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CHF - Congestive Heart FailurePAVA-LVADNCT07589738

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.

A study testing preventive ablation group in people with CHF - Congestive Heart Failure, run by The First Affiliated Hospital of Anhui Medical University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
CHF - Congestive Heart Failure
What is being tested?
preventive ablation group
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteChina
Study dates
31 Jan 2026to 30 Sep 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Hefei, Anhui

Other trials in China

About this study

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.

Being tested
preventive ablation group
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • preventive ablation groupProcedure or surgery

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

Study groups in NCT07589738
Study groupRoleWhat they receive
preventive ablation groupExperimentalfor patients undergoing LVAD surgery while also undergoing prophylactic ablation of ventricular arrhythmias at the same time
Receives: Procedure: preventive ablation group
the control group without any treatmentNo interventionno intervention measures

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Continuous electrocardiogram monitoring for 30 days after surgery

  2. all-cause mortality

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

    Measured: Within 30 days after the operation

  3. 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.

    Measured: Within 30 days after the operation

  4. right heart failure

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

    Measured: Within 30 days after the operation

Secondary outcomes (5)

  1. 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.

    Measured: semi-annually, for a total of three years

  2. 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.

    Measured: semi-annually, for a total of three years

  3. 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.

    Measured: semi-annually, for a total of three years

  4. 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.

    Measured: semi-annually, for a total of three years

  5. heart transplantation

    Patients are followed up in the outpatient department or by phone every six months, and the necessary medical history records are collected.

    Measured: semi-annually, for a total of three years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2026
  2. Study start31 Jan 2026
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07589738
Sponsor's protocol ID
ChiCTR2600117097
Other IDs
ChiCTR2600117097
Acronym
PAVA-LVAD
Status last verified
Apr 2026
First submitted
10 May 2026
Last updated
15 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing preventive ablation group in people with CHF - Congestive Heart Failure, run by The First Affiliated Hospital of Anhui Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

persistent ventricular tachycardia / ventricular fibrillation (time frame: Continuous electrocardiogram monitoring for 30 days after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07589738.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.

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