Clinical trial NCT03666780: Lifetech LAmbre™ Left Atrial Appendage (LAA) Closure System Post-Market Clinical Follow-up Study
Official title: Lifetech LAmbre™ Left Atrial Appendage (LAA) Closure System Post-Market Clinical Follow-up: MULTI-CENTER, SINGLE-ARM, PROSPECTIVE, POST-MARKET STUDY
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atrial Fibrillation
Keywords: Left Atrial Appendage Occluder
LAmbre
Lifetech LAA
Lifetech LAmbre
LT LAA
Left Atrial Appendage
Lead sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: IQVIA Biotech
First posted: 2018-09-12
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with non-valvular paroxysmal, persistent, or permanent atrial fibrillation with long-term sustainability are scheduled for interventional LAA closure.

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

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 Scores 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) are 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 who 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.

LAmbre™ 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. LAmbre™ LAA Closure System received the CE mark in June 2016.

This PMCF study will be carried out following the CE mark of the LAmbre™ LAA Closure System and is intended to confirm the effectiveness and safety of the LAmbre™ LAA Closure System.

Eligibility 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\*;

   * Note: Choose a device that is 3-8mm larger than the landing zone diameter.
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 the requirements of the study including the 3-year follow-up.

Warning: The device sizing is based on angiographic measurements.

Exclusion Criteria:

1. Any contra-indication mentioned in the corresponding IFU\*;

   * Note: In IFU, the Left Atrial Appendage Closure System is contraindicated for the following:

     1. Patients' LAA anatomy is not suitable for the REF of the device.
     2. Patients with intracardiac thrombus.
     3. Patients with active endocarditis or other infections causing bacteremia.
     4. Patients where the placement of the device would interfere with any intracardiac or intravascular structures.
     5. Patients with contraindications to X-ray and/or trans-esophageal echocardiographic examinations.
     6. Patients with known hypersensitivity to nickel.
2. Currently participating in other investigational drug- or device studies;
3. Patient who is pregnant, planning to become pregnant or breastfeeding;
4. Patients cannot tolerate transoesophageal echocardiogram (TEE).

Primary outcomes:
measure: 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);
timeFrame: Within 7 days post-procedure.
measure: Implant success.
timeFrame: At procedure.
Secondary outcomes:
measure: Incidence of stroke or systemic embolism or death through 3 years post-implantation.
timeFrame: From attempted procedure to 3 years post-implantation
measure: 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.
timeFrame: 1-3 months, 6 months post-implantation
measure: Device or procedure-related Serious Adverse Events (SAEs) from attempted procedure through 3 years post-implantation
timeFrame: From attempted procedure to 3 years post-implantation
measure: All SAEs (death included) from attempted procedure through 3 years post-implantation.
timeFrame: From attempted procedure to 3 years post-implantation
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: 1001 - HKU Queen Mary Hospital
city: Aarhus
country: Denmark
facility: 201 - Aarhus Universitetshospital
city: Berlin
country: Germany
facility: 104 - Charité Campus Benjamin Franklin (CBF)
city: Berlin
country: Germany
facility: 107 - Charité Campus Virchow-Klinikum
city: Bonn
country: Germany
facility: 105 - UKB Universitätsklinikum Bonn
city: Coburg
country: Germany
facility: 111 - Klinikum Coburg GmbH
city: Dresden
country: Germany
facility: 114 - Facharztzentrum Dresden-Neustadt GbR
city: Essen
country: Germany
facility: 102 - Alfried Krupp Hospital Ruettenscheid
city: Frankfurt
country: Germany
facility: 101 - CVC CardioVasculäres Centrum Frankfurt
city: Frankfurt
country: Germany
facility: 109 - Cardioangiologisches Centrum Bethanien (CCB)
city: Jena
country: Germany
facility: 108 - Universitätsklinikum Jena
city: Leipzig
country: Germany
facility: 103 - Klinikum St. Georg gGmbH
city: Leipzig
country: Germany
facility: 110 - Herzzentrum Leipzig (HZL)
city: Mainz
country: Germany
facility: 113 - Universitätsmedizin der Johannes Gutenberg-Universität Mainz
city: München
country: Germany
facility: 106 - Peter Osypka Herzzentrum
city: Dublin
country: Ireland
facility: 301 - Mater Misericordiae University Hospital
city: Milan
country: Italy
facility: 401 - Centro Cardiologico Monzino
city: Milan
country: Italy
facility: 403 - ASST Grande Ospedale Metropolitano Niguarda
city: Napoli
country: Italy
facility: 406 - Clinica Mediterranea S.P.A./Clinica Mediterranea - Ospedale e Centro Diagnostico
city: Roma
country: Italy
facility: 405 - La Struttura ASL Roma 2
city: Łódź
country: Poland
facility: 501 - Wojewódzki Specjalistyczny Szpital im. dr. Wł. Biegańskiego
city: Barcelona
country: Spain
facility: 603 - FundacióInstitut Hospital del Mar d'Investigacions Mèdiques (IMIM)
city: Barcelona
country: Spain
facility: 602 - Hospital Clínic de Barcelona
city: Salamanca
country: Spain
facility: 601 - University Hospital of Salamanca/Hospital Clínico Universitario de Salamanca
city: Göteborg
country: Sweden
facility: 801 - Sahlgrenska Universitetssjukhuset/Sahlgrenska University Hospital
city: Bangkok
country: Thailand
facility: 901 - Faculty of Medicine Ramathibodi Hospital, Mahidol University
Study officials:
affiliation: CVC CardioVasculäres Centrum Frankfurt
name: Horst Sievert, Prof
role: PRINCIPAL_INVESTIGATOR
References: