None listed
Conditions
Brief summary
The objective of this study is to provide supporting clinical evidence in particular with regard to the efficacy and safety of the ElePulse electroporation ablation system. It might reveal indicators for hidden risks and trigger further dedicated investigations or tests.
Interventions
Catheter ablation is an atrial fibrillation treatment that is done by a specialized cardiologist, called an electrophysiologist (EP), who deals with irregular heartbeats (arrhythmias). It is a minimally-invasive procedure that is generally less invasive than surgery. It is a commonly-used treatment for atrial fibrillation as well as other cardiac arrhythmias. It is done on a beating heart in a closed chest procedure. Small punctures are made in the groin and the catheters, are inserted and threaded to the heart. Once there, the catheter's tip is threaded through a tiny incision in the wall between the left and right atria (septal wall), and is positioned to ablate tissue around the pulmonary veins or at other sources of erratic electrical signals that cause the irregular heartbeat. The catheter uses an energy source, such as radio frequency energy (radio waves) to create a lesion of scar tissue, called a conduction block, that stops the erratic electrical signals from travelling through the heart. The procedure usually takes around 2 to 4 hours per patient. The ElePulse system which is used in this study is an electroporation ablation system. It uses pulsed field energy to selectively destroy cardiac tissue and thus stop aberrant electric conduction in the heart. This is called Pulsed Field Ablation (PFA). The ElePulse catheter is connected to the ElePulse PFA generator which creates the electric field used to ablate the heart tissue. A remap procedure will be performed at 3 months after the completion of the ablation procedure. During this procedure it will be determined whether the success of the first procedure was durable. The remap procedure is comparable in duration to the initial procedure. If the first procedure is not considered adequate, a re-ablation may be performed during the remap procedure.
Sponsors
Study design
Eligibility
Inclusion criteria
Suitable candidate for intra-cardiac mapping and ablation for arrhythmias History of recurrent symptomatic paroxysmal atrial fibrillation (AF) At least one episode of AF documented by Holter monitor, rhythm strip, trans-telephonic monitor (TTM), or 12-lead ECG prior to enrollment Refractory to at least one Class I - IV anti-arrhythmic drug (AAD) Competent and willing to provide written informed consent to participate in the study and agree to comply with the follow-up visits and evaluation.
Exclusion criteria
Previous left atrial ablation procedure Intracardiac thrombus, tumor or other abnormality that precludes catheter introduction and placement Known severe cerebrovascular disease or history of cerebrovascular event (within 1 month) Patients with severely impaired kidney function Active gastrointestinal bleeding Active infection or fever Sepsis Cardiac surgery within the past two months Short life expectancy (< 1yr) due to other illnesses, such as cancer or pulmonary, hepatic, or renal disease Significant anemia Severe uncontrolled systemic hypertension (systolic press. > 240 mm Hg within the last 30 days) Documented anaphylaxis during previous exposure to angiographic contrast media