Left Atrial Appendage ExclusionNCT06203054
CLIP-IT Post-Market Study
A study testing Penditure™ Left Atrial Appendage (LAA) Exclusion System in people with Left Atrial Appendage Exclusion, run by Medtronic Cardiac Surgery at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Atrial Appendage Exclusion
- What is being tested?
- Penditure™ Left Atrial Appendage (LAA) Exclusion System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 15 sitesUnited States
- Study dates
- 26 Feb 2024to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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)
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Ascension St. Vincent Heart Center
Carmel, Indiana, 46290
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Corewell Health
Grand Rapids, Michigan, 49503
UPMC Pinnacle Harrisburg Campus
Harrisburg, Pennsylvania, 17101
Houston Methodist Hospital
Houston, Texas, 77030
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
Mayo Clinic Saint Marys Campus
Rochester, Minnesota, 55905
Swedish Medical Center Cherry Hill
Seattle, Washington, 98112
Barnes Jewish Hospital
St Louis, Missouri, 63110
Saint Joseph's Hospital Health Center
Syracuse, New York, 13203
ProMedica Toledo Hospital
Toledo, Ohio, 43606
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, 19096
About this study
Official title: exClusion of the Left atrIal Appendage With PendITure™ (CLIP-IT) Post-Market Study
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.
Read the detailed 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.
- Conditions
- Left Atrial Appendage Exclusion
- Being tested
- Penditure™ Left Atrial Appendage (LAA) Exclusion System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penditure™ Left Atrial Appendage (LAA) Exclusion SystemDevice
Exclusion of the left atrial appendage using the Penditure™ Left Atrial Appendage (LAA) Exclusion System in subjects undergoing concomitant cardiac surgery.
| Study group | Role | What they receive |
|---|---|---|
| Penditure™ Left Atrial Appendage (LAA) Exclusion System | Experimental | Penditure™ Left Atrial Appendage (LAA) Exclusion System Receives: Device: Penditure™ Left Atrial Appendage (LAA) Exclusion System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful exclusion of the left atrial appendage (LAA) from the heart
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.
Measured: 3 months post procedure
Rate of device related adverse events
The primary safety endpoint is the composite rate of device-related serious adverse cardiac events at 30-days post-procedure.
Measured: 30 days post procedure
Secondary outcomes (2)
Rate of successful placement of the Penditure™ left atrial appendage (LAA) Exclusion System
The secondary efficacy endpoint is defined as the rate of successful placement of the Penditure™ LAA Exclusion System defined as < 10 mm of residual stump proximal to the clip at the time of the procedure (measured by intraoperative TEE with doppler) without tissue damage requiring intervention.
Measured: At the time of procedure
Rate of device related adverse events
The secondary safety endpoint is defined as the composite device-related serious adverse cardiac event rate at 12-months and annually through 36 months.
Measured: At 1 year, 2 year, and 3 years post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start26 Feb 2024
- Primary completion26 Aug 2025
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Atrial Appendage ExclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203054
- Sponsor's protocol ID
- MDT22049
- Status last verified
- Apr 2026
- First submitted
- 2 Jan 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- exClusion of the Left atrIal Appendage With PendITure™ (CLIP-IT) Post-Market Study
- ClinicalTrials.gov ID
- NCT06203054
- Acronym / sponsor ID
- MDT22049
- Conditions
- Left Atrial Appendage Exclusion
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Medtronic Cardiac SurgeryIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 26 Aug 2025 (actual)
- Study completion
- Feb 2029 (estimated)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Penditure™ Left Atrial Appendage (LAA) Exclusion System | Experimental | Device: Penditure™ Left Atrial Appendage (LAA) Exclusion SystemPenditure™ Left Atrial Appendage (LAA) Exclusion System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Penditure™ Left Atrial Appendage (LAA) Exclusion SystemExclusion of the left atrial appendage using the Penditure™ Left Atrial Appendage (LAA) Exclusion System in subjects undergoing concomitant cardiac surgery. | Device | Penditure™ Left Atrial Appendage (LAA) Exclusion System |
Primary outcome
Rate of successful exclusion of the left atrial appendage (LAA) from the heart
Time frame: 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 adverse events
Time frame: 30 days post procedure
The primary safety endpoint is the composite rate of device-related serious adverse cardiac events at 30-days post-procedure.
2 secondary outcomes
Rate of successful placement of the Penditure™ left atrial appendage (LAA) Exclusion System
Time frame: At the time of procedure
Rate of device related adverse events
Time frame: At 1 year, 2 year, and 3 years post procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Penditure™ Left Atrial Appendage (LAA) Exclusion System in people with Left Atrial Appendage Exclusion, run by Medtronic Cardiac Surgery at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of successful exclusion of the left atrial appendage (LAA) from the heart (time frame: 3 months post procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.