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Device
Penditure™ 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
Must not have
Need for emergent cardiac surgery
History of cardiac surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 year, 2 year, and 3 years post procedure
Awards & highlights
No Placebo-Only Group
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.
What is being tested?
The study is evaluating the performance and outcomes of using the Penditure™ LAA Exclusion System in patients undergoing heart surgery.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need urgent heart surgery.
Select...
I have had heart surgery in the past.
Select...
I have been diagnosed with pericarditis.
Select...
I need a heart transplant or surgery for a severe heart or aortic condition.
Select...
I have severe heart failure symptoms.
Select...
I have tried to isolate my left atrial appendage before.
Select...
I have a blood clot in my heart's left side.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rate of successful exclusion of the left atrial appendage (LAA) from the heart
Secondary study objectives
Rate of device related adverse events
Rate of successful placement of the Penditure™ left atrial appendage (LAA) Exclusion System
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Penditure™ Left Atrial Appendage (LAA) Exclusion SystemExperimental Treatment1 Intervention
Penditure™ Left Atrial Appendage (LAA) Exclusion System
Find a Location
Who is running the clinical trial?
Medtronic Cardiac SurgeryLead Sponsor
9 Previous Clinical Trials
9,744 Total Patients Enrolled