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LAmbre™ Left Atrial Appendage Closure System Follow-Up Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03693092
Recruitment Status : Unknown
Verified September 2018 by Lifetech Scientific (Shenzhen) Co., Ltd..
Recruitment status was:  Not yet recruiting
First Posted : October 2, 2018
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Lifetech Scientific (Shenzhen) Co., Ltd.

Study Description
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Brief Summary:
The purpose of this study is to conduct a continuous telephone follow-up study on subjects who had completed the one-year follow-up of the LAmbre™ left atrial appendage (LAA) system registration trial. The follow-up time was 2 years, 3 years, 4 years and 5 years after left atrial appendage closure operation, to evaluate the long-term safety and effectiveness of LAmbre™ LAA Closure System.

Condition or disease
Atrial Fibrillation

Detailed Description:

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.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 156 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: LAmbre™ Left Atrial Appendage Closure System Post-Market 2-5 Years Follow-Up Study
Estimated Study Start Date : November 20, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. The incidence of compound event [ Time Frame: 5 years after the surgery ]
    The compound event including death, systemic embolization, complications related to the device and requiring treatment (cardiac embolism, embolization, stroke, hemorrhage, death).


Secondary Outcome Measures :
  1. The incidence of MACCE events [ Time Frame: 2,3,4,5 years postoperative follow-up. ]
    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.

  2. Ischemic stroke rate [ Time Frame: 2,3,4,5 years postoperative follow-up ]
    Ischemic stroke is a neurological deficit caused by transient ischemic attack, cerebral thrombosis or cerebral embolism.

  3. The rate of stroke [ Time Frame: 2,3,4,5 years postoperative follow-up ]
    Stroke is deviated into ischemic, hemorrhagic or undetermined stroke, and transient ischemic attacks (TIA).

  4. The event of bleeding [ Time Frame: 2,3,4,5 years postoperative follow-up ]
    Intracranial or alimentary canal, or any bleeding that requires transfusion of 2 units of red blood cell suspension.

  5. Cardiac events [ Time Frame: 2,3,4,5 years postoperative follow-up ]
    Non-fatal myocardial infarction, arrhythmia, cardiac tamponade, cardiogenic shock, endocarditis.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who participated in the LAmbreTM Safety and Efficacy Study and completed the 1-year follow-up.
Criteria

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:

  1. Age>=18, CHADS2 score>=1
  2. Patients cannot be treated long-term with Warfarin
  3. Eligible for clopidogrel and aspirin
  4. 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:

  1. Need to take Warfarin
  2. Presence of rheumatic, degenerative or congenital valvular heart diseases
  3. Early stage or paroxysmal atrial fibrillation
  4. Symptomatic patients with carotid artery disease (such as carotid stenosis>=50%)
  5. Heart failure NYHA grade IV
  6. Recent 30 days stroke or TIA
  7. Presence of active sepsis or endocarditis
  8. Cardiac tumours or other malignancy with estimated life expectancy <2 years
  9. Abnormal blood test; renal dysfunction
  10. LAA removed or heart implant patients
  11. Patients have planned electrophysiological ablation or cardioversion 30 days post implantation of the LAmbre system
  12. Patients have a history of mechanical prosthesis operation
  13. Patients who are pregnant, or desire to be pregnant during the during the study
  14. Participation in other trials
  15. A known allergy to nitinol
  16. Patients will not be able to complete the trial
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03693092


Contacts
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Contact: Ying Xia +86 13760184511 xiaying@lifetechmed.com

Locations
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China, Beijing
Beijing Chaoyang Hospital, Capital Medical university
Beijing, Beijing, China
Fuwai Hospital Chinese Academy of Medical Science
Beijing, Beijing, China
Contact: Yan Yao         
China, Heilongjiang
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Contact: Bo Yu         
China, Hubei
People's Hospital of Wuhan University
Wuhan, Hubei, China
Contact: Congxin Huang         
Wuhan Asia Heart Hospital
Wuhan, Hubei, China
Contact: Xi Su         
China, Jiangsu
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Contact: Minglong Chen         
China, Liaoning
The General Hospital of Shenyang Military Region
Shenyang, Liaoning, China
Contact: Zulu Wang         
China, Shandong
The First Affiliated Hospital of Dalian Medical University
Dalian, Shandong, China
Contact: Yanzong Yang         
China, Shanghai
Shanghai Tenth People's Hospital
Shanghai, Shanghai, China
Contact: Yawei Xu         
Xinhua Hospital Affiliated Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai, China
Contact: Yigang Li         
China
West China Hospital, Sichuan University
Chengdu, China
Contact: Jian Jiang         
Sponsors and Collaborators
Lifetech Scientific (Shenzhen) Co., Ltd.
Investigators
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Principal Investigator: Congxin Huang People's Hospital of Wuhan University
More Information
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Additional Information:

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Responsible Party: Lifetech Scientific (Shenzhen) Co., Ltd.
ClinicalTrials.gov Identifier: NCT03693092    
Other Study ID Numbers: LAA 2-5ys FU
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes