CLIP-IT Post-Market Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-26

Study Completion Date

2029-02-28

Brief Summary

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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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Detailed Description

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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.

Conditions

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Left Atrial Appendage Exclusion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Penditure™ Left Atrial Appendage (LAA) Exclusion System

Group Type EXPERIMENTAL

Penditure™ Left Atrial Appendage (LAA) Exclusion System

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No