Lifetech LAmbre™ Left Atrial Appendage (LAA) Closure System Post-Market Clinical Follow-up Study

Korábbi kezelés

• Currently participating in other investigational drug- or device studies;

Más betegség

• Any contra-indication mentioned in the corresponding IFU*;
  • Note: In IFU, the Left Atrial Appendage Closure System is contraindicated for the following:
  • Patients' LAA anatomy is not suitable for the REF of the device.
  • Patients with intracardiac thrombus.
  • Patients with active endocarditis or other infections causing bacteremia.
  • Patients where the placement of the device would interfere with any intracardiac or intravascular structures.
  • Patients with contraindications to X-ray and/or trans-esophageal echocardiographic examinations.
  • Patients with known hypersensitivity to nickel.

Egyéb

• Patient who is pregnant, planning to become pregnant or breastfeeding;
• Patients cannot tolerate transoesophageal echocardiogram (TEE).

• Patients must be at least 18 years of age;
• Patients with non-valvular paroxysmal, persistent, or permanent atrial fibrillation with long-term sustainability scheduled for interventional LAA closure;
• Patient characteristics consistent with the corresponding IFU and sizing guidelines*;
  • Note: Choose a device that is 3-8mm larger than the landing zone diameter.
• The patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the appropriate Ethics Committee (EC);
• The patient agrees to comply with the requirements of the study including the 3-year follow-up.
  • Warning: The device sizing is based on angiographic measurements.