Status:
ACTIVE_NOT_RECRUITING
CLIP-IT Post-Market Study
Lead Sponsor:
Medtronic Cardiac Surgery
Conditions:
Left Atrial Appendage Exclusion
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 concomi...
Detailed Description
Multi center, single-arm, nonrandomized, interventional, unblinded, post-market study. Up to 150 subjects will be enrolled and implanted with the Penditure™ Left Atrial Appendage (LAA) Exclusion Clip ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
February 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2029
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06203054
Start Date
February 26 2024
End Date
February 1 2029
Last Update
October 28 2025
Active Locations (15)
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1
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342
2
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
3
Ascension St. Vincent Heart Center
Carmel, Indiana, United States, 46290
4
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109