Lifetech LAmbre™ Left Atrial Appendage (LAA) Closure System Post-Market Clinical Follow-up
Study Details
Study Description
Brief Summary
Multi-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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Atrial fibrillation (AF) is the most common cardiac arrhythmia causing ischemic stroke. The CHA2DS2-VASc score was developed to estimate the stroke rate in patients with non-valvular AF, and high scores predict a raised annual stroke risk. The yearly stroke risks without treatment in patients with CHA2DS2-VASc score 2 and 9 are 2.2% and 15.2% respectively. For patients with increased stroke risk (CHA2DS2-VASc score ≧2), warfarin or other novel oral anticoagulants (NOAC) recommended for stroke prevention. Despite the effectiveness of current pharmacological therapies for stroke prevention in atrial fibrillation, around 20% of patients discontinue therapy - whether new oral anticoagulants (NOAC) or warfarin because of side effects and/or bleeding. In addition, warfarin needs to be dosed individually to target an international normalized ratio (INR) of 2-3 for striking an optimal balance between bleeding and ischemic stroke events. This, combined with drug-drug interaction that occurs with both NOACs and warfarin, results in inadequate stroke protection in a substantial portion of AF patients. The LAA is the source of 90% of cardiac emboli attributed to stroke events. This is a windsock-like structure on the lateral border of the left atrium with internal trabeculations, and being a confined space, is prone to blood stasis and thrombus formation. Currently, there are surgical, epicardial and percutaneous techniques for occluding this structure in order to reduce stroke in AF patients cannot take long term oral anticoagulants, and the percutaneous route is intuitively the most attractive given its relative non-invasiveness. The two devices in most widespread use for percutaneous LAA closure worldwide are the Watchman (Boston Scientific, Natick, MA, USA) and the Amplatzer Cardiac Plug (ACP) (Abbott, IL, CA USA). However, both devices have limitations including the need for relatively large delivery sheaths (9-14 French) and limited recapture and repositioning capabilities.
LAmbreTM LAA Closure System (Lifetech Scientific, Shenzhen, China) is a novel self-expanding LAA occluder constructed from a nitinol mesh and polyester membranes and consists of an umbrella and a cover connected by a short central waist. The device is delivered by an 8-10 French sheath and has full recapture and repositioning capabilities. LAmbreTM LAA Closure System received the CE mark in June 2016.
This PMCF study will be carried out following the CE mark of LAmbreTM LAA Closure System and is intended to confirm effectiveness and safety of LAmbreTM LAA Closure System.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Subject All patients who signed informed consent and are implanted with a LAmbre occluder device will undergo follow-up (FU) evaluations as per local hospital standard and corresponding IFU which is expected to be at the following time points post implant: At discharge (+/- 1 day) 1-3 months (+/- 1 week) 6 months (+/- 2 weeks) 12 months (+/- 1 month) 2 years (+/- 3 month) 3 years(+/- 3 month) Patients who have undergone a LAmbre explant should remain in the study and adhere to the above mentioned follow-up time point until completion of 3 years follow-up period. After the patient has completed the 3 years follow-up assessments, the patient is considered to have completed the study. A study exit eCRF needs to be completed and the patient will receive routine care. |
Device: LAmbre occluder
All patients are implanted with a LAmbre occluder device
|
Outcome Measures
Primary Outcome Measures
- 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); [7 days]
Peri-procedure defined as within 7 days of the procedure.
- Implant success [1 day]
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)
Secondary Outcome Measures
- Incidence of stroke or systemic embolism or death through 3 years post implantation [3 years]
Incidence of stroke or systemic embolism or death through 3 years post
- 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]
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
- Device or procedure related Serious Adverse Events (SAEs) from attempted procedure through 3 years post implantation [3 years]
Device or procedure related Serious Adverse Events (SAEs) from attempted procedure through 3 years post implantation
- All SAEs (death included) from attempted procedure through 3 years post implantation [3 years]
All SAEs (death included) from attempted procedure through 3 years post implantation
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients must be at least 18 years of age;
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Patients with non-valvular paroxymal, persistent or permanent atrial fibrillation with long-term sustainability scheduled for interventional LAA closure;
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Patient characteristics consistent with the corresponding IFU and sizing guidelines;
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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);
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The patient agrees to comply with requirements of the study including the 3 year follow-up.
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Exclusion Criteria:
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Any contra-indication mentioned in the corresponding IFU;
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Currently participating in other investigational drug- or device studies;
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Patient who is pregnant, planning to become pregnant or breast feeding;
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Patients cannot tolerate transoesophageal echocardiogram (TEE).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Aarhus University Hospital | Aarhus | Denmark | ||
| 2 | Campus Benjamin Franklin (CBF) | Berlin | Germany | ||
| 3 | Charité Campus Virchow-Klinikum | Berlin | Germany | ||
| 4 | Universitätsklinikum Bonn | Bonn | Germany | ||
| 5 | Klinikum Coburg | Coburg | Germany | ||
| 6 | Facharztzentrum Dresden-Neustadt GbR | Dresden | Germany | ||
| 7 | Krupp Krankenhaus Essen | Essen | Germany | ||
| 8 | Cardioangiologisches Centrum Bethanien | Frankfurt | Germany | ||
| 9 | CardioVasculäres Centrum Frankfurt | Frankfurt | Germany | ||
| 10 | Universitätsklinikum Jena | Jena | Germany | ||
| 11 | Herzzentrum Leipzig | Leipzig | Germany | ||
| 12 | Klinikum St. Georg gGmbH | Leipzig | Germany | ||
| 13 | Universitätsmedizin der Johannes Gutenberg-Universität Mainz | Mainz | Germany | ||
| 14 | Peter Osypka Herzzentrum | Munich | Germany | ||
| 15 | Queen Mary Hospital | Hong Kong | Hong Kong | ||
| 16 | Mater Private Hospital | Dublin | Ireland | ||
| 17 | ASST Grande Ospedale Metropolitano Niguarda | Milan | Italy | ||
| 18 | Centro Cardiologico Monzino | Milan | Italy | ||
| 19 | Clinica Mediterranea S.P.A. | Napoli | Italy | ||
| 20 | La Struttura ASL Roma 2 | Roma | Italy | ||
| 21 | Wojewódzki Specjalistyczny Szpital im. dr. Wł. Biegańskiego | Łódź | Poland | ||
| 22 | FundacióInstitut Hospital del Mar d'Investigacions Mèdiques | Barcelona | Spain | ||
| 23 | Hospital Clínic de Barcelona | Barcelona | Spain | ||
| 24 | University Hospital of Salamanca | Salamanca | Spain | ||
| 25 | Sahlgrenska Universitetssjukhuset | Göteborg | Sweden | ||
| 26 | Ramathibodi Hospital | Bangkok | Thailand |
Sponsors and Collaborators
- Lifetech Scientific (Shenzhen) Co., Ltd.
Investigators
- Principal Investigator: Horst Sievert, Professor, Cardiovascular Center Frankfurt
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LA-PMCF-01