Ireland
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Active, not recruiting Not applicable

CLIP-IT Post-Market Study

NCT06203054 · tracked via the Priya Life Science USA tracker
Phase
Not applicable
Started
2024-02-26
Last updated
2026-10-29

Condition(s) studied

Left Atrial Appendage Exclusion

Investigational drug(s) / intervention(s)

Penditure™ Left Atrial Appendage (LAA) Exclusion System

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Rate of Successful Exclusion of the Left Atrial Appendage (LAA) From the Heart — 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.
  • Rate of Device-related Serious Adverse Cardiac Events — 30 days post procedure
    The primary safety endpoint is the composite rate of device-related serious adverse cardiac events at 30-days post-procedure.

Trial sites (15)

FacilityCityRegionStatus
Emory Saint Joseph's Hospital Atlanta Georgia
Northwestern Memorial Hospital Chicago Illinois
Ascension St. Vincent Heart Center Carmel Indiana
University of Michigan Health System Ann Arbor Michigan
Corewell Health Grand Rapids Michigan
Mayo Clinic Saint Marys Campus Rochester Minnesota
Barnes Jewish Hospital St Louis Missouri
Saint Joseph's Hospital Health Center Syracuse New York
University Hospitals Cleveland Medical Center Cleveland Ohio
ProMedica Toledo Hospital Toledo Ohio
UPMC Pinnacle Harrisburg Campus Harrisburg Pennsylvania
University of Pittsburgh Medical Center UPMC Presbyterian Pittsburgh Pennsylvania
Lankenau Institute for Medical Research Wynnewood Pennsylvania
Houston Methodist Hospital Houston Texas
Swedish Medical Center Cherry Hill Seattle Washington

More Medtronic Cardiac Surgery trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06203054 on ClinicalTrials.gov ↗ ← All trials in the USA