CLIP-IT Post-Market Study

Medtronic

Status

Active, not recruiting

Conditions

Left Atrial Appendage Exclusion

Treatments

Device: Penditure™ Left Atrial Appendage (LAA) Exclusion System

Study type

Interventional

Funder types

Industry

Identifiers

NCT06203054

MDT22049

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)