Lifetech LAmbre™ Left Atrial Appendage Closure System Post-Market Registry

NCT04307927 | Unknown

• 1 other identifier: LA-PMCF-02
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Single-center, single-arm, prospective, post-market study of LAmbre™ LAA Closure System. To evaluate immediate and long term procedural success of Lifetech LAmbre™ occluders in patients.

Conditions

Atrial Fibrillation

Keywords

Left atrial appendage occluder

Outcome Measures

Primary Outcomes (2)

• 1.Absence of peri-procedural stroke/TIA, device embolization, cardiac or vascular perforation, any other device or procedure related serious adverse event or death (procedure or device related or of unknown cause);

  Peri-procedure defined as within 7 days of the procedure.

  7 days

• Implant success

  Implant success defined as correct positioning and release of the occluder device into the proper anatomical location. Correct positioning is assessed as absence of major residual jet flow (\>5mm) into the LAA closure with the device evaluated by transesophageal echocardiogram (TEE).

  1 day

Secondary Outcomes (5)

• Incidence of stroke or systemic embolism or death through 24 months post implantation

  24 months

• Successful sealing around the device at the LAA orifice with residual jet ≤5 mm flow measured by TEE at 1-3 months, 6 months post-implantation

  1-3 months, 6 months post-implantation

• Device or procedure related Serious Adverse Events (SAEs) from attempted procedure through 24 months post implantation

  24 months

• All SAEs (death included) from attempted procedure through 24 months post implantation

  24 months

• Incidence of bleeding event through 24 months post implantation.

  24 months

Eligibility Criteria

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

Study Population

Patients with non-valvular paroxymal, persistent or permanent atrial fibrillation with long-term sustainability scheduled for interventional LAA closure.

You may qualify if:

• \. Patients must be at least 18 years of age; 2. Patients with non-valvular paroxysmal, persistent or permanent atrial fibrillation with long-term sustainability scheduled for interventional LAA closure; 3. Patient characteristics consistent with the corresponding IFU and sizing guidelines\*; 4. The patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the appropriate Ethics Committee (EC); 5. The patient agrees to comply with requirements of the study including the 24 months follow- up.

You may not qualify if:

• \. Any contra-indication mentioned in the corresponding IFU\*; 2. Currently participating in other investigational drug- or device studies; 3. Patient who is pregnant, planning to become pregnant, or breast feeding; 4. Patients cannot tolerate transoesophageal echocardiogram (TEE).
• Note: In IFU, the Left Atrial Appendage Closure System is contraindicated for the following: • Patients' LAA anatomy not suitable for the REF of the device.
• Patients' with intracardiac thrombus.
• Patients with active endocarditis or other infections causing bacteremia.
• Patients where placement of the device would interfere with any intracardiac or intravascular structures.
• Patients with contraindications to X-Ray and/or trans-esophageal echocardiographic examinations.
• Patients with known hypersensitivity to nickel.

Sponsors & Collaborators

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

Study Sites (1)

Katholisches Klinikum Koblenz ·Montabaur

Koblenz, 56073, Germany

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jiangtao Yu, Professor

  Katholisches Klinikum Koblenz ·Montabaur

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yun Li

CONTACT

+86 13534247025; liyun@lifetechmed.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: March 13, 2020
• Study Start: March 14, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: November 29, 2022

Record last verified: 2022-11

Locations

DE (1)