LAmbre™ Left Atrial Appendage Closure System Follow-Up Study

Atrial Fibrillation Clinical Trial

Official title:

LAmbre™ Left Atrial Appendage Closure System Post-Market 2-5 Years Follow-Up Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03693092
• Other study ID #: LAA 2-5ys FU
• Status: Not yet recruiting
• Start date: November 20, 2018
• Est. completion date: July 2020

Study information

• Verified date: September 2018
• Source: Lifetech Scientific (Shenzhen) Co., Ltd.
• Contact: Ying Xia
• Phone: +86 13760184511
• Email: xiaying[@]lifetechmed.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 156
• Est. completion date: July 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
China	Beijing Chaoyang Hospital, Capital Medical university	Beijing	Beijing
China	Fuwai Hospital Chinese Academy of Medical Science	Beijing	Beijing
China	West China Hospital, Sichuan University	Chengdu
China	The First Affiliated Hospital of Dalian Medical University	Dalian	Shandong
China	The 2nd Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Shanghai Tenth People's Hospital	Shanghai	Shanghai
China	Xinhua Hospital Affiliated Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	The General Hospital of Shenyang Military Region	Shenyang	Liaoning
China	People's Hospital of Wuhan University	Wuhan	Hubei
China	Wuhan Asia Heart Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Lifetech Scientific (Shenzhen) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of compound event	The compound event including death, systemic embolization, complications related to the device and requiring treatment (cardiac embolism, embolization, stroke, hemorrhage, death).	5 years after the surgery
Secondary	The incidence of MACCE events	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.	2,3,4,5 years postoperative follow-up.
Secondary	Ischemic stroke rate	Ischemic stroke is a neurological deficit caused by transient ischemic attack, cerebral thrombosis or cerebral embolism.	2,3,4,5 years postoperative follow-up
Secondary	The rate of stroke	Stroke is deviated into ischemic, hemorrhagic or undetermined stroke, and transient ischemic attacks (TIA).	2,3,4,5 years postoperative follow-up
Secondary	The event of bleeding	Intracranial or alimentary canal, or any bleeding that requires transfusion of 2 units of red blood cell suspension.	2,3,4,5 years postoperative follow-up
Secondary	Cardiac events	Non-fatal myocardial infarction, arrhythmia, cardiac tamponade, cardiogenic shock, endocarditis.	2,3,4,5 years postoperative follow-up