Using Left Atrium Appendage Closure in NVAF Patients With High Risk of Ischemic Stroke

NCT04479722 | Active Not Recruiting

• 1 other identifier: SAFE-PROTECT
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and efficacy of using Microport CardioAdvance Left Atrium Appendage Closure for preventing stroke in Non-valvular atrial fibrillation (NVAF) patients who have contraindications for long-term anti-coagulation. And to support registration approval from National Medical Products Administration (NMPA).

Conditions

Atrial Fibrillation; Stroke

Keywords

LAAC; NVAF; ischemic stroke

Outcome Measures

Primary Outcomes (1)

• Clinical success

  Freedom from ischemic stroke, hemorrhagic stroke, systemic embolism, cardiovascular death and unexplained death

  12-month

Secondary Outcomes (1)

• LAA occlusion success

  12-month

Study Arms (2)

Microport CardioAdvance LAAC system

EXPERIMENTAL

Subject implant Microport CardioAdvance LAAC system to occlude LAA through percutaneous intervention.

Device: Left atrial appendage closure procedure

Watchman LAAC system

ACTIVE COMPARATOR

Subject implant Watchman LAAC system to occlude LAA through percutaneous intervention.

Device: Left atrial appendage closure procedure

Interventions

Left atrial appendage closure procedure DEVICE

Implant LAAC system in LAA through percutaneous intervention

Microport CardioAdvance LAAC system; Watchman LAAC system

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non valvular atrial fibrillation subjects aged ≥18 and ≤80;
• High risk of ischemic stroke: CHA2DS2VASc score ≥ 2 ( ≥ 3 for female) together with any of the following circumstances:
• With a recorded history (happened earlier than 6 months from now) of bleeding (including gingival/nasal/oral bleeding, skin \&soft tissue bleeding, gastrointestinal bleeding, urinary tract bleeding, cerebral haemorrhage, etc.) or bleeding tendency;
• Intolerance or rejection of long-term anti-coagulation therapy;
• Suffering stroke or embolism despite routine anti-coagulation therapy;
• With a predicting HAS-BLED score ≥3.
• Subjects (or his/her legal representatives) are able to understand the study objectives, willing to cooperate with procedure and follow-up. Subjects who voluntarily participate in this trial and have signed the written informed consent form.

You may not qualify if:

• Subjects with atrial fibrillation (AF) caused by rheumatic valvular disease, moderate to severe mitral stenosis, severe mitral regurgitation, severe aortic valve disease or severe left ventricular outflow tract obstruction with pressure difference greater than 40mmHg;
• Suffering with other disease(s) requiring long-term oral anticoagulation treatment;
• Initial untreated AF, or secondary AF with clear cause (such as hyperthyroid heart disease);
• Intracardiac thrombus (including left and/or right atrium) found or persisted;
• Suffered with myocardial infarction within 3 months;
• History of previous atrial septum repair operation or Atrial Septal Occluder implantation;
• History of previous heart valve (mechanical valve) replacement operation;
• Subjects undergoing heart transplant operation;
• Subjects with symptomatic carotid artery disease (such as carotid stenosis \> 50%) or subjects with vulnerable carotid artery plaque.
• Suffered with ischemic stroke or TIA recently (within 30 days);
• Known complex active atherosclerotic plaque(s) in the descending aorta or aortic arch;
• Severe heart failure (NYHA Grade Ⅳ);
• The investigator assessed that there were abnormal result(s) with clinical significance in the routine blood test of subjects；
• Severe renal abnormal: serum creatinine \>250μmol/l; or on dialysis;
• Allergic or contraindicated to aspirin, clopidogrel, heparin, contrast agent, and nitinol alloy;

Sponsors & Collaborators

• Shanghai MicroPort Medical (Group) Co., Ltd.: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Atrial Fibrillation; Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Ming Zheng, Prof.

  MicroPort Orthopedics Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 21, 2020
• Study Start: March 3, 2021
• Primary Completion: September 27, 2022
• Study Completion (Estimated): September 30, 2026
• Last Updated: October 23, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: For the beginning 3 months and ending 5 years following article publication
• Access Criteria: (with) Researchers who provide a methodologically sound proposal. (For the analysis) To achieve aims in the approved proposal. (Requisite mechanism) Proposals should be directed to mzheng@microport.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link to be included).

Locations

CN (1)