Pragmatic Evaluation of a Pentaspline Pulsed Field Ablation System to Treat Atrial Fibrillation and Related Arrhythmias
Vivek Reddy
275 participants
Apr 15, 2025
INTERVENTIONAL
Conditions
Summary
The purpose of this pragmatic study is to evaluate the safety, performance and effectiveness of the FARAPULSE catheter system (FARAWAVE catheter used in combination with the FARASTAR generator), to treat patients with atrial fibrillation during clinically-indicated ablation procedures
Eligibility
Inclusion Criteria14
- Age 18 or older
- Diagnosed with atrial fibrillation with or without concomitant atrial flutter by ECG at some point in the past, and by any criteria (ECG or clear symptoms within the past year)
- Previous catheter ablation for other arrhythmias (including left-sided ablation, but not for AF) is allowed
- Planned for a clinically-indicated catheter ablation procedure for managing paroxysmal or persistent atrial fibrillation in accordance with the following recommendations in the ACC/AHA/ACCP/HRS guidelines
- In patients with symptomatic AF in whom antiarrhythmic drugs have been ineffective, contraindicated, not tolerated or not preferred, and continued rhythm control is desired, catheter ablation is useful to improve symptoms.(Class 1)
- In selected patients (generally younger with few comorbidities) with symptomatic paroxysmal AF in whom rhythm control is desired, catheter ablation is useful as first-line therapy to improve symptoms and reduce progression to persistent AF. (Class 1)
- In patients (other than younger with few comorbidities) with symptomatic paroxysmal or persistent AF who are being managed with a rhythm-control strategy, catheter ablation as first-line therapy can be useful to improve symptoms. (Class 2a)
- In selected patients with asymptomatic or minimally symptomatic AF, catheter ablation may be useful for reducing progression of AF and its associated complications. (Class 2b)
- In patients who present with a new diagnosis of HFrEF and AF, arrhythmia-induced cardiomyopathy should be suspected, and an early and aggressive approach to AF rhythm control is recommended. (Class 1)
- In appropriate patients with AF and HFrEF who are on GDMT, and with reasonable expectation of procedural benefit, catheter ablation is beneficial to improve symptoms, QOL, ventricular function, and cardiovascular outcomes. (Class 1)
- In appropriate patients with symptomatic AF and HFpEF with reasonable expectation of benefit, catheter ablation can be useful to improve symptoms and improve QOL. (Class 2a)
- In athletes who develop AF, catheter ablation with PVI is a reasonable strategy for rhythm control because of its effectiveness and low risk of detrimental effect on exercise capacity. (Class 2a)
- Have in place or have plans for implantation of a loop recorder, pacemaker or cardiac defibrillator capable of recording atrial rhythm (e.g. dual chamber) (ideally, this implantable device would be present for at least 4 weeks pre-PFA)
- Able and willing to provide written consent and comply with all testing and follow-up requirements
Exclusion Criteria10
- Documented "active" left atrial thrombus (patients may later undergo the procedure if this is no longer present, eg, with anticoagulation treatment)
- Reversible cause of AF (e.g., post-operative, thyroid disorder, etc.)
- Conditions that make an AF ablation procedure unlikely to be successful (e.g., advanced infiltrative cardiomyopathies like amyloid, severe mitral stenosis or regurgitation, and cor pulmonale)
- PCI/STEMI within the prior 1 month
- Active systemic infection or sepsis
- Contraindication to all anticoagulation
- Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude an ablation procedure
- Women who are pregnant, lactating, or who are of childbearing age and plan on becoming pregnant during this trial.
- Life expectancy or other disease processes likely to limit survival to less than 12 months
- Currently, enrolled in an investigational study evaluating another device, biologic, or drug, that would interfere with this trial.
Interventions
The FARAWAVE PFA Catheter is a sterile, single use, over-the-wire, non-deflectable device that is used with the FARASTAR Catheter Connection Cable and FARASTAR Generator to enable delivery of Pulsed Field Ablation energy for irreversible electroporation. The FARAWAVE PFA Catheter has five (5) variably deployable splines. The five splines are undeployed during insertion and removal and during use can deploy continuously from an undeployed state through a partially deployed ("basket-shaped") configuration to a fully deployed ("flower-shaped") configuration with five petals.
For participants in the colchicine sub-study, 0.3 mg BID Colchicine. Colchicine will be prescribed to the patient starting 5 days prior to ablation. Patient will continue the colchicine for 3 weeks post-ablation.
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06765356