been formed, or if the initial procedure was unsuccessful. If the cardiac electrophysiologist believes it is required, a commercial device will be used to perform additional ablations. The Remap Procedure is carried out in an operating room under full anaesthesia by a cardiac electrophysiologist (usually the same doctor that perform the Index Procedure) and may take 1-4 hours. Procedural data will be captured in Case Report Forms by the study team, and will include the location and number of ablations performed. Cases will also be video recorded with the consent of the participant for case review in the future. The study will enroll three separate cohorts for regulatory purposes: 1. Persistent AF Cohort – Up to 150 participants diagnosed with persistent atrial fibrillation. 2. Paroxysmal AF Cohort – Up to 150 participants diagnosed with paroxysmal atrial fibrillation. 3. Roll-in Cohort – Up to 100 participants who will be the first treated by each investigator to allow familiarisation with the procedure or device. Although these cohorts are defined separately for regulatory tracking, all participants will be analysed together in the overall study analysis.
Sponsors
CathRx Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
All participants are required to meet all the following inclusion criteria to be considered eligible for participation in this study: 1. Failure of at least one AAD (class I or III) for AF as evidenced by recurrent symptomatic AF, or intolerable side effects due to AAD. 2. Age between 18 and 80 at the time of informed consent (or older than 18 if required by local law). 3. A diagnosis of recurrent symptomatic paroxysmal or persistent AF: a) Symptomatic paroxysmal AF which is defined as AF that terminates spontaneously or with intervention within seven days of onset, documented by the following: i) Physician’s note indicating at least two symptomatic paroxysmal AF episodes occurring within six months prior to enrolment; and ii) At least one ECG documented AF episode from any form of rhythm monitoring within 12 months prior to enrolment (can include episodes recorded on a validated wearable). OR b) Symptomatic persistent AF, which is defined as continuous AF sustained beyond 7 days and less than one year, documented by the following: i) Physician’s note indicating at least one symptomatic persistent AF episode occurring within six months prior to enrolment; and ii) Any 24-hour continuous ECG recording documenting continuous AF within six months prior to enrolment; OR Two ECGS from any form of rhythm monitoring taken at least seven days apart, both showing continuous AF within six months prior to enrolment (can include episodes recorded on a validated wearable). 4. Able and willing to comply with all trial requirements including pre-procedure, post-procedure and follow up testing and requirements
Exclusion criteria
Patients will be excluded from participating in this study if they meet any one of the following exclusion criteria: 1. Known reversible causes of AF, including but not limited to uncontrolled hyperthyroidism, severe untreated obstructive sleep apnoea, and acute alcohol toxicity 2. Long-standing persistent or permanent AF (continuous AF that is sustained greater than 12 months) 3. Previous left atrial ablation or surgical procedure 4. Left atrial diameter greater than 5.5 cm (anteroposterior) measured within 180 days of index procedure 5. Presence of an implanted LAA closure device, permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function). Note that presence of an implantable loop recorder is acceptable as long as it is removed prior to insertion of the investigational device 6. Planned LAA closure procedure or implant of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without pacing function) for any time during the follow-up period 7. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI) or valve or coronary bypass grafting surgery within 90 days of the consent date 8. Pre-existing stent, constriction or stenosis in a pulmonary vein 9. Presence of any cardiac valve prosthesis 10. Rheumatic heart disease 11. Severe mitral regurgitation (regurgitant volume greater than or equal to 60 mL/beat, regurgitant fraction greater than or equal to 50%, and/or effective regurgitant orifice area greater than or equal to 0.40cm2). 12. Moderate to severe mitral stenosis (mitral valve area of less than 1.5cm2) calculated from the screening echocardiogram 13. Severe atrial dilation defined by a Left Atrial Volume Index (LAVI) of less than or equal to 50mL/m2 calculated from the screening echocardiogram 14. History of blood clotting or bleeding abnormalities including thrombocytosis, thrombocytopenia, bleeding diathesis, or suspected anti-coagulant state 15. Unstable angina 16. Active systemic infection 17. History of any cerebral ischemic events (stroke or TIA) or thromboembolic events or evidence of intracardiac thrombus within six months of the date of consent 18. New York heart Association (NYHA) function class III or IV congestive heart failure or documented left ventricular ejection fraction (LVEF) less than or equal to 35% measure by acceptable cardiac testing (e.g. TTE) 19. Body mass index greater than 40 Kg/m2. 20. Estimate glomerular filtration rate (eGFR) less than 35 mL/min/1.73 m2 or has ever received renal dialysis or transplant. 21. Severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lunge or respiratory system that produces severe chronic symptoms including, but not limited to primary pulmonary hypertension (defined as pulmonary systolic artery pressure greater than 50mm Hg) 22. Any other significant uncontrolled or unstable medical condition (such as uncontrolled brady-arrhythmias, ventricular arrhythmias, or significant coagulopathy). 23. Hemodynamically significant valvular disease, atrial or ventricular septal defect closure, atrial myxoma and/or significant or symptomatic hypotension. 24. Life expectancy less than one year. 25. Contraindication to anticoagulation (i.e., heparin, direct acting oral anticoagulation, Vitamin K Antagonist). 26. Hypertrophic cardiomyopathy 27. Women who are currently pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence 28. Presence of other medical, anatomic, comorbid, social or psychological conditions that, in the investigator’s opinion, could limit the participant’s ability to participate in the clinical investigation or comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results 29. Unable to provide informed consent or unwilling or unable to comply fully with study procedures and follow-up. 30. Current or anticipated enrolment in another clinical trial of a drug, device or biologic during the duration of the study not pre-approved by CathRx
Outcome results
None listed