Penditure™ System for Left Atrial Appendage Closure

Recruiting at 15 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

150 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the Penditure™ LAA Exclusion System treatment?

Research shows that closing the left atrial appendage (LAA) can help prevent strokes in people with atrial fibrillation (a heart rhythm disorder) who cannot take blood thinners. Similar devices, like the Watchman, have been used successfully for this purpose, suggesting that the Penditure™ system might also be effective. ^{1 2 3 4 5}

Is the Penditure™ System for Left Atrial Appendage Closure safe for humans?

The TigerPaw II system for left atrial appendage closure showed a high rate of device malfunction, indicating potential safety concerns. In contrast, the LAmbreTM device had a high success rate with some complications, such as pericardial tamponade (fluid buildup around the heart) and major bleeding events, but was generally considered safe in a high-risk population. ^{1 2 4 6 7}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Exclusion of the left atrial appendage with the TigerPaw II system: a word of caution. [2015]

2. United States 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). [2012]

3. United States pubmed.ncbi.nlm.nih.gov

Long-term follow up of 3 T MRI-detected brain lesions after percutaneous catheter-based left atrial appendage closure. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Left Atrial Appendage Occlusion With the LAmbre Device: First-in-Human in the United States. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Patient selection and methods of surgical left atrial appendage exclusion. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Left Atrial Appendage Closure with a New Occluder Device: Efficacy, Safety and Mid-Term Performance. [2021]

7. United States 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. [2016]