Penditure™ System for Left Atrial Appendage Closure

Not currently recruiting at 16 trial locations

Overseen By Jennifer Bleifus

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Cardiac Surgery

Disqualifiers: Cardiac surgery history, Pericarditis, Thrombus, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 30

Duration: At the time of procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to gather evidence on the effectiveness of the Penditure™ System, a device designed to close the left atrial appendage (LAA) during heart surgery. It targets individuals requiring this specific heart procedure. Suitable candidates have not undergone previous attempts to close their LAA and do not require emergency heart surgery. Participants should also be free from conditions such as severe kidney disease or heart failure symptoms. The trial seeks to ensure the device performs safely and effectively for future patients. As an unphased trial, participants contribute to pioneering research that may enhance heart surgery outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the Penditure™ LAA Exclusion System is safe for left atrial appendage closure?

Research has shown that the Penditure™ Left Atrial Appendage (LAA) Exclusion System is generally safe. Previous studies found no major side effects, and a detailed check after using the system showed positive results.

However, complications can occur during open-heart surgery with this system, such as bleeding or tissue damage. One negative event related to the system has also been reported.

Overall, the treatment appears well-tolerated, but like any medical procedure, it carries risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Penditure™ Left Atrial Appendage (LAA) Exclusion System is unique because it offers a new approach to reducing the risk of stroke in patients with atrial fibrillation by physically excluding the left atrial appendage. Unlike traditional treatments like anticoagulants, which thin the blood to prevent clots, Penditure™ provides a mechanical solution that could eliminate the need for ongoing medication and its associated bleeding risks. Researchers are excited about this treatment because it promises a potentially safer, more durable alternative to managing stroke risk without the long-term side effects of drugs.

What evidence suggests that the Penditure™ LAA Exclusion System is effective for left atrial appendage closure?

Studies have shown that the Penditure™ Left Atrial Appendage (LAA) Exclusion System effectively closes the left atrial appendage during heart surgeries. Participants in this trial will receive this system, which uses a special clip to seal off the LAA, a small pouch in the heart where blood clots can form. Closing this area may reduce the risk of stroke in patients with certain heart conditions. Early results suggest that the system performs well and provides positive outcomes for patients. Experts often recommend LAA closure devices like Penditure™ to help prevent strokes in eligible patients during heart surgeries. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Patient is indicated to be treated with the Penditure™ LAA Exclusion System

The subject is willing and able to provide written informed consent and comply with study visit requirements

Exclusion Criteria

Subject is contraindicated for MDCT and/or TEE

Life expectancy of less than 12 months

Patient has a documented history of substance (drug or alcohol) abuse

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cardiac surgery and are implanted with the Penditure™ Left Atrial Appendage (LAA) Exclusion Clip

At the time of procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

Visits at 30 days, 3 months, 12 months, and annually for 36 months

What Are the Treatments Tested in This Trial?

Interventions

• Penditure™ LAA Exclusion System

Trial Overview The study is evaluating the performance and outcomes of using the Penditure™ LAA Exclusion System in patients undergoing heart surgery.

How Is the Trial Designed?

Group I: Penditure™ Left Atrial Appendage (LAA) Exclusion System Experimental Treatment 1 Intervention

Penditure™ Left Atrial Appendage (LAA) Exclusion System

Penditure™ LAA Exclusion System is already approved in United States for the following indications:

Approved in United States as Penditure LAA Exclusion System for:

• Left atrial appendage exclusion in patients undergoing concomitant cardiac surgery

Who Is Running the Clinical Trial?

Medtronic Cardiac Surgery

Lead Sponsor

Trials

10

Recruited

9,900+

Published Research Related to This Trial

The LAmbre LAA closure device was used in a compassionate use case for a 79-year-old male patient with non-valvular atrial fibrillation, highlighting its potential as a treatment option for patients at high risk for anticoagulation therapy.

This case underscores the challenges posed by the anatomical variability of the left atrial appendage, which can complicate LAA occlusion procedures with existing technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left Atrial Appendage Occlusion With the LAmbre Device: First-in-Human in the United States. Qintar, M., Wang, DD., Lee, J., et al.[2021]

Surgical exclusion of the left atrial appendage (LAA) is an important method for preventing strokes in high-risk patients with atrial fibrillation who cannot manage their condition with medication or are undergoing other heart surgeries.

Different surgical techniques for LAA exclusion, such as excision and internal ligation, are chosen based on individual patient factors like their medical history and the anatomy of the appendage, highlighting the need for personalized treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient selection and methods of surgical left atrial appendage exclusion. Greenberg, JW., Lee, R., Hui, DS.[2021]

The percutaneous ligation of the left atrial appendage (LAA) using the SentreHeart LARIAT device showed a high acute procedural success rate of 92.6% in 27 patients with atrial fibrillation who were at high risk for stroke and could not tolerate anticoagulation therapy.

While the procedure had some complications, including three cases of pericarditis and one stroke, there were no deaths, indicating that LAA exclusion can be performed safely with acceptable short-term risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early results with the LARIAT device for left atrial appendage exclusion in patients with atrial fibrillation at high risk for stroke and anticoagulation. Stone, D., Byrne, T., Pershad, A.[2016]

Excluding the left atrial appendage (LAA) during cardiac surgery can significantly lower the risk of stroke in patients with atrial fibrillation, as the LAA is a primary source of blood clots.

The TigerPaw II system, a device used for LAA closure, showed a high rate of malfunction in our experience, indicating a need for design improvements to enhance safety and efficacy in surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exclusion of the left atrial appendage with the TigerPaw II system: a word of caution. Ventosa-Fernandez, G., Quintana, E., Castellá, M., et al.[2015]

In a study of 25 patients undergoing left atrial appendage closure (LAAC) for stroke prevention, 48% showed acute brain lesions immediately after the procedure, but 71% of those lesions were no longer detectable after three months.

Neurocognitive function, assessed using the MoCA test and NIHSS score, showed no significant changes immediately after LAAC or at the three-month follow-up, suggesting that LAAC does not adversely affect cognitive abilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term follow up of 3 T MRI-detected brain lesions after percutaneous catheter-based left atrial appendage closure. Bellmann, B., Rillig, A., Skurk, C., et al.[2019]

In a study of 55 elderly patients with nonvalvular atrial fibrillation, the LAmbreTM device achieved a high procedural success rate of 98.2% and a 100% device success rate, indicating its effectiveness for left atrial appendage closure.

The device demonstrated a favorable safety profile, with a low incidence of major complications (1.8% mortality and 3.6% pericardial tamponade) and no strokes reported during the 12-month follow-up, suggesting it is a viable option for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left Atrial Appendage Closure with a New Occluder Device: Efficacy, Safety and Mid-Term Performance. Llagostera-Martín, M., Cubero-Gallego, H., Mas-Stachurska, A., et al.[2021]

The study demonstrated that left atrial appendage (LAA) ligation using a natural orifice transluminal endoscopic surgery (NOTES) approach is feasible and safe in an animal model, with no adverse events reported during the survival period.

The procedure was successfully completed in all but one of the pigs, with an average ligation time of 34.4 minutes, suggesting that this method could serve as an alternative to long-term anticoagulant therapy for high-risk patients with atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left atrial appendage ligation with single transthoracic port assistance: a study of survival assessment in a porcine model (with videos). Moreira-Pinto, J., Ferreira, A., Miranda, A., et al.[2012]

Citations

1. medtronic.com medtronic.com/en-us/healthcare-professionals/products/cardiovascular/left-atrial-appendage-exclusion-systems/penditure-laa-exclusion-system.html

Penditure™ LAA Exclusion System The Penditure™ LAA exclusion system consists of a single-use, sterile, self-closing implant (clip) preloaded on a disposable delivery system.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06203054?term=penditure&rank=1

Study Details | NCT06203054 | 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) ...

3. withpower.com withpower.com/trial/penditure-system-for-left-atrial-appendage-closure-24f96

Penditure™ System for Left Atrial Appendage Closure The purpose of this study is to collect post-market clinical evidence on performance and clinical outcomes of the Penditure™ Left Atrial Appendage (LAA) ...

4. news.medtronic.com news.medtronic.com/Medtronic-adds-innovative-Penditure-TM-Left-Atrial-Appendage-Exclusion-System-to-Cardiac-Surgery-portfolio

Medtronic adds innovative Penditure™ Left Atrial ... The study will aim to further evaluate the performance and clinical outcomes of the Penditure™ LAA Exclusion System in subjects undergoing ...

5. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=19792974&pc=PZX

PERFUSION SYSTEMS PENDITURE LAA EXCLUSION ... Medtronic received information that the customer implanted a penditure laa clip as part of a concomitant left atrial appendage (laa) exclusion during an aortic ...

6. medtronic.com medtronic.com/content/dam/medtronic-wide/public/united-states/products/cardiac-vascular/cardiovascular/left-atrial-appendage-exclusion-systems/penditure-laa-product-brochure.pdf

Penditure™ LAA Exclusion System Possible complications related to the use of Penditure™ LAA exclusion system in combination with open heart surgery are: bleeding, tissue damage, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11335376/

Left atrial appendage closure for stroke prevention in ... LAA closure (LAAC) emerges as an alternative or complementary treatment approach to reduce the risk of stroke or systemic embolism in patients with AF.