Left Atrial Appendage Closure With the LAmbre

NCT03147391 | Completed

• 1 other identifier: LAmbre in real world
• Study Type: observational
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study was to retrospectively analyse the efficacy and safety of LAA closure using the LAmbre in our center from April 2014 to November 2015.

Conditions

Atrial Fibrillation; Left Atrial Appendage Closure; Stroke

Keywords

Atrial Fibrillation; Left Atrial Appendage Closure; LAmbre device; Stroke

Outcome Measures

Primary Outcomes (1)

• Ischemic stroke

  Ischemic stroke

  up to 5 years

Secondary Outcomes (2)

• The composite safety and efficacy end-points

  up to 5 years

• Successful sealing of the LAA

  up to 5 years

Study Arms (1)

LAA closure with LAmbre

The patients with atrial fibrillation who received left atrial appendage (LAA) closure using the LAmbre device in our center from April 2014 to November 2015.

Device: LAA closure with LAmbre

Interventions

LAA closure with LAmbre DEVICE

Percutaneous Left Atrial Appendage Closure Using the LAmbre Device in Patients With Atrial Fibrillation

LAA closure with LAmbre

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The aim of this retrospective study was to evaluate the long-term follow-up results associated with left atrial appendage closure (LAAC) with the LAmbre (Lifetech Scientific Corp., Shenzhen, China) in patients with nonvalvular atrial fibrillation (NVAF).

You may qualify if:

• Patient is ≥18 years of age;
• Chronic atrial fibrillation ≥3 months; paroxysmal, persistent or permanent non-valvular AF;
• CHADS2-VAS score 2 or higher;
• Patient can understand the trial purpose, voluntarily join this clinical trial with informed consent;
• Patient voluntarily completes the follow-up and follow-up inspection in accordance with the clinical trials process.

You may not qualify if:

• Presence of rheumatic, degenerative or congenital valvular heart diseases,
• The diameter of left atrial ≥65 mm;
• LAA size \< 12mm or \> 30 mm
• Left atrium has been removed;
• Heart transplantation patients;
• Symptomatic patients with carotid artery disease (such as carotid stenosis ≥ 50%);
• Acute myocardial infarction or unstable angina;
• Decompensated heart failure (New York Heart Association functional class III-IV);
• Recent myocardial infarction (\< 3 months);
• Patients with an atrial septal defect or received an atrial septal occluder. The patient has an ablation procedure planned within 30 days of potential LAmbre Occluder implant
• The patient has a planned cardioversion 30 days post implant of the LAmbre Occluder
• Patient who after artificial mechanical heart valve replacement operation;
• Uncontrolled Heart rate ≥ 110 beats / min17) History stroke or TIA within 30 days;
• Presence of complex aortic plaque(4mm) in ascending aorta;
• Cardiac tumors or other malignancy with estimated life expectancy u less than 2 years;

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead
• Lifetech Scientific (Shenzhen) Co., Ltd.: collaborator

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Interventions

Left Atrial Appendage Closure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Catheterization; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• Yawei Xu, MD, PHD

  Shanghai 10th People's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Cardiology, Principal Investigator

Study Record Dates

• First Submitted: April 9, 2017
• First Posted: May 10, 2017
• Study Start: April 14, 2014
• Primary Completion: November 30, 2016
• Study Completion: May 1, 2017
• Last Updated: May 10, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share