se of electroporation for cardiac ablation in patients with atrial fibrillatio

Not Applicable

Active, not recruiting

• Conditions: Atrial tachyarrhythmia; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12622001523796
• Lead Sponsor: BIOTRONIK Australia Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-08
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Freedom from recurrent AF will be assessed at 6 and 12 months via Holter monitoring[ At 12 months post procedure];Ablation system-related serious adverse events (SAEs) for instance atrial-esophageal fistula, cardiac tamponade/perforation, bleeding, death, phrenic nerve injury etc. assessed by clinical evaluation[ Any adverse events that occur within the first 7 days after the procedure];Procedure (but not system) related SAEs for example gastric motility disorder, myocardial infarction, pericarditis, pulmonary vein stenosis, stroke or transient ischemic attack assessed by clinical examination, patient reports of their symptoms[ Any adverse events that occur within the first 30 days post procedure]

Secondary Outcome Measures

Name	Time	Method
The chronic safety of the ElePulse system will be assessed by evaluating the nature and frequency of adverse events (AE) for example gastric motility disorder, myocardial infarction, pericarditis, pulmonary vein stenosis, stroke or transient ischemic attack assessed by clinical examination, patient reports of their symptoms. [ At 30 days, 3 months, 6 months and 12 months post-procedure];The chronic safety of the ElePulse system will be assessed by evaluating the nature and frequency of adverse device effects (ADE) for instance atrial-esophageal fistula, cardiac tamponade/perforation, bleeding, death, phrenic nerve injury etc. assessed by clinical evaluation[ At 30 days, 3 months, 6 months and 12 months post-procedure]