CLIP-IT Post-Market Study

Running, not enrolling · Not applicable

Conditions studied: Left Atrial Appendage Exclusion

In brief

The purpose of this study is to collect post-market clinical evidence on performance and clinical outcomes of the Penditure™ Left Atrial Appendage (LAA) Exclusion System in subjects undergoing concomitant cardiac surgery.

Key facts

Study ID

NCT06203054

Run by

Medtronic Cardiac Surgery

People needed

198

Starts

2024-02-26

Expected to finish

2029-02-01

Last updated by the study team

2026-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is indicated to be treated with the Penditure™ left atrial appendage (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

You may not qualify if…

• Prior left atrial appendage (LAA) isolation attempt(s)
• Need for emergent cardiac surgery
• Subject is contraindicated for multi-detector computed tomography (MDCT) and/or transesophageal echocardiogram (TEE)
• Life expectancy of less than 12 months
• History of cardiac surgery
• Pericarditis
• Presence of thrombus in the left atrium or left atrial appendage (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
• Society of Thoracic Surgeons Predicted Risk of Mortality (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 (estimated glomerular filtration rate (eGFR) <30 ml/min)
• New York Heart Association (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)

Where it is running

• Emory Saint Joseph's Hospital — Atlanta, Georgia, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Ascension St. Vincent Heart Center — Carmel, Indiana, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Corewell Health — Grand Rapids, Michigan, United States
• Mayo Clinic Saint Marys Campus — Rochester, Minnesota, United States
• Barnes Jewish Hospital — St Louis, Missouri, United States
• Saint Joseph's Hospital Health Center — Syracuse, New York, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• ProMedica Toledo Hospital — Toledo, Ohio, United States
• UPMC Pinnacle Harrisburg Campus — Harrisburg, Pennsylvania, United States
• University of Pittsburgh Medical Center UPMC Presbyterian — Pittsburgh, Pennsylvania, United States
• Lankenau Institute for Medical Research — Wynnewood, Pennsylvania, United States
• Houston Methodist Hospital — Houston, Texas, United States
• Swedish Medical Center Cherry Hill — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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