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.

NCT07589738 | Active Not Recruiting

• 1 other identifier: ChiCTR2600117097
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

CHF - Congestive Heart Failure

Outcome Measures

Primary Outcomes (4)

• persistent ventricular tachycardia / ventricular fibrillation

  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.

  Continuous electrocardiogram monitoring for 30 days after surgery

• all-cause mortality

  Conduct a 30-day follow-up visit for the patients, and collect the time and cause of death.

  Within 30 days after the operation

• mechanical thrombus

  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.

  Within 30 days after the operation

• right heart failure

  Conduct a 30-day follow-up visit for the patients, and collect the time and cause of right heart failure.

  Within 30 days after the operation

Secondary Outcomes (5)

• 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

Study Arms (2)

preventive ablation group

EXPERIMENTAL

for patients undergoing LVAD surgery while also undergoing prophylactic ablation of ventricular arrhythmias at the same time

Procedure: preventive ablation group

the control group without any treatment

NO INTERVENTION

no intervention measures

Interventions

preventive ablation group PROCEDURE

for patients undergoing LVAD surgery while also undergoing prophylactic ablation of ventricular arrhythmias at the same time

preventive ablation group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The left ventricular assist system is prohibited for patients who cannot tolerate anticoagulant therapy or who are allergic to anticoagulant treatment.
• 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.
• 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.
• primary pulmonary hypertension. 9.Having a confirmed and untreated history of abdominal or thoracic aortic aneurysm with a diameter greater than 5 cm.
• 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.
• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Anhui Medical University: lead
• Shenzhen Core Medical Technology CO.,LTD.: collaborator
• Jiangsu Provincial People's Hospital (The First Affiliated Hospital of Nanjing Medical University): collaborator
• Lu'an People's Hospital of Anhui Province: collaborator
• The First Affiliated Hospital of Xuzhou Medical College: collaborator
• First Affiliated Hospital of Wannan Medical College: collaborator
• The First Affiliated Hospital of Bengbu Medical University: collaborator

Study Sites (1)

5thBuilding, 9thFloor, High-tech Campus of the First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: May 10, 2026
• First Posted: May 15, 2026
• Study Start: January 31, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: May 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)