CLIP-IT Post Market Study: Exclusion of the Left Atrial Appendage With Penditure™

Overview

About this study

The purpose of this study is to test the rate of successful exclusion of the  left atrIal appendage (LAA) from the heart defined as the absence of residual communication (≤ 3 mm residual jet velocity communication) between the left atrium (LA) and the LAA. For those successfully placed devices, exclusion will be confirmed at 3 months as demonstrated by multi-detector computed tomography (MDCT) scan.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Juan Crestanello, M.D.

Open for enrollment

Contact information:

Cori Larson CCRP

(507) 255-0036

Larson.Cori@mayo.edu

More information

Publications

Publications are currently not available