For more than three years, the cardiology team at Baylor Scott & White Heart and Vascular Hospital – Fort Worth has been an active enrollment site for the Amplatzer Amulet LAAO vs. NOAC clinical trial (CATALYST).
To refer a patient for enrollment in the CATALYST trial, contact 817.922.1398 or Kristina.Perez@BSWHealth.org.
“The objective of the trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to novel oral anticoagulant (NOAC) therapy in patients with non-valvular AFib at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy,” says Scott Ewing, DO, FACOI, FACC, principal investigator at the hospital for the trial and medical director of quality. “Between three and six million Americans are living with AFib, so it is a condition seen by cardiologists daily. Because AFib can cause blood clots to form, resulting in an increased risk of stroke, the treatment of choice has been anticoagulant medication (blood thinners).
However, some patients are not able to take blood thinners, or they have other health issues such as cancer, bone marrow problems, or conditions that make the patients candidates for a fall and the associated bleeding that might result. The occluder is approved for use with these patients. This trial is looking at the group of patients who can take NOAC therapy but who do not want to take blood thinners for some of the other health reasons I’ve already mentioned.”
What is an LAA occluder, and how does it work?
Current evidence suggests percutaneous occlusion of the left atrial appendage (LAA) reduces the risk of thromboembolic complications associated with non-valvular AFib. The Amplatzer Amulet LAA Occluder is designed for complete occlusion of the LAA, thereby reducing the risk for ischemic stroke caused by AFib.
“CATALYST trial participants will be randomized 1:1 to receive the Amplatzer Amulet LAA Occluder or NOAC therapy,” explains Aleem Mughal, MD, FHRS, medical director of electrophysiology at Baylor Scott & White Heart and Vascular Hospital – Fort Worth. “The Amulet occluder is introduced to the left atrium via a minimally invasive transcatheter approach through a femoral venous puncture. Using echocardiography and fluoroscopy, the Amulet occluder is guided to the left atrial appendage. Retention wires on the lobe secure the occluder, while the disc expands to seal the appendage orifice.”
Important clinical trial inclusion and exclusion criteria
When considering whether to refer a patient for enrollment in the CATALYST trial, here are important inclusion and exclusion criteria:
Inclusion criteria:
- A documented history of non-valvular atrial fibrillation
- CHA2DS2-VASc score greater than or equal to 2 for men and 3 for women
- Eligible for long-term NOAC therapy
Exclusion criteria:
- Patient requires long-term OAC therapy for a condition other than AF
- Planned cardiac intervention or surgery within three months following randomization
- Known contraindications to, or allergic to, aspirin, clopidogrel or OAC medication use
