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. (PAVA-LVAD)

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 Overview

• Status: Active, not recruiting
• Conditions: CHF - Congestive Heart Failure
• Intervention / Treatment: Procedure: preventive ablation group

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: preventive ablation group; for patients undergoing LVAD surgery while also undergoing prophylactic ablation of ventricular arrhythmias at the same time	Procedure: preventive ablation group; for patients undergoing LVAD surgery while also undergoing prophylactic ablation of ventricular arrhythmias at the same time
No Intervention: the control group without any treatment; no intervention measures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
all-cause mortality	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.	semi-annually, for a total of three years
mechanical thrombus	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.	semi-annually, for a total of three years
stroke	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.	semi-annually, for a total of three years
Hospitalization or emergency visit due to heart failure	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.	semi-annually, for a total of three years
heart transplantation	Patients are followed up in the outpatient department or by phone every six months, and the necessary medical history records are collected.	semi-annually, for a total of three years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: May 10, 2026
• First Submitted That Met QC Criteria: May 10, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: ChiCTR2600117097 (Other Identifier: The First Affiliated Hospital of Anhui Medical University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No