Penditure™ System for Left Atrial Appendage Closure
Recruiting in Palo Alto (17 mi)
+14 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Medtronic Cardiac Surgery
Disqualifiers: Cardiac surgery history, Pericarditis, Thrombus, others
No Placebo Group
Approved in 1 jurisdiction
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.
12345Is 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.
12467Eligibility 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
I am 18 years old or older.
Exclusion Criteria
I need urgent heart surgery.
I have had heart surgery in the past.
I have been diagnosed with pericarditis.
I need a heart transplant or surgery for a severe heart or aortic condition.
I have severe heart failure symptoms.
I have tried to isolate my left atrial appendage before.
I have a blood clot in my heart's left side.
Participant Groups
The study is evaluating the performance and outcomes of using the Penditure™ LAA Exclusion System in patients undergoing heart surgery.
1Treatment groups
Experimental Treatment
Group I: Penditure™ Left Atrial Appendage (LAA) Exclusion SystemExperimental Treatment1 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
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Corewell HealthGrand Rapids, MI
Lankenau Institute for Medical ResearchWynnewood, PA
Mayo Clinic Saint Marys CampusRochester, MN
Barnes-Jewish HospitalSaint Louis, MO
More Trial Locations
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Who is running the clinical trial?
Medtronic Cardiac SurgeryLead Sponsor
References
Exclusion of the left atrial appendage with the TigerPaw II system: a word of caution. [2015]Exclusion of the left atrial appendage (LAA) may significantly reduce the incidence of stroke associated with atrial fibrillation (AF), since this is the main thrombus source. LAA closure is becoming a therapeutic target for preventing AF-related stroke, attracting much interest in recent years. Different devices are available to provide LAA exclusion during cardiac surgery. We describe herein our experience with the recently introduced TigerPaw II system for LAA exclusion, and report a high prevalence of device malfunction. Design improvements may address these issues and increase safety for new technological devices designed for surgical LAA closure.
Left atrial appendage ligation with single transthoracic port assistance: a study of survival assessment in a porcine model (with videos). [2012]Left atrial appendage (LAA) exclusion is a well-known procedure for the prevention of stroke in high-risk patients with atrial fibrillation and contraindication to long-term oral anticoagulant therapy.
Long-term follow up of 3 T MRI-detected brain lesions after percutaneous catheter-based left atrial appendage closure. [2019]Left atrial appendage closure (LAAC) for stroke prevention is an increasingly performed intervention.
Left Atrial Appendage Occlusion With the LAmbre Device: First-in-Human in the United States. [2021]The left atrial appendage (LAA) is a highly variable anatomical structure, which may pose a challenge to successful LAA occlusion with currently approved technology. We present our experience with the compassionate use of the LAmbre LAA closure device (Lifetecha) for a 79-year-old male patient with non-valvular atrial fibrillation and multiple falls who was considered high risk for anticoagulation therapy.
Patient selection and methods of surgical left atrial appendage exclusion. [2021]The left atrial appendage (LAA) is a major source of thromboembolism, particularly in patients with atrial fibrillation (AF). LAA exclusion has arisen as a method of stroke prophylaxis in high-risk patients who have failed medical management, in whom medical management is contraindicated, and in those undergoing concomitant cardiac surgery. Percutaneous LAA exclusion with devices such as the Watchman has been described extensively in the cardiology literature, but surgical exclusion is less often discussed. Several techniques exist for surgical LAA exclusion, including appendage excision (removal), internal ligation from within the left atrium (LA), and external occlusion without opening the LA. The decision of which surgical technique to employ is dependent upon individual patient characteristics including risk factors, surgical history, and appendage anatomy. This paper discusses patient selection for surgical LAA exclusion and methods of surgical exclusion for the non-cardiac surgery medical practitioner.
Left Atrial Appendage Closure with a New Occluder Device: Efficacy, Safety and Mid-Term Performance. [2021]The LAmbreTM device is a novel system designed for left atrial appendage closure (LAAC). First registries showed a high rate of device implantation success. However, few mid-term results are available. We present our 1- and 12-month follow-up results for this device. This prospective, single-center registry included consecutive patients with nonvalvular atrial fibrillation who underwent LAAC with the LAmbreTM device. Transesophageal echocardiography (TEE) was performed at 1-month follow-up. In total, 55 patients were included. The population was elderly (75 ± 9.4 years), with a high proportion of comorbidities. The mean CHA2DS2-VASc and HAS-BLED scores were 4.6 ± 1.6 and 3.9 ± 1.0, respectively. Previous history of a major bleeding event was present in 37 patients (67.3%). Procedural success was achieved in 54 patients (98.2%). Device success was achieved in 100% of patients in whom device implantation was attempted (54 patients). Major in-hospital device-related complications included mortality of one patient (1.8%) and pericardial tamponade in two patients (3.6%); the incidence of stroke was 0%. No thrombus or significant leaks (≥5 mm) were observed on 1-month TEE. At 12 months, adverse events were overall death (1.8%), transient ischemic attack/ischemic stroke (1.8%), and major bleeding events (Bleeding Academic Research Consortium (BARC) 3a and 3c; 11%). In this high-risk population, the LAmbreTM device seems to be a safe and effective option for LAAC with a remarkable mid-term performance.
Early results with the LARIAT device for left atrial appendage exclusion in patients with atrial fibrillation at high risk for stroke and anticoagulation. [2016]To evaluate early outcomes of left atrial appendage (LAA) closure via a percutaneous LAA ligation approach with the SentreHeart LARIAT(™) snare device.