CLIP-IT Post-Market Study
exClusion of the Left atrIal Appendage With PendITure™ (CLIP-IT) Post-Market Study
1 other identifier
interventional
198
1 country
15
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 concomitant cardiac surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2024
Longer than P75 for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 2, 2024
CompletedFirst Posted
Study publicly available on registry
January 12, 2024
CompletedStudy Start
First participant enrolled
February 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 26, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2029
ExpectedMay 1, 2026
April 1, 2026
1.5 years
January 2, 2024
April 27, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Rate of successful exclusion of the left atrial appendage (LAA) from the heart
The primary efficacy endpoint is the rate of successful exclusion of the left atrial appendage (LAA) from the heart defined as the absence of residual communication (≤ 3 mm residual contrast communication) between the left atrium (LA) and the left atrial appendage (LAA). For those successfully placed devices, exclusion will be confirmed at 3 months as demonstrated by multi-detector computed tomography (MDCT) scan.
3 months post procedure
Rate of device related adverse events
The primary safety endpoint is the composite rate of device-related serious adverse cardiac events at 30-days post-procedure.
30 days post procedure
Secondary Outcomes (2)
Rate of successful placement of the Penditure™ left atrial appendage (LAA) Exclusion System
At the time of procedure
Rate of device related adverse events
At 1 year, 2 year, and 3 years post procedure
Study Arms (1)
Penditure™ Left Atrial Appendage (LAA) Exclusion System
EXPERIMENTALPenditure™ Left Atrial Appendage (LAA) Exclusion System
Interventions
Exclusion of the left atrial appendage using the Penditure™ Left Atrial Appendage (LAA) Exclusion System in subjects undergoing concomitant cardiac surgery.
Eligibility Criteria
You may qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Ascension St. Vincent Heart Center
Carmel, Indiana, 46290, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Corewell Health
Grand Rapids, Michigan, 49503, United States
Mayo Clinic Saint Marys Campus
Rochester, Minnesota, 55905, United States
Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
Saint Joseph's Hospital Health Center
Syracuse, New York, 13203, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
ProMedica Toledo Hospital
Toledo, Ohio, 43606, United States
UPMC Pinnacle Harrisburg Campus
Harrisburg, Pennsylvania, 17101, United States
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213, United States
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, 19096, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Swedish Medical Center Cherry Hill
Seattle, Washington, 98112, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2024
First Posted
January 12, 2024
Study Start
February 26, 2024
Primary Completion
August 26, 2025
Study Completion (Estimated)
February 1, 2029
Last Updated
May 1, 2026
Record last verified: 2026-04