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New treatment option for Non-valvular Atrial Fibrillation (NVAF)
Official title FIM Study of the LAmbre™ II LAA Occluder in Non-Valvular AF Patients
ClinicalTrials.gov ID: NCT07385599
What this study is testing
- What it's testing
- To evaluate the preliminary safety and feasibility of the LAmbreTM II Left Atrial Appendage Occluder and the Occluder Delivery System in patients with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism.
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
- The patient age ≥18 years;
- The patient has documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation;
- The patient has a CHA2DS2-VASc score of ≥ 2 in men and CHA2DS2-VASc score of ≥ 3 in women;
- The patient is recommended for oral anticoagulation therapy, but there is an appropriate rationale for seeking a non-pharmacologic alternative to...
- The patient is deemed suitable for LAA closure by the site investigator and a clinician not a part of the procedural team in the shared...
You likely can't join if
- Pregnant or nursing patients and those who plan pregnancy during the study period. Female patients of childbearing potential must have a negative...
- Patients with atrial fibrillation that is defined by a single occurrence, or that is transient or reversible (e.g., secondary to CABG, an treatment...
- Patients who require long-term anticoagulation for a condition other than atrial fibrillation;
- Bleeding diathesis or coagulopathy;
- Patients with rheumatic mitral valve disease, known severe mitral stenosis requiring surgical or percutaneous valve replacement, or existing...
- Active infection with bacteremia;
See the full eligibility criteria
- The patient age ≥18 years;
- The patient has documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation;
- The patient has a CHA2DS2-VASc score of ≥ 2 in men and CHA2DS2-VASc score of ≥ 3 in women;
- The patient is recommended for oral anticoagulation therapy, but there is an appropriate rationale for seeking a non-pharmacologic alternative to oral anticoagulation;
- The patient is deemed suitable for LAA closure by the site investigator and a clinician not a part of the procedural team in the shared decision-making process, and this determination has been documented in the...
- The patient is willing and able to comply with the required medication post-procedure and follow-up evaluations;
- The patient (or his or her legally authorized representative) has been informed of the nature of the study, agrees to its provisions, and has been provided written informed consent approved by the appropriate...
- Pregnant or nursing patients and those who plan pregnancy during the study period. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to the index...
- Patients with atrial fibrillation that is defined by a single occurrence, or that is transient or reversible (e.g., secondary to CABG, an treatment procedure, pneumonia, or hyperthyroidism);
- Patients who require long-term anticoagulation for a condition other than atrial fibrillation;
- Bleeding diathesis or coagulopathy;
- Patients with rheumatic mitral valve disease, known severe mitral stenosis requiring surgical or percutaneous valve replacement, or existing mechanical valve prosthesis;
- Active infection with bacteremia;
- Known hypersensitivity or contraindication to aspirin, clopidogrel, heparin, any device material or component (nickel titanium, PET, polypropylene), and/or contrast sensitivity;
- Prior atrial septal defect (ASD) or patient foramen ovale (PFO) surgical repair or implantation of closure device;
- Left atrial appendage is obliterated and surgical ligated;
- Underwent any cardiac or non-cardiac treatment or surgical procedure within 30 days prior to the procedure or planned to have the treatment or surgical procedure within 60 days after implant procedure (e.g...
- Recent (within 90 days prior to procedure) stroke, transient ischemic attack, or myocardial infarction;
- New York Heart Association Class IV;
- Patients with severe renal failure (estimated glomerular filtration rate\<30 ml/min/1.73m2);
- Known asymptomatic carotid artery disease with\>70% diameter stenosis OR symptomatic carotid disease (\>50% diameter stenosis with ipsilateral stroke or TIA). people with prior carotid endarterectomy or carotid stent...
- Life expectancy is less than 1 year;
- Current participation in another investigational drug or device study.
The study team makes the final eligibility decision.
Where it's taking place
- Shatin, Hong Kong
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 Shatin, Hong Kong. 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.