Device study for patients with longstanding, persistent atrial fibrillation

Study ID: aMAZE

aMAZE Study: LAA ligation adjunctive to PVI for persistent or longstanding persistent atrial fibrillation

This study is for patients who have been diagnosed with longstanding persistent atrial fibrillation, which puts them at a higher risk for stroke. Surgical ligation of the left atrial appendage (LAA) has been the focal point of stroke prevention in recent years. The LARIAT® Suture Delivery Device is the only FDA-approved product for this procedure.

This study is to evaluate the safety and effectiveness of the LARIAT system when used in conjunction with pulmonary vein isolation (PVI) catheter ablation.

*This trial is being conducted by Sheetal Chandhok, MD, and Glenn Harper, MD, of Bryn Mawr Medical Specialists. Both physicians are on the medical staff of Bryn Mawr Hospital and participating members of Lankenau Heart Institute.

This FDA-approved multicenter, prospective, randomized controlled trial is evaluating the safety and effectiveness of the LARIAT® device for percutaneous isolation and ligation of the LAA as an adjunct to planned PVI catheter ablation for treatment of persistent or longstanding persistent atrial fibrillation.

This study is being conducted in two stages:

  • Limited Early Stage (Stage 1): up to 250 subjects at up to 65 sites. (COMPLETED, transitioned to Stage 2)
  • Pivotal Stage/Phase III (Stage 2): up to 600 subjects at up to 65 sites. (ENROLLING) All subjects from both stages will be included in the primary analysis

*This trial is being conducted by Sheetal Chandhok, MD, and Glenn Harper, MD, of Bryn Mawr Medical Specialists. Both physicians are on the medical staff of Bryn Mawr Hospital and participating members of Lankenau Heart Institute.

Inclusion Snapshot

Must have been diagnosed with longstanding persistent atrial fibrillation

Contact Information

Lankenau Institute for Medical Research trial

Physician Investigator(s)

Study Locations