A Prospective, Randomized, Blind, Controlled Multicenter Clinical Study Comparing the Effectiveness of Preventive Ventricular Arrhythmia Ablation on the Prognosis After Left Ventricular Assist Device (LVAD) Surgery.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- persistent ventricular tachycardia / ventricular fibrillation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
preventive ablation group
for patients undergoing LVAD surgery while also undergoing prophylactic ablation of ventricular arrhythmias at the same time
Intervention: preventive ablation group (Procedure)
the control group without any treatment
no intervention measures
Outcomes
Primary Outcomes
persistent ventricular tachycardia / ventricular fibrillation
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.
all-cause mortality
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.
mechanical thrombus
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.
right heart failure
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.
Secondary Outcomes
- all-cause mortality(semi-annually, for a total of three years)
- mechanical thrombus(semi-annually, for a total of three years)
- stroke(semi-annually, for a total of three years)
- Hospitalization or emergency visit due to heart failure(semi-annually, for a total of three years)
- heart transplantation(semi-annually, for a total of three years)
Investigators
ChengxinZhang
Chief Physician
The First Affiliated Hospital of Anhui Medical University