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NCT Number: NCT06203054

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Left Atrial Appendage Exclusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory Saint Joseph's Hospital, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Penditure™ Left Atrial Appendage (LAA) Exclusion System

Device

Exclusion of the left atrial appendage using the Penditure™ Left Atrial Appendage (LAA) Exclusion System in subjects undergoing concomitant cardiac surgery.

Primary outcomes

  1. Rate of successful exclusion of the left atrial appendage (LAA) from the heart

    Time frame: 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.

  2. Rate of device related adverse events

    Time frame: 30 days post procedure

    The primary safety endpoint is the composite rate of device-related serious adverse cardiac events at 30-days post-procedure.

Secondary outcomes

  1. Rate of successful placement of the Penditure™ left atrial appendage (LAA) Exclusion System

    Time frame: 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.

  2. Rate of device related adverse events

    Time frame: At 1 year, 2 year, and 3 years post procedure

    The secondary safety endpoint is defined as the composite device-related serious adverse cardiac event rate at 12-months and annually through 36 months.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Surgery

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2029
First posted
Jan 12, 2024
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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