Study of Safety and Efficacy of a Left Atrial Appendage Occulder
Primary Purpose
Non-valvular Atrial Fibrillation, Stroke
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
The Left Atrial Appendage Occulder of Shanghai Push Medical Device Technology CO.td
Sponsored by
About this trial
This is an interventional treatment trial for Non-valvular Atrial Fibrillation focused on measuring Nonvalvular atrial fibrillation, Stroke, Left Atrial Appendage Closure, Intervention
Eligibility Criteria
Inclusion Criteria:
- Patient is ≥18 years of age;
- Chronic atrial fibrillation ≥3 months; paroxysmal, persistent or permanent non-valvular AF;
- CHADS2-VAS score 2 or higher,HAS-BLED score 3 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.
Exclusion Criteria:
- A. Clinical exclusion criteria: 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; Have thrombocytopenia (platelet 《105 / μl) or anemia(Hb<10g/dl); Women who is pregnancy or plan to pregnancy during the trial period; Presence of active sepsis or endocarditis; Patient participated in the other trials; The investigators expect the patient not be able to complete the trial according to requirements.
- Esophageal ultrasonic exclusion criteria: LVEF≤30%; Presence of left atrial appendage thrombus; High risk PFO patients(presence of atrial septal aneurysm); Have obvious mitral valve stenosis (the area of mitral valve≤ 2 cm2); Have obvious and unexplained pericardial effusion(≥4 cm2). Presence of complex aortic plague(≥4 mm) in ascending aorta.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Left Atrial Appendage Closure Device Group
Arm Description
Device:LAmbre Left Atrial Appendage Occluder(Shanghai Push Medical Device Technology CO.td) to close the left atrial appendage
Outcomes
Primary Outcome Measures
Ischemic stroke
Successful sealing of the LAA
TEE Criteria
Secondary Outcome Measures
Component events
death, thromboembolism, device related complication and MACCE
Complication at puncture site
Device performance assessed by TEE/TTE
Full Information
NCT ID
NCT02937025
First Posted
October 14, 2016
Last Updated
October 14, 2016
Sponsor
Ya-Wei Xu
Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shenyang Military Region General Hospital of People's Liberation Army, West China Hospital, Ruijin Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Zhejiang Provincial People's Hospital, Fujian Medical University Union Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02937025
Brief Title
Study of Safety and Efficacy of a Left Atrial Appendage Occulder
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
January 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ya-Wei Xu
Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shenyang Military Region General Hospital of People's Liberation Army, West China Hospital, Ruijin Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Zhejiang Provincial People's Hospital, Fujian Medical University Union Hospital
4. Oversight
5. Study Description
Brief Summary
This study mainly evaluated the feasibility and safety of a kind of Left Atrial Appendage Occluders which is to prevent ischemic stroke caused by nonvalvular atrial fibrillation (AF)
Detailed Description
Atrial fibrillation (AF) is a common arrhythmia, its incidence increases with age. Thrombosis shed off caused by AF is one of the major causes of stroke. Most patients with AF suffer ischemic stroke that the thrombosis was from the left atrial appendage(LAA). The majority of patients with atrial fibrillation, the blood clots come from the left atrial appendage, so close the left atrial appendage can reduce cycle thromboembolism of the patients with AF. Now patients have cardiac surgery and risk at left atrium related thromboembolism, the surgery has been conventional perform the left atrial appendage closed surgery.
However, surgical left atrial appendage ligation is difficult to be completely closed to the left atrial appendage,internal medicine intervention methods of surgical closure the left atrial appendage is relatively simple, minimally invasive, high success rate and is expected to be widely used.
Several versions of LAA occlusion devices have been developed.LAA occluder of Shanghai Push Medical Device Technology CO.td, consists of a fixed ball and a cover; The fixed ball composed of multiple umbrella and covered the ePTFE membrane.This study mainly evaluated the feasibility and safety of the new Left Atrial Appendage Occluder! Through the femoral vein puncture; insert inter atrial septum puncture device; puncture a small hole in the atrial septal, delivery sheath is inserted in the femoral vein puncture site and across the atrial septal reach the left atrial appendage, establishment of the channel. Through the built-channel sent the LAA occluder to the left atrial appendage by the delivery cable; The LAA occlude will be fixed in the left atrial appendage, close the entrance of the left atrial appendage meanwhile and block blood flow; then eliminate the risk of blood clots due to atrial fibrillation, prevention stroke.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-valvular Atrial Fibrillation, Stroke
Keywords
Nonvalvular atrial fibrillation, Stroke, Left Atrial Appendage Closure, Intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
154 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Left Atrial Appendage Closure Device Group
Arm Type
Experimental
Arm Description
Device:LAmbre Left Atrial Appendage Occluder(Shanghai Push Medical Device Technology CO.td) to close the left atrial appendage
Intervention Type
Device
Intervention Name(s)
The Left Atrial Appendage Occulder of Shanghai Push Medical Device Technology CO.td
Intervention Description
Implanting the Occluder to close the left atrial appendage
Primary Outcome Measure Information:
Title
Ischemic stroke
Time Frame
12 months
Title
Successful sealing of the LAA
Description
TEE Criteria
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Component events
Description
death, thromboembolism, device related complication and MACCE
Time Frame
12 months
Title
Complication at puncture site
Time Frame
12 months
Title
Device performance assessed by TEE/TTE
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is ≥18 years of age;
Chronic atrial fibrillation ≥3 months; paroxysmal, persistent or permanent non-valvular AF;
CHADS2-VAS score 2 or higher,HAS-BLED score 3 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.
Exclusion Criteria:
A. Clinical exclusion criteria: 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; Have thrombocytopenia (platelet 《105 / μl) or anemia(Hb<10g/dl); Women who is pregnancy or plan to pregnancy during the trial period; Presence of active sepsis or endocarditis; Patient participated in the other trials; The investigators expect the patient not be able to complete the trial according to requirements.
Esophageal ultrasonic exclusion criteria: LVEF≤30%; Presence of left atrial appendage thrombus; High risk PFO patients(presence of atrial septal aneurysm); Have obvious mitral valve stenosis (the area of mitral valve≤ 2 cm2); Have obvious and unexplained pericardial effusion(≥4 cm2). Presence of complex aortic plague(≥4 mm) in ascending aorta.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuang Li, MD
Phone
086-15921799351
Email
1210874@tongji.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Chen, MD, PHD
Phone
086-21-66308182
Email
18917684083@189.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yawei Xu, MD, PHD
Organizational Affiliation
Shanghai 10th People's Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
19683639
Citation
Holmes DR, Reddy VY, Turi ZG, Doshi SK, Sievert H, Buchbinder M, Mullin CM, Sick P; PROTECT AF Investigators. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. Lancet. 2009 Aug 15;374(9689):534-42. doi: 10.1016/S0140-6736(09)61343-X. Erratum In: Lancet. 2009 Nov 7;374(9701):1596.
Results Reference
background
PubMed Identifier
23325525
Citation
Reddy VY, Doshi SK, Sievert H, Buchbinder M, Neuzil P, Huber K, Halperin JL, Holmes D; PROTECT AF Investigators. Percutaneous left atrial appendage closure for stroke prophylaxis in patients with atrial fibrillation: 2.3-Year Follow-up of the PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation) Trial. Circulation. 2013 Feb 12;127(6):720-9. doi: 10.1161/CIRCULATIONAHA.112.114389. Epub 2013 Jan 16.
Results Reference
background
PubMed Identifier
24998121
Citation
Holmes DR Jr, Kar S, Price MJ, Whisenant B, Sievert H, Doshi SK, Huber K, Reddy VY. Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol. 2014 Jul 8;64(1):1-12. doi: 10.1016/j.jacc.2014.04.029. Erratum In: J Am Coll Cardiol. 2014 Sep 16;64(11):1186.
Results Reference
background
PubMed Identifier
25399274
Citation
Reddy VY, Sievert H, Halperin J, Doshi SK, Buchbinder M, Neuzil P, Huber K, Whisenant B, Kar S, Swarup V, Gordon N, Holmes D; PROTECT AF Steering Committee and Investigators. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014 Nov 19;312(19):1988-98. doi: 10.1001/jama.2014.15192. Erratum In: JAMA. 2015 Mar 10;313(10):1061.
Results Reference
result
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Study of Safety and Efficacy of a Left Atrial Appendage Occulder
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