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NCT Number: NCT07589738

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.

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Hefei, Anhui, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

preventive ablation group

Procedure

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  1. all-cause mortality

    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.

  2. mechanical thrombus

    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.

  3. stroke

    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.

  4. Hospitalization or emergency visit due to 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, 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.

  5. heart transplantation

    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.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Anhui Medical University

Other

Collaborators

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

Registry information

Acronym: PAVA-LVAD

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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