NCT06765356

Pragmatic Evaluation of a Pentaspline Pulsed Field Ablation System to Treat Atrial Fibrillation and Related Arrhythmias

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 275 (actual)
• Sponsor: Vivek Reddy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

By virtue of its efficiency, safety profile, and potential for improved efficacy, there is tremendous excitement about the role of pulsed field ablation (PFA) to treat atrial fibrillation. Indeed, multiple FDA IDE clinical trials on PFA have been, or are being, conducted to treat AF. However, most FDA pivotal trials studying PFA enroll very selected populations and have highly focused inclusion/exclusion criteria and, typically only paroxysmal or persistent AF patients with limited upper age criteria are included, failure of Class I/III AADs is often required, and other disease states that may particularly benefit from PFA (e.g., PFA might be particularly effective in treating HCM pts with their thickened atrial tissue). In observational European studies of the FARAPULSE catheter system, the technology has proved quite safe and effective in treating most patients with AF. It is a highly efficient ablation system, and can be employed with only deep sedation, and without the need for endotracheal intubation. In addition to the FARAWAVE catheter performing PV isolation and ablation of the posterior left atrium, in the MANIFEST-PF post-approval study of EU experience, the FARAWAVE catheter has also been shown able to create other relevant ablation lesions such as cavo-tricuspid isthmus ablation for typical atrial flutter, or a mitral isthmus line for mitral isthmus flutter. The FARAWAVE multielectrode pentaspline PFA catheter is the study device. It can be deployed in a basket or flower configuration: 1) Both configurations can be used to isolate PVs, 2) The flower configuration can be used to ablate the posterior wall, and 3) Flower configuration for creation of CTI or Mitral Isthmus Lines. The ablation procedure will typically follow the below sequence: * Pulmonary Vein Isolation (PVI) to be achieved in all patients with atrial fibrillation * Posterior wall Ablation: will be used in all persistent/LS-Per AF patients, and as per operator discretion, some paroxysmal AF patients * Additional ablation lesion sets are per investigators' discretion: * Cavo-tricuspid isthmus line * Mitral Isthmus Line * Regional fractionation clusters (allowed but not encouraged) * Any micro-/macro-reentrant atrial tachycardia's * When PFA is performed next to a coronary artery (eg, CTI or mitral isthmus lines), a nitroglycerin pretreatment protocol will be employed as per study protocol. * As part of the ablation procedure, any safety assessments that are considered important (e.g., EGD, coronary angiography, etc.) may be performed as per the investigators' discretion; these data will also be collected. * For a lesion set that cannot be performed using the FARAPULSE catheter technology, a conventional FDA-approved ablation catheter may be used to complete the procedure as per whatever is optimal for the patient outcome This study is a prospective, multi-center, non-randomized, investigator-initiated IDE clinical study to determine the safety and efficacy of the recently FDA-approved FARAPULSE system to treat the "usual" patients presenting in clinical practice for catheter ablation of AF. (An IDE is required because the approval for the FARAPULSE system: i) only includes paroxysmal AF patients, and ii) doesn't include the technology's use for linear lesions such as the cavo-tricuspid isthmus line. Participants will be followed for 12-months post-procedure. There is an optional randomized sub-study looking at the utility of peri-procedural low-dose colchicine in attenuating PFA-related pericardial inflammation and its negative effects (symptoms and atrial arrhythmias). Participants will start low-dose colchicine 5 days prior to PFA procedure and continue up to 3 weeks post-PFA treatment.

Conditions

• Persistent Atrial Fibrillation
• Paroxysmal Atrial Fibrillation
• Long-standing Persistent Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Farapulse Catheter System	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.
DRUG	Low-dose Colchicine	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.

Timeline

• Start date: 2025-04-15
• Primary completion: 2027-03-30
• Completion: 2027-03-30
• First posted: 2025-01-09
• Last updated: 2026-04-14

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study