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)
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Anhui
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Hefei, Anhui, China
- 5thBuilding, 9thFloor, High-tech Campus of the First Affiliated Hospital of Anhui Medical University
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: preventive ablation group
for patients undergoing LVAD surgery while also undergoing prophylactic ablation of ventricular arrhythmias at the same time
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for patients undergoing LVAD surgery while also undergoing prophylactic ablation of ventricular arrhythmias at the same time
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Geen tussenkomst: the control group without any treatment
no intervention measures
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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persistent ventricular tachycardia / ventricular fibrillation
Tijdsspanne: Continuous electrocardiogram monitoring for 30 days after surgery
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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.
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Continuous electrocardiogram monitoring for 30 days after surgery
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all-cause mortality
Tijdsspanne: Within 30 days after the operation
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Conduct a 30-day follow-up visit for the patients, and collect the time and cause of death.
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Within 30 days after the operation
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mechanical thrombus
Tijdsspanne: Within 30 days after the operation
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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.
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Within 30 days after the operation
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right heart failure
Tijdsspanne: Within 30 days after the operation
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Conduct a 30-day follow-up visit for the patients, and collect the time and cause of right heart failure.
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Within 30 days after the operation
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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all-cause mortality
Tijdsspanne: semi-annually, for a total of three years
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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.
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semi-annually, for a total of three years
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mechanical thrombus
Tijdsspanne: semi-annually, for a total of three years
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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.
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semi-annually, for a total of three years
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stroke
Tijdsspanne: semi-annually, for a total of three years
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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.
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semi-annually, for a total of three years
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Hospitalization or emergency visit due to heart failure
Tijdsspanne: semi-annually, for a total of three years
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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.
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semi-annually, for a total of three years
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heart transplantation
Tijdsspanne: semi-annually, for a total of three years
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Patients are followed up in the outpatient department or by phone every six months, and the necessary medical history records are collected.
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semi-annually, for a total of three years
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Medewerkers en onderzoekers
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ChiCTR2600117097 (Andere identificatie: The First Affiliated Hospital of Anhui Medical University)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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