CLIP-IT Post-Market Study

exClusion of the Left atrIal Appendage With PendITure™ (CLIP-IT) Post-Market Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Left Atrial Appendage Exclusion
• Intervention / Treatment: Device: Penditure™ Left Atrial Appendage (LAA) Exclusion System

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 Type: Interventional
• Enrollment (Actual): 198
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Emory Saint Joseph's Hospital
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
  • Indiana
    • Carmel, Indiana, United States, 46290
      • Ascension St. Vincent Heart Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System
    • Grand Rapids, Michigan, United States, 49503
      • Corewell Health
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Saint Marys Campus
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Barnes Jewish Hospital
  • New York
    • Syracuse, New York, United States, 13203
      • Saint Joseph's Hospital Health Center
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
    • Toledo, Ohio, United States, 43606
      • ProMedica Toledo Hospital
  • Pennsylvania
    • Harrisburg, Pennsylvania, United States, 17101
      • UPMC Pinnacle Harrisburg Campus
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center UPMC Presbyterian
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Institute for Medical Research
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
  • Washington
    • Seattle, Washington, United States, 98112
      • Swedish Medical Center Cherry Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Penditure™ Left Atrial Appendage (LAA) Exclusion System	Device: Penditure™ Left Atrial Appendage (LAA) Exclusion System; Exclusion of the left atrial appendage using the Penditure™ Left Atrial Appendage (LAA) Exclusion System in subjects undergoing concomitant cardiac surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of successful placement of the Penditure™ left atrial appendage (LAA) Exclusion System	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.	At the time of procedure
Rate of device related adverse events	The secondary safety endpoint is defined as the composite device-related serious adverse cardiac event rate at 12-months and annually through 36 months.	At 1 year, 2 year, and 3 years post procedure

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Surgery

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2024
• Primary Completion (Actual): August 26, 2025
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: January 2, 2024
• First Submitted That Met QC Criteria: January 2, 2024
• First Posted (Actual): January 12, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: MDT22049

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No