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- Klinische proef NCT03693092
LAmbre™ Left Atrial Appendage Closure System Follow-Up Study
LAmbre™ Left Atrial Appendage Closure System Post-Market 2-5 Years Follow-Up Study
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
All subjects who completed 1-year follow-up of the LAmbreTM LAA system registration trial will be conducted 2 years, 3 years, 4 years and 5 years follow-up by the telephone call.
During the follow-up, the investigator or his/her designee will use a standardized form to record the occurrence of the subject's safety events and validity endpoint by telephone,and complete the safety and efficacy summary report. The endpoints of the study included compound events, MACCE events, stroke, haemorrhage and other events.
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
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Chengdu, China
- West China Hospital, Sichuan University
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Contact:
- Jian Jiang
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Beijing
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Beijing, Beijing, China
- Beijing Chaoyang Hospital, Capital Medical University
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Beijing, Beijing, China
- Fuwai Hospital Chinese Academy of Medical Science
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Contact:
- Yan Yao
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Heilongjiang
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Harbin, Heilongjiang, China
- The 2nd Affiliated Hospital of Harbin Medical University
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Contact:
- bo Yu
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Hubei
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Wuhan, Hubei, China
- Wuhan Asia Heart Hospital
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Contact:
- Xi Su
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Wuhan, Hubei, China
- People's Hospital of Wuhan University
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Contact:
- Congxin Huang
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Jiangsu
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Nanjing, Jiangsu, China
- Jiangsu Province Hospital
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Contact:
- Minglong Chen
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Liaoning
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Shenyang, Liaoning, China
- The General Hospital Of Shenyang Military Region
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Contact:
- Zulu Wang
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Shandong
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Dalian, Shandong, China
- The First Affiliated Hospital of Dalian Medical University
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Contact:
- Yanzong Yang
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Shanghai
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Shanghai, Shanghai, China
- Shanghai Tenth People's Hospital
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Contact:
- Yawei Xu
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Shanghai, Shanghai, China
- Xinhua Hospital Affiliated Shanghai Jiaotong University School of Medicine
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Contact:
- Yigang Li
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Patients who participated in the LAmbreTM Safety and Efficacy Study and completed the 1-year follow-up.
The inclusion criteria of LAmbreTM Safety and Efficacy Study:
- Age>=18, CHADS2 score>=1
- Patients cannot be treated long-term with Warfarin
- Eligible for clopidogrel and aspirin
- Provide written informed consent and agree to comply with the required follow-ups
Exclusion Criteria:
- Exclusion criteria: Patients who did not participate in the LAmbreTM Safety and Efficacy Study or did not complete 1-year follow-up LAmbreTM Safety and Efficacy Study.
The exclusion criteria of LAmbreTM Safety and Efficacy Study:
- Need to take Warfarin
- Presence of rheumatic, degenerative or congenital valvular heart diseases
- Early stage or paroxysmal atrial fibrillation
- Symptomatic patients with carotid artery disease (such as carotid stenosis>=50%)
- Heart failure NYHA grade IV
- Recent 30 days stroke or TIA
- Presence of active sepsis or endocarditis
- Cardiac tumours or other malignancy with estimated life expectancy <2 years
- Abnormal blood test; renal dysfunction
- LAA removed or heart implant patients
- Patients have planned electrophysiological ablation or cardioversion 30 days post implantation of the LAmbre system
- Patients have a history of mechanical prosthesis operation
- Patients who are pregnant, or desire to be pregnant during the during the study
- Participation in other trials
- A known allergy to nitinol
- Patients will not be able to complete the trial
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
The incidence of compound event
Tijdsspanne: 5 years after the surgery
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The compound event including death, systemic embolization, complications related to the device and requiring treatment (cardiac embolism, embolization, stroke, hemorrhage, death).
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5 years after the surgery
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
The incidence of MACCE events
Tijdsspanne: 2,3,4,5 years postoperative follow-up.
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The MACCE events including death (All cause death, All-cause death includes cardiac death, non-cardiac death and unexplained death), stroke, cardiac tamponade, and renal failure.
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2,3,4,5 years postoperative follow-up.
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Ischemic stroke rate
Tijdsspanne: 2,3,4,5 years postoperative follow-up
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Ischemic stroke is a neurological deficit caused by transient ischemic attack, cerebral thrombosis or cerebral embolism.
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2,3,4,5 years postoperative follow-up
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The rate of stroke
Tijdsspanne: 2,3,4,5 years postoperative follow-up
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Stroke is deviated into ischemic, hemorrhagic or undetermined stroke, and transient ischemic attacks (TIA).
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2,3,4,5 years postoperative follow-up
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The event of bleeding
Tijdsspanne: 2,3,4,5 years postoperative follow-up
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Intracranial or alimentary canal, or any bleeding that requires transfusion of 2 units of red blood cell suspension.
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2,3,4,5 years postoperative follow-up
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Cardiac events
Tijdsspanne: 2,3,4,5 years postoperative follow-up
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Non-fatal myocardial infarction, arrhythmia, cardiac tamponade, cardiogenic shock, endocarditis.
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2,3,4,5 years postoperative follow-up
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Congxin Huang, People's Hospital of Wuhan University
Studie record data
Bestudeer belangrijke data
Studie start (Verwacht)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
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
- LAA 2-5ys FU
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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