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Device
Penditure™ LAA Exclusion System for Left Atrial Appendage Closure
N/A
Recruiting
Research Sponsored by Medtronic Cardiac Surgery
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Greater than or equal to 18 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 year, 2 year, and 3 years post procedure
Awards & highlights
Study Summary
"This trial aims to gather real-world data on how well the Penditure™ LAA Exclusion System works and its impact on patients' health outcomes during heart surgery."
Who is the study for?
This trial is for adults over 18 who need the Penditure™ LAA Exclusion System as part of their cardiac surgery. Participants must be able to give informed consent and follow the study's visit schedule.Check my eligibility
What is being tested?
The study is evaluating the performance and outcomes of using the Penditure™ LAA Exclusion System in patients undergoing heart surgery.See study design
What are the potential side effects?
While specific side effects are not listed, they may include typical risks associated with cardiac surgery and devices like bleeding, infection, or device-related complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 year, 2 year, and 3 years post procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 year, 2 year, and 3 years post procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of successful exclusion of the LAA from the heart
Secondary outcome measures
Rate of device related adverse events
Rate of successful placement of the Penditure™ LAA Exclusion System
Trial Design
1Treatment groups
Experimental Treatment
Group I: Penditure™ LAA Exclusion SystemExperimental Treatment1 Intervention
Penditure™ LAA Exclusion System
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Who is running the clinical trial?
Medtronic Cardiac SurgeryLead Sponsor
7 Previous Clinical Trials
9,473 Total Patients Enrolled
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