Clinical Trials

Inclusion Criteria:

* Patient is indicated to be treated with the Penditure? LAA Exclusion System
* Greater than or equal to 18 years of age
* The subject is willing and able to provide written informed consent and comply with study visit requirements

Exclusion Criteria:

* Prior LAA isolation attempt(s)
* Need for emergent cardiac surgery
* Subject is contraindicated for MDCT and/or TEE
* Life expectancy of less than 12 months
* History of cardiac surgery
* Pericarditis
* Presence of thrombus in the left atrium or LAA, prior to or during the procedure
* Patients requiring a heart transplant, insertion of a ventricular assist device or total artificial heart, and/or ascending aortic aneurysm or dissection repair requiring circulatory arrest
* STS-PROM score greater than 4 or subject deemed to be high or extreme risk per surgeon assessment
* Ejection fraction less than 30%
* Chronic Kidney Disease Stage IV or V (eGFR \<30 ml/min)
* NYHA Class IV heart failure symptoms
* Patient has a documented history of substance (drug or alcohol) abuse
* Known allergy to device components (Nickel and/or Titanium)
* In the opinion of the investigator, the subject is not a suitable candidate for LAA isolation due to risks outweighing potential benefits including, complexity of planned concomitant procedures, or other pre-existing medical conditions
* Currently participating in an investigational drug or another device trial or study (excluding registries)

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 07/22/2024. Questions regarding updates should be directed to the study team contact.