Evaluation of Lifetech LAmbre™ device for closing the left atrial appendage
Lifetech LAmbre™ Left Atrial Appendage Closure System Post-Market Registry Single-center, Single-arm, Prospective, Post-market Registry
This study is testing the Lifetech LAmbre™ device to see if it can safely close a part of the heart in patients with atrial fibrillation to help prevent strokes without using blood thinners.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lifetech Scientific (Shenzhen) Co., Ltd. Industry-sponsored |
| Locations | 1 site (Koblenz) |
| Trial ID | NCT04307927 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the Lifetech LAmbre™ Left Atrial Appendage Closure System to assess its immediate and long-term procedural success in patients with atrial fibrillation. It involves a single-center, single-arm approach where eligible patients will undergo the LAA closure procedure and be followed for 24 months. The study aims to provide insights into the effectiveness of this device as an alternative to anticoagulant therapy for stroke prevention in patients with high stroke risk. The study will also evaluate patient compliance and outcomes related to the procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with non-valvular paroxysmal, persistent, or permanent atrial fibrillation who are scheduled for interventional LAA closure.
Not a fit: Patients who are pregnant, breastfeeding, or unable to tolerate transoesophageal echocardiogram will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a safer and more effective alternative to anticoagulant therapy for patients with atrial fibrillation, reducing their risk of stroke.
How similar studies have performed: Other studies have shown success with similar left atrial appendage closure devices, indicating a promising avenue for stroke prevention in atrial fibrillation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 1. 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.
Exclusion Criteria:
* 1. 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.
Where this trial is running
Koblenz
- Katholisches Klinikum Koblenz ·Montabaur — Koblenz, Germany (Recruiting)
Study contacts
- Principal investigator: Jiangtao Yu, Professor — Katholisches Klinikum Koblenz ·Montabaur
- Study coordinator: Yun Li
- Email: liyun@lifetechmed.com
- Phone: +86 13534247025
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.