Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation - Europe, Middle East and Africa [OPTION-EMEA]
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 500
- Locations
- 2
- Primary Endpoint
- Primary Safety Endpoint (PSE): Device or Procedure Related Serious Adverse Events
Overview
Brief Summary
The OPTION-EMEA post-market study is intended to gather real world clinical data for patients undergoing AF ablation with the FARAPULSE™ Pulsed Field Ablation (PFA) System and subsequent left atrial appendage closure (LAAC) with a WATCHMAN FLX™ Pro or WATCHMAN FLX device during one interventional case.
The study will include patients that are clinically indicated for atrial fibrillation (AF) ablation using the FARAPULSE PFA System and for left atrial appendage closure (LAAC) treatment using a WATCHMAN FLX Pro or WATCHMAN FLX device as part of the patient's standard of care determined by their doctor's medical judgement.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinically indicated for treatment with both the FARAPULSE™ PFA system and with WATCHMAN FLX™ Pro or WATCHMAN FLX™ for LAAC, per physician medical judgement and as per hospitals' standard of care.
- •Subjects who are willing and able to provide informed consent.
- •Subjects who are willing and able to participate in all testing associated with this clinical study at an approved investigational center.
- •Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.
Exclusion Criteria
- •Subjects who underwent prior AF ablation procedure.
- •Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes.
- •Already surgically closed or otherwise excluded LAA.
- •The LAA anatomy does not accommodate a Closure Device.
- •Known or suspected atrial myxoma.
- •Presence of intracardiac thrombus\*.
- •Subjects with a current interatrial baffle or patch, history of atrial septal repair or has an atrial septal defect (ASD) / patent foramen ovale (PFO) device.
- •Subjects with a presence of a mechanical valve prosthesis in any position.
- •Subjects with a myocardial infarction within 90 days prior to enrollment.
- •Subjects had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within 90 days prior to enrollment.
Arms & Interventions
Single arm study
Subjects who meet eligibility criteria will undergo AF ablation and left atrial appendage closure using the FARAPULSE PFA system and WATCHMAN FLX Pro or WATCHMAN FLX during one interventional case.
Intervention: Concomitant Pulsed Field Ablation and Left Atrial Appendage Closure (Procedure)
Single arm study
Subjects who meet eligibility criteria will undergo AF ablation and left atrial appendage closure using the FARAPULSE PFA system and WATCHMAN FLX Pro or WATCHMAN FLX during one interventional case.
Intervention: Concomitant pulsed field ablation (PFA) and left atrial appendage closure (LAAC) during one interventional case (Device)
Outcomes
Primary Outcomes
Primary Safety Endpoint (PSE): Device or Procedure Related Serious Adverse Events
Time Frame: 30 days following the index procedure.
The PSE is the proportion of subjects who experience one or more device- or procedure-related composite serious adverse events (CSAEs) assessed at 30 days following the index procedure.
Primary Efficacy Endpoint (PEE): Acute Treatment Success
Time Frame: Through 30 days
The PEE is the proportion of subjects with Acute Treatment Success assessed among those receiving ≥ 1 PFA application and who have WATCHMAN device deployment attempted or successfully implanted.
Secondary Outcomes
No secondary outcomes reported