A Safety and Feasibility Study of the FARAPULSE Endocardial Ablation System to Treat Paroxysmal Atrial Fibrillation
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|ClinicalTrials.gov Identifier: NCT03714178|
Recruitment Status : Completed
First Posted : October 22, 2018
Last Update Posted : February 18, 2021
|Condition or disease||Intervention/treatment||Phase|
|Paroxysmal Atrial Fibrillation||Device: FARAPULSE Endocardial Ablation System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Patients undergoing catheter ablation of paroxysmal atrial fibrillation and meeting all protocol inclusion/exclusion criteria will be treated with the FARAPULSE Endocardial Ablation System.|
|Masking:||None (Open Label)|
|Official Title:||PEFCAT: A Safety and Feasibility Study of the FARAPULSE Endocardial Ablation System to Treat Paroxysmal Atrial Fibrillation|
|Actual Study Start Date :||October 20, 2018|
|Actual Primary Completion Date :||December 21, 2020|
|Actual Study Completion Date :||December 21, 2020|
Experimental: FARAPULSE Endocardial Ablation
Subjects who are treated with the FARAPULSE Endocardial Ablation System for paroxysmal atrial fibrillation.
Device: FARAPULSE Endocardial Ablation System
Endocardial ablation using the FARAPULSE Endocardial Ablation System.
- The primary safety endpoint for this study is the Composite Safety Endpoint (CSE) defined as the incidence of early-onset and late-onset serious adverse events (SAEs) which are device- or procedure-related. [ Time Frame: 30 Days ]
Early onset (within 30 days of any endocardial ablation for atrial fibrillation). Occurrence of any one of the below events will qualify a subject as a safety failure.
- Myocardial infarction (MI)
- Persistent diaphragmatic paralysis
- Stroke or transient ischemic attack (TIA)
- Peripheral or organ thromboembolism
- Cardiac tamponade / perforation
- Vascular access complications
- Hospitalization (initial or prolonged)*
- Heart block Late onset (any time during follow-up)
- Pulmonary vein (PV) stenosis (> 70% diameter reduction from baseline)
- Atrio-esophageal fistula * Excludes hospitalization (initial & prolonged) solely due to arrhythmia (AF/Atrial Flutter/Atrial Tachycardia) recurrence or due to non-urgent cardioversion (pharmacological or electrical).
- Feasibility: Pulmonary Vein Isolation [ Time Frame: 1 Day (Acute) ]The proportion of subjects that achieve Acute Procedural Success (APS) defined as the percutaneous endocardial creation of a complete, electrically isolating set of lesions around the ostia of the pulmonary veins (PVI) using the FARAPULSE Endocardial Ablation System during the first procedure, as clinically assessed by entrance and/or exit block performed ≥ 20 minutes after the last PVI lesion is made.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03714178
|Nemocnice Na Homolce|
|Principal Investigator:||Petr Neuzil, MD, PhD||Nemocnice Na Homolce|