CHF - Congestive Heart Failure
Conditions
Brief summary
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.
Interventions
PROCEDUREpreventive ablation group
for patients undergoing LVAD surgery while also undergoing prophylactic ablation of ventricular arrhythmias at the same time
Sponsors
The First Affiliated Hospital of Anhui Medical University
Shenzhen Core Medical Technology CO.,LTD.
Jiangsu Provincial People's Hospital (The First Affiliated Hospital of Nanjing Medical University)
The First Affiliated Hospital of Bengbu Medical University
Lu'an People's Hospital of Anhui Province
The First Affiliated Hospital of Xuzhou Medical College
First Affiliated Hospital of Wannan Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 1.voluntary and with the provision of an informed consent form 2.males or females aged 18 years or older 3.all patients with acute and critical or chronic advanced heart failure who have failed to respond to standardized oral medication and are scheduled to undergo artificial heart implantation surgery
Exclusion criteria
* 1.The left ventricular assist system is prohibited for patients who cannot tolerate anticoagulant therapy or who are allergic to anticoagulant treatment. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| persistent ventricular tachycardia / ventricular fibrillation | 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. |
| all-cause mortality | Within 30 days after the operation | Conduct a 30-day follow-up visit for the patients, and collect the time and cause of death. |
| mechanical thrombus | 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. |
| right heart failure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| all-cause mortality | 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. |
| mechanical thrombus | 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. |
| stroke | 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. |
| Hospitalization or emergency visit due to heart failure | 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. |
| heart transplantation | 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. |
Countries
China
Outcome results
None listed