Clinical trial for Atrial Fibrillation (AF)
Official title OPTION-EMEA Clinical Trial
ClinicalTrials.gov ID: NCT07349121
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Clinically indicated for treatment with both the FARAPULSE™ PFA system and with WATCHMAN FLX™ Pro or WATCHMAN FLX™ for LAAC, per physician medical...
- people who are willing and able to provide informed consent.
- people who are willing and able to participate in all testing associated with this clinical study at an approved investigational center.
- people whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.
You likely can't join if
- people who underwent prior AF ablation procedure.
- people 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\ .
See the full eligibility 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.
- people who are willing and able to provide informed consent.
- people who are willing and able to participate in all testing associated with this clinical study at an approved investigational center.
- people whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.
- people who underwent prior AF ablation procedure.
- people 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\ .
- people with a current interatrial baffle or patch, history of atrial septal repair or has an atrial septal defect (ASD) / patent foramen ovale (PFO) device.
- people with a presence of a mechanical valve prosthesis in any position.
- people with a myocardial infarction within 90 days prior to enrollment.
- people had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within 90 days prior to enrollment.
- Any planned electrical cardioversion within 30 days following LAAC device implant.
- people with a known inability to obtain vascular access.
- people with any contraindication to percutaneous catheterization procedure (e.g., patient size does not accommodate required catheters, ventriculotomy or atriotomy) or congenital abnormalities (severe rotational...
- people with any active conditions (e.g. infection, bleeding disorder, unstable angina).
- people with any contraindications to short term use of anticoagulation therapy for conditions different from atrial fibrillation.
- people who are pregnant or planning to be pregnant.
- people with a life expectancy of ≤ 1 year per investigator's opinion.
- people who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a...
The study team makes the final eligibility decision.
Where it's taking place
- Aalst, Belgium
- Zagreb, Croatia
- Toulouse, France
- San Donato Milanese, Italy
- Salamanca, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aalst, Belgium; Zagreb, Croatia; Toulouse, France; San Donato Milanese, Italy; Salamanca, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.