AMAZE

Left Atrial Appendage Ligation with The Lariat™ Suture Delivery System As Adjunctive Therapy to Pulmonary Vein Isolation For Persistent or Longstanding Persistent Atrial Fibrillation

Objective

To demonstrate the ability of the LARIAT+® Suture Delivery System to: (1) percutaneously isolate and ligate the Left Atrial Appendage (LAA) from the left atrium (LA) as an adjunct to planned pulmonary vein isolation (PVI) catheter ablation in the treatment of subjects with symptomatic persistent or longstanding persistent atrial fibrillation (AF); (2) demonstrate that the adjunctive percutaneous LAA ligation procedure does not result in an unacceptable risk of serious adverse events (SAEs) in persistent or longstanding persistent AF subjects for whom a catheter ablation procedure is planned; and (3) assess freedom from episodes of AF > 30 seconds duration any time following the 90-day blanking period post-index PVI through 12 months post PVI.

Eligibility

  • Documented diagnosis of symptomatic continuous persistent or longstanding persistent non-valvular atrial fibrillation
  • Failed at least one Class I or III Antiarrythmic drug (AAD) and therefore, eligible and intended for standard of care catheter ablation
  • Life expectancy ≥ 1 year
  • Willing and able to return to and comply with scheduled follow-up visits and tests

NCT ID

NCT02513797