Feasibility and Safety Study of LAmbre Left Atrial Appendage Occluder

NCT01920412 | Completed Early Phase 1 DMC

• 1 other identifier: LA-AP-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study mainly evaluated the feasibility and safety of LAmbre Left Atrial Appendage Occluder which is to prevent ischemic stroke caused by atrial fibrillation(AF).

Conditions

Atrial Fibrillation; Stroke

Keywords

Atrial fibrillation; Thrombosis; Ischemic stroke; Left atrial appendage occluder; Intervention method

Outcome Measures

Primary Outcomes (1)

• The feasibility end-point

  stable device placement in left atrial appendage as assessed by angiography and trans-esophageal(TEE)and successful sealing around the device LAA orifice with the device(jet\<3mm in width) as measured by TEE at 30 days after device implant

  30 days

Secondary Outcomes (1)

• The composite safety and efficacy end-point

  12 months

Study Arms (1)

Left Atrial Appendage Occluder

EXPERIMENTAL

Adopted non-comparative arm on Left Atrial Appendage Occluder.

Device: LAmbre Left Atrial Appendage(LAA) Occluder

Interventions

LAmbre Left Atrial Appendage(LAA) Occluder DEVICE

Implanting the LAmbre Left Atrial Appendage Occluder to close the left atrial appendage

Left Atrial Appendage Occluder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

• Lifetech Scientific (Shenzhen) Co., Ltd.: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Atrial Fibrillation; Stroke; Thrombosis; Ischemic Stroke

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; Embolism and Thrombosis

Study Officials

• Yat-Yin YY Lam, MD

  Prince of Wales Hospital, Shatin, Hong Kong

  PRINCIPAL INVESTIGATOR

• Muhammad Munawar, MD

  Binawaluya Hospital, Indonesia

  PRINCIPAL INVESTIGATOR

• Lan Hieu Nguyen, MD

  Hanoi Heart Hospital, Vietnam

  PRINCIPAL INVESTIGATOR

• Yan Yao, MD

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

• Congxin Huang, MD

  Renmin Hospital of Wuhan University,China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2013
• First Posted: August 12, 2013
• Study Start: October 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: September 1, 2014
• Last Updated: August 7, 2018

Record last verified: 2013-08

Locations

CN (1)