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CLIP-IT Post-Market Study

Recruiting
18 years of age
Both
Phase N/A

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Overview

The purpose of this study is to collect post-market clinical evidence on performance and clinical outcomes of the Penditure™ LAA Exclusion System in subjects undergoing concomitant cardiac surgery.

Description

Multi center, single-arm, nonrandomized, interventional, unblinded, post-market study. Up to 150 subjects will be enrolled and implanted with the Penditure™ 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.

Eligibility

Inclusion Criteria:

  • Patient is indicated to be treated with the Penditure™ 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 LAA isolation attempt(s)
  • Need for emergent cardiac surgery
  • Subject is contraindicated for MDCT and/or TEE
  • Life expectancy of less than 12 months
  • History of cardiac surgery
  • Pericarditis
  • Presence of thrombus in the left atrium or 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
  • 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 details

Left Atrial Appendage Exclusion

NCT06203054

Medtronic Cardiac Surgery

8 June 2024

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FAQs

Learn more about clinical trials

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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