CLIP-IT Post-Market Study

Not Applicable

Active, not recruiting

• Conditions: Left Atrial Appendage Exclusion

• Registration Number: NCT06203054
• Lead Sponsor: Medtronic Cardiac Surgery

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.

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 at up to 25 sites in the United States.

Subjects will be followed at 30 days, 3 months, 12-months and annually for 36-months.

Study Timeline

• Study First Submitted: 2024-01-02
• Study First Submitted QC: 2024-01-02
• Study First Posted: 2024-01-12
• Study Start: 2024-02-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-20
• Primary Completion: 2025-11
• Study Completion: 2029-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• 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 Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Rate of successful exclusion of the left atrial appendage (LAA) from the heart	3 months post procedure	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.
Rate of device related adverse events	30 days post procedure	The primary safety endpoint is the composite rate of device related adverse events at 30-days post-procedure.

Secondary Outcome Measures

Name	Time	Method
Rate of successful placement of the Penditure™ left atrial appendage (LAA) Exclusion System	At the time of procedure	The secondary efficacy endpoint is defined as the rate of successful placement of the Penditure™ LAA Exclusion System defined as \< 10 mm of residual stump proximal to the clip at the time of the procedure (measured by intraoperative TEE with doppler) without tissue damage requiring intervention.
Rate of device related adverse events	At 1 year, 2 year, and 3 years post procedure	The secondary safety endpoint is defined as the composite device related adverse event rate at 12-months and annually through 36 months.

Trial Locations

Locations (15)

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; 🇺🇸 Saint 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

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