A Pivotal Investigational Device Exemption Study on Laminar Left Atrial Appendage Elimination

Launched by BIOSENSE WEBSTER, INC. · Dec 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the Laminar Left Atrial Appendage Closure (LAAC) device. The goal is to see how safe and effective this device is compared to existing LAAC devices for people with non-valvular atrial fibrillation (a heart condition that can increase the risk of strokes). The study is especially focused on reducing the risk of strokes and other serious blood vessel issues in participants who may be looking for alternatives to long-term blood-thinning medications.

To participate in this trial, volunteers need to be between the ages of 65 and 74 and have a specific type of atrial fibrillation that is documented. They should also have a certain score that indicates their risk for stroke and be recommended for the LAAC procedure by their doctor. Participants will need to agree to follow the study guidelines and provide written consent. Those who qualify can expect to receive care and monitoring throughout the study to track the device's performance and their health outcomes. It's an important opportunity for patients seeking innovative solutions for managing their condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Documented evidence of paroxysmal, persistent, or permanent non-valvular atrial fibrillation (NVAF)
• • CHA2DS2-VASc score greater than or equal to (\>=) 2 in men and \>= 3 in women
• • Deemed to be clinically indicated for left atrial appendage (LAA) closure by the Site Investigator and a clinician not a part of the procedural team using an evidence-based decision-making tool in accordance with standard of care
• • Recommended for chronic oral anticoagulation therapy (OAC) but has an appropriate rationale to seek a non-pharmacologic alternative
• • Eligible for the protocol-specified post-procedural antithrombotic regimen
• • Willing and able to comply with the protocol, and has provided written informed consent (participant or legally authorized representative) per institutional review board (IRB) requirements
• Exclusion Criteria:
• • Single episode, transient, or reversible atrial fibrillation (AF) (example, secondary to thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
• • Prior cardiac surgery or any procedure that involved pericardial access
• • Stage IV kidney disease or Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) less than (\<) 30 milliliters per minute per (mL/min)/1.73 square meters (m\^2) or participants with end stage renal disease who are dialysis dependent
• • Any cardiac or non-cardiac interventional or surgical procedures within 60 days prior to or any planned general surgery, cardiac surgery, or interventional procedure within 60 days after implant (including, but not limited to cardioversion, percutaneous coronary intervention (PCI), cardiac ablation, cataract surgery)
• • Left atrial appendage anatomy which cannot accommodate either commercially available control device or the laminar implant per manufacturer instructions for use (IFU) (that is, the anatomy and sizing must be appropriate for a control and the Laminar device to be enrolled in the study)