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New treatment option for Atrial Fibrillation (AF)
Official title Prospective Remapping With Concomitant Left Atrial Appendage Occlusion to Ensure Durable Electroporation Study
ClinicalTrials.gov ID: NCT07620262
What this study is testing
- What it's testing
- This is a single-arm, open label, clinical outcome study to research the durability (success) of receiving a pulsed field ablation (PFA) per standard of care for treatment of atrial fibrillation during a subsequent procedure for the insertion of a left atrial appendage occlusion (LAAO) device. The reassessment of the initial ablation will be performed with or without additional ablation if needed.
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
- Participant is ≥ 18 years of age, or older if specified by local law
- Participant has documented paroxysmal or persistent atrial fibrillation not related to a reversible cause
- Participant has AF-related symptoms, and/or presence of CHF or LV dysfunction
- Participant has a CHADSVASc\>=3 in women and \>=2 in men
- There is appropriate rationale to seek a non-pharmacologic alternative to long-term oral anticoagulation for thromboembolic protection
You likely can't join if
- Participant has had prior AF ablation (including surgical ablation)
- Participant has had prior left atrial appendage occlusion or closure
- Participant has an intracardiac mass or thrombus
- Participant has had a bleeding disorder or inability to tolerate short-term oral anticoagulation
- Participant has a life expectancy \< 1 year
- Participant has had recent MI, CVA, or cardiac surgery in preceding 90 days
See the full eligibility criteria
- Participant is ≥ 18 years of age, or older if specified by local law
- Participant has documented paroxysmal or persistent atrial fibrillation not related to a reversible cause
- Participant has AF-related symptoms, and/or presence of CHF or LV dysfunction
- Participant has a CHADSVASc\>=3 in women and \>=2 in men
- There is appropriate rationale to seek a non-pharmacologic alternative to long-term oral anticoagulation for thromboembolic protection
- Participant is willing and capable of providing informed consent
- Participant is willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center
- Participant has had prior AF ablation (including surgical ablation)
- Participant has had prior left atrial appendage occlusion or closure
- Participant has an intracardiac mass or thrombus
- Participant has had a bleeding disorder or inability to tolerate short-term oral anticoagulation
- Participant has a life expectancy \< 1 year
- Participant has had recent MI, CVA, or cardiac surgery in preceding 90 days
- Participant has an inability to comply with outpatient follow-up, or cognitive impairment that precludes understanding of procedure risks and benefits
- Participant has an active systemic infection
- Participant has a mechanical heart valve through which the catheter must pass, or severe mitral stenosis
- Participant has a vena cava embolic protection filter devices and/or known femoral thrombus who require catheter insertion from the femoral approach
- Participant had congenital heart disease where the underlying abnormality increases the risk of ablation (e.g. severe rotational anomalies of the heart or great vessels)
- Participant is woman of childbearing potential who is pregnant, lactating, not using a reliable form of contraception, or who is planning to become pregnant during the anticipated study period
- Participant has longstanding persistent AF ongoing for greater than 10 years
- Participant has Left atrial appendage anatomy unsuitable for LAAO device
- Participant has an LA diameter \>6 cm
The study team makes the final eligibility decision.
Where it's taking place
- Bay Shore, New York, United States
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 Bay Shore, New York, United States. 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.