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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 below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 year, 2 year, and 3 years post procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 year, 2 year, and 3 years post procedure for reporting.

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

Find a Location

Who is running the clinical trial?

Medtronic Cardiac SurgeryLead Sponsor
7 Previous Clinical Trials
9,473 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently able to apply and participate in this ongoing research study?

"Yes, the details available on clinicaltrials.gov confirm that this trial is actively seeking eligible participants. The trial was first listed on January 31st, 2024 and most recently revised on February 7th, 2024. It aims to enroll a total of 150 patients at a single site."

Answered by AI

What is the current number of participants being recruited for this clinical study?

"Affirmative. The data on clinicaltrials.gov reveals that this specific clinical trial is presently seeking volunteers. Initially shared on January 31, 2024, and most recently revised on February 7, 2024, the study aims to recruit 150 participants from a single site."

Answered by AI
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