5thBuilding, 9thFloor, High-tech Campus of the First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
NCT Number: NCT07589738
To compare the preventive effect of preventive ventricular arrhythmia ablation on the composite events 30 days after surgery in the study population. The composite events defined in this study 30 days after surgery include persistent ventricular tachycardia/ventricular fibrillation, all-cause death, mechanical thrombosis and right heart failure.
This study is active but is not currently recruiting participants.
Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Hefei, Anhui, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2.Doctors with sufficient experience will make a comprehensive judgment based on the patient's physical condition, body surface area, and the anatomical-related conditions of the planned implantation site, and determine those who are not suitable for the implantation procedure.
3.Pregnant women. 4.Systemic active infection. 5.Patients in a state of brain death. 6.Irreversible severe liver or kidney dysfunction. 7.Having a history of severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease.
8.primary pulmonary hypertension. 9.Having a confirmed and untreated history of abdominal or thoracic aortic aneurysm with a diameter greater than 5 cm.
10.Patients with severe atherosclerotic plaques in the aorta. 11.Having mental disorders/impairments, irreversible cognitive dysfunction, or social-psychological problems, which makes it possible for the patient to fail to comply with the application management regulations of the implanted left ventricular assist device.
12.Preoperative conditions included end-stage organ failure, such as renal failure (requiring hemodialysis), liver failure, respiratory failure; and concurrent malignant tumors or any severe accompanying diseases with an expected lifespan of less than 3 years.
for patients undergoing LVAD surgery while also undergoing prophylactic ablation of ventricular arrhythmias at the same time
Time frame: Continuous electrocardiogram monitoring for 30 days after surgery
Electrocardiogram monitoring was conducted daily for the patients 30 days after the surgery. Data were uploaded daily and the frequency of arrhythmia occurrences was statistically analyzed.
Time frame: Within 30 days after the operation
Conduct a 30-day follow-up visit for the patients, and collect the time and cause of death.
Time frame: Within 30 days after the operation
Electrocardiogram monitoring was performed daily on the patients 30 days after the surgery. When thrombosis occurred, the left heart assist device would give an alarm to alert. In some cases, autopsy could be conducted to obtain the results.
Time frame: Within 30 days after the operation
Conduct a 30-day follow-up visit for the patients, and collect the time and cause of right heart failure.
Time frame: semi-annually, for a total of three years
Patients are followed up in the outpatient department or by phone every six months to collect death-related records such as death certificates and discharge summaries.
Time frame: semi-annually, for a total of three years
The artificial heart device implanted in the patient will continuously monitor. When a thrombosis occurs, the left heart assist device will alert and remotely contact the medical team. In some cases, this information can be obtained through autopsy after death.
Time frame: semi-annually, for a total of three years
Patients are followed up in the outpatient department or by phone every six months, and the necessary medical history records, imaging reports (such as head CT or MRI), and other original materials are collected.
Time frame: semi-annually, for a total of three years
Patients are followed up in the outpatient department or by phone every six months, and the necessary medical history records are collected, including symptoms such as shortness of breath and signs such as lower extremity edema, measurement of brain natriuretic peptide levels, and treatment with diuretics, etc.
Time frame: semi-annually, for a total of three years
Patients are followed up in the outpatient department or by phone every six months, and the necessary medical history records are collected.
The First Affiliated Hospital of Anhui Medical University
Other
Acronym: PAVA-LVAD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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