None listed
Conditions
Brief summary
The purpose of the study is to provide data demonstrating the safety and effectiveness of the ElectroPulse PFA System for the treatment of atrial fibrillation. In particular, the study will provide first in human insights into clinical safety and device function of the ElectroPulse PFA System for pulmonary vein isolation as a treatment for atrial fibrillation.
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.
No ablation will be performed at the Remap Procedure unless there is documented clinical recurrence of AF. Data will continue to be collected from these P
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. No ablation will be performed at the Remap Procedure unless there is documented clinical recurrence of AF. Data will continue to be collected from these Participants who undergo repeat ablation. 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. Remap Procedure The Remap Procedure is an additional cardiac mapping procedure (“re-mapping”), performed 3-6 months after the initial cardiac ablation procedure (Index Procedure), to assess how effective the Index Procedure with the ElectroPulse PFA System was. The preparation and progress of the Remap Procedure are identical to the Index Procedure or 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 atrial fibrillation. This is done by guiding a commercially available diagnostic catheter (tube) into the heart via a small hole in the groin. The only difference is that no ablation therapy is reapplied or delivered unless required. 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. An independent Contract Research Organisation (CRO) has been employed to monitor the study. The CRO will review all data collected from the source medical records held. The CRO will ensure the study is followed per protocol and all local regulations.
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 No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria: All participants are required to meet all the following inclusion criteria to be considered eligible for participation in this study: 1. Age > 18 2. Able to provide written consent. 3. Paroxysmal or persistent atrial fibrillation meeting the criteria for ablative intervention based on the current guidelines: 3.1. Participants who have failed at least one AAD (class I or III) for AF as evidenced by recurrent symptomatic paroxysmal or persistent AF, or intolerable side effects due to AAD. 3.2. 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 7 days of onset, documented by the following: i) Physician's note indicating at least 1 symptomatic paroxysmal AF episodes occurring within 6 months prior to enrolment; and ii) at least 1 ECG documented AF episode from any form of rhythm monitoring within 12 months prior to enrolment. Documentation may include ECG, Holter monitor or telemetry strip OR b) Symptomatic persistent AF, which is defined as continuous AF sustained beyond 7 days and less than 1 year, documented by the following: i) Physician's note indicating at least 1 symptomatic persistent AF episode occurring within 6 months prior to enrolment; and ii) any 24-hour continuous ECG recording documenting continuous AF within 6 months prior to enrolment; OR 2 ECGs from any form of rhythm monitoring taken at least 7 days apart, both showing continuous AF within 6 months prior to enrolment. Documentation may include ECG, Holter monitor or telemetry strip. 4. Women of childbearing potential (WOCBP) must be using at least one acceptable method of contraception from baseline to the six-month follow-up visit.
Exclusion criteria
Exclusion Criteria: 1. Secondary AF- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause such as acute alcohol toxicity 2. Long-standing persistent or permanent AF (continuous AF that is sustained >12 months) 3. Patient with previous ablation or surgery for AF 4. Patient with a prosthetic heart valve 5. History of congenital heart disease with any residual anatomic or conduction abnormality 6. History of abnormal bleeding and/or clotting disorder. 7. Active malignancy or history of treated cancer within 24 months of enrolment. 8. Clinically significant current infection or sepsis. 9. History of any cerebral ischemic events (stroke or TIA) or thromboembolic events or evidence of intracardiac thrombus at the time of the procedure. 10. New York heart Association (NYHA) function class IIIb or IV congestive heart failure and/or any heart failure hospitalisation within 3 months prior to enrolment. 11. Body mass index > 40 Kg/m2. 12. Estimate glomerular filtration rate (eGFR) < 35 mL/min/1.73 m2 or has ever received renal dialysis or transplant. 13. Any of the following within 3 months of enrolment: 13.1. Major surgery 13.2. Myocardial infarction or unstable angina 13.3. Any coronary intervention (e.g. Percutaneous coronary intervention) 13.4. Aborted sudden cardiac death. 13.5. Left atrial thrombus that has not resolved as shown by trans-oesophageal echocardiogram (TOE) or computerized tomography (CT) scan. 13.6. Implantation of permanent pacemaker implanted cardiac defibrillator, or cardiac resynchronisation therapy. 14. Solid organ or hematologic transplant, or currently being evaluated for an organ transplant. 15. History of pulmonary hypertension with Pulmonary systolic artery pressure >50 mm Hg, severe Chronic Obstructive Pulmonary Disease or restrictive lung disease. 16. Patients with any other significant uncontrolled or unstable medical condition (such as uncontrolled brady-arrhythmias, ventricular arrhythmias, hyperthyroidism or significant coagulopathy). 17. Patients with hemodynamically significant valvular disease, atrial or ventricular septal defect closure, pulmonary vein stenosis, atrial myxoma and/or significant or symptomatic hypotension. 18. Life expectancy less than one year. 19. Contraindication to anticoagulation (i.e., heparin, direct acting oral anticoagulation, Vitamin K Antagonist). 20. Hypertrophic cardiomyopathy 21. Patients who are unable to undergo brain MRI 22. Women who are currently pregnant or planning on becoming pregnant within six months of being on the study. 23. Patients who are unable to provide informed consent or unwilling or unable to comply fully with study procedures and follow-up. 24. Enrolled in another cardiac clinical study that would interfere with this study.
Outcome results
None listed