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The objective of this pilot study is to confirm that endocardial ablation using the FARAPULSE Ablation System Plus with commercial design devices is both safe and effective for treating drug-resistant paroxysmal atrial fibrillation (PAF).
Full description
This is a prospective, multi-center, single arm safety and effectiveness pilot study. Subjects will undergo percutaneous PFA ablation for pulmonary vein isolation and at the clinical discretion of the investigator receive PFA ablation of additional arrhythmogenic locations. Subjects will be followed at 7 days (telephonic), 30 days, 90 days, 6 months and 12 months for adverse events, recurrence of arrhythmia after a 90-day Blanking Period and other relevant outcome measures.
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Inclusion and exclusion criteria
Inclusion Criteria:Study subjects are required to meet all the following inclusion criteria to participate in this study:
Patients with documented drug resistant symptomatic PAF
Patients who are ≥ 18 and ≤ 75 years of age on the day of enrollment.
Patient participation requirements:
Exclusion Criteria: Subjects will be excluded from participating in this study if they meet any one of the following exclusion criteria:
AF that is:
Left atrial anteroposterior diameter ≥ 5.0 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT)
Any of the following cardiac procedures, implants or conditions:
Any of the following cardiovascular procedures, implants, or conditions:
a. Within the 3 months preceding enrollment:
i. Myocardial infarction
ii. Unstable angina
iii. Percutaneous coronary intervention
iv. Treatment with amiodarone
b. Within the 6 months preceding enrollment:
i. Heart surgery
ii. Stroke or TIA
iii. Any thromboembolic event
iv. Carotid stenting or endarterectomy
v. Pericarditis or pericardial effusion
c. Within the 12 months following enrollment:
i. Any likelihood of cardiac surgery or transplant
History of blood clotting or bleeding abnormalities.
Contraindication to, or unwillingness to use, systemic anticoagulation
Contraindications to both CT and MRI
Sensitivity to contrast media not controlled by premedication
Women of childbearing potential who are pregnant, lactating, not using birth control or planning to become pregnant during the anticipated study period
Medical conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or confound data or its interpretation, including but not limited to
Clinically significant psychological condition that in the investigator's opinion would prohibit the subject's ability to meet the protocol requirements
Current or anticipated enrollment in any other clinical study
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15 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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