None listed
Conditions
Brief summary
Adjunct Left Atrial Appendage Exclusion During Lung Cancer Resection (ALAAEX) The purpose of study is to determine if closing off the small sac attached to the heart called the left atrial appendage (LAA) with a surgical device known as the AtriClip reduces stroke occurrence. Patients on this study will have atrial fibrillation (AF) and be undergoing a lung cancer resection.
Interventions
Placement of the AtriClip Left Atrial Appendage (LAA) Exclusion System is a specialized device designed to permanently close the LAA, a small pouch on the heart's exterior. By pinching the LAA shut, the clip prevents blood from stagnating, thereby significantly reducing the risk of stroke-causing blood clots.
Eligible, consented patients will receive a LAA ligation clip at the time of their primary surgery (left sided lobectomy or segmentectomy performed via thoracoscopic or robotic approach) fo
Placement of the AtriClip Left Atrial Appendage (LAA) Exclusion System is a specialized device designed to permanently close the LAA, a small pouch on the heart's exterior. By pinching the LAA shut, the clip prevents blood from stagnating, thereby significantly reducing the risk of stroke-causing blood clots. Eligible, consented patients will receive a LAA ligation clip at the time of their primary surgery (left sided lobectomy or segmentectomy performed via thoracoscopic or robotic approach) for lung cancer. Patients will require an intraoperative transoesophageal echocardiogram monitoring during LAA clip placement. A specialist cardiothoracic surgeon will place the clip, and the LAA clip adds around two to five minutes to the total surgery time. The approximate duration of the lung cancer surgery is two hours. Adherence to the intervention will be monitored through audit of the operation notes. As per the reference guidelines available in theatre, the transesophageal echocardiogram will be reviewed intraoperatively post clip placement and operation note will report on residual stump and no flow. The records will include the size and lot number of the clip device. The TOE images will remain in the patient records indefinitely.
Sponsors
Waikato Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
-Aged over 18 years, and less than 80 years -Known preoperative atrial fibrillation -NSCLC histology -Left-sided lung malignancy -Clinical stage 1 (Tumour size <3cm = T1a-T1c, N0, M0) -Lobar or sublobar (segmentectomy) resection feasible (based on standard tumour location and pulmonary function tests/spirometry values; patient would not be consented for surgery otherwise) -Thoracoscopic (multi-port, uniportal) or robotic resection feasible (based on operating surgeon) -Elective surgery -At least 3-year life expectancy (related to other comorbidities, etc)
Exclusion criteria
-Unresectable malignancy (chest wall involvement, carcinomatosis, bulky lymphadenopathy, etc) found at surgery -Active infection (pneumonia) -Associated haemorrhage with tumour -Sleeve or multi-lobar resection (planned or required) -Prior chest radiation -Prior cardiac surgery or left sided chest intervention -Prior intra-pericardial intervention (epicardial ablation, effusion drainage, etc) -Prior pericarditis -Prior attempted LAA occlusion (surgical or percutaneous) -Prior intra-cardiac device placement (ASD occlusion device, permanent pacemaker or implanted cardioverter/defibrillator) -Prior TIA, CVA, cardioembolism, ventricular thrombus, or pulmonary embolism -Pathologic/Histologic upstage > stage 1 -Conversion to thoracotomy -Mixed histology -LAA not completely excluded -Nitinol or Nickel allergy/sensitivity -Carotid stenosis >70%, carotid bruit, prior carotid intervention (endarterectomy, stent, bypass) -Prior traumatic brain injury -Prior intracranial pathology or procedure (ventriculo-peritoneal shunt, intracranial mass resection, haemorrhage with or without evacuation/decompression) -Multi-lobar resection or pneumonectomy required at operation -Prior malignancy -Prior oesophageal or gastric surgery (gastrectomy, oesophagectomy, oesophageal myotomy, gastric sleeve or Roux-en-Y bypass) – yielding limited facilitation of intraoperative echocardiography -Oesophageal motility disorder (achalasia, etc) -Known oesophageal pathology (leiomyoma, stricture, etc) -Inability to provide informed consent -Patent foramen ovale (including that observed on intraoperative TOE)
Outcome results
None listed