층류 LAAX 핵심 IDE 연구
층류 좌심방 부속물 제거(LAAX) 핵심 IDE 연구
The purpose of this study is to compare the safety and effectiveness of Laminar Left Atrial Appendage Closure (LAAC) device as compared to the commercially available LAAC devices in participants with non-valvular atrial fibrillation (NVAF) to reduce the risk of stroke (blocked blood vessel or bleeding in brain) and systemic embolism (blockage in a blood vessel harming vital organs).
연구 개요
상태
정황
상세 설명
This prospective, randomized, controlled, multicenter, open-label pivotal clinical study will enroll participants with non-valvular atrial fibrillation who are eligible for short-term anticoagulation therapy but have a rationale to seek non-pharmacologic alternative. Participants will be randomized 1:1 to the Laminar Left Atrial Appendage Closure System or commercially available device (WATCHMAN™ left atrial appendage closure device / Amulet™ left atrial appendage occluder).
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35243
- Grandview Medical Center
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Arizona
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Phoenix, Arizona, 미국, 85018
- Arizona Arrhythmia Research Group Phoenix Cardio Research Group PCRG
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Tucson, Arizona, 미국, 85712
- Tucson Medical Center
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Arkansas
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Jonesboro, Arkansas, 미국, 72401
- Arrhythmia Research Group
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California
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Los Angeles, California, 미국, 90048
- Cedars Sinai Medical Center
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Palo Alto, California, 미국, 94303
- Stanford Health Care
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Rancho Cordova, California, 미국, 95670
- Univeristy of California Davis Health
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San Diego, California, 미국, 92121
- Scripps Health
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Santa Monica, California, 미국, 90404
- Providence Saint John's Health Center and the Pacific Heart Institute
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Thousand Oaks, California, 미국, 91360
- Los Robles Regional Medical Center
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Florida
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North Naples, Florida, 미국, 34102
- NCH Healthcare
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Sarasota, Florida, 미국, 34239
- Sarasota Memorial Hospital
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Georgia
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Atlanta, Georgia, 미국, 30322
- Emory University
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Atlanta, Georgia, 미국, 30309
- Piedmont Healthcare
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Savannah, Georgia, 미국, 31404
- Memorial Health University Medical Center
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Kansas
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Overland Park, Kansas, 미국, 66211
- The Kansas City Heart Rhythm Institute
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Wichita, Kansas, 미국, 67214
- Ascension via Christi Hospitals Wichita Inc
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Kentucky
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Lexington, Kentucky, 미국, 40503
- Baptist Health Lexington
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Massachusetts
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Boston, Massachusetts, 미국, 02114
- Massachusetts General Hospital
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New York
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Bay Shore, New York, 미국, 11706
- Northwell Health
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New York, New York, 미국, 10029
- Icahn School of Medicine at Mount Sinai
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New York, New York, 미국, 10016
- NYU Langone Health
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New York, New York, 미국, 10032
- Columbia University in the City of New York and The New York and Presbyterian Hospital
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The Bronx, New York, 미국, 10467
- Montefiore Medical Center
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North Carolina
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Charlotte, North Carolina, 미국, 28203
- Wake Forest University Health Sciences
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Ohio
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Cincinnati, Ohio, 미국, 45219
- Lindner Clinical Trial Center/Christ Hospital
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Cincinnati, Ohio, 미국, 45202
- Bethesda North Hospital Trihealth
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Columbus, Ohio, 미국, 43210
- Ohio State University
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Columbus, Ohio, 미국, 43214
- Ohio Health
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South Carolina
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North Charleston, South Carolina, 미국, 29406
- Trident Medical Center
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Tennessee
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Nashville, Tennessee, 미국, 37232
- Vanderbilt University Medical Center
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Nashville, Tennessee, 미국, 37203
- Centennial Medical Center
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Texas
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Austin, Texas, 미국, 78705
- Texas Cardiac Arrhythmia Research Foundation
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Shenandoah, Texas, 미국, 77380
- Heart Rhythm Associates
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Washington
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Seattle, Washington, 미국, 98122
- Swedish Medical Center
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Tacoma, Washington, 미국, 98405
- St Joseph Hospital and Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Documented evidence of paroxysmal, persistent, or permanent non-valvular atrial fibrillation (NVAF)
- CHA2DS2-VASc score greater than or equal to (>=) 2 in men and >= 3 in women
- Deemed to be clinically indicated for left atrial appendage (LAA) closure by the Site Investigator and a clinician not a part of the procedural team using an evidence-based decision-making tool in accordance with standard of care
- Recommended for chronic oral anticoagulation therapy (OAC) but has an appropriate rationale to seek a non-pharmacologic alternative
- Eligible for the protocol-specified post-procedural antithrombotic regimen
- Willing and able to comply with the protocol, and has provided written informed consent (participant or legally authorized representative) per institutional review board (IRB) requirements
Exclusion Criteria:
- Single episode, transient, or reversible atrial fibrillation (AF) (example, secondary to thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
- Prior cardiac surgery or any procedure that involved pericardial access
- Stage IV kidney disease or Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) less than (<) 30 milliliters per minute per (mL/min)/1.73 square meters (m^2) or participants with end stage renal disease who are dialysis dependent
- Any cardiac or non-cardiac interventional or surgical procedures within 60 days prior to or any planned general surgery, cardiac surgery, or interventional procedure within 60 days after implant (including, but not limited to cardioversion, percutaneous coronary intervention (PCI), cardiac ablation, cataract surgery)
- Left atrial appendage anatomy which cannot accommodate either commercially available control device or the laminar implant per manufacturer instructions for use (IFU) (that is, the anatomy and sizing must be appropriate for a control and the Laminar device to be enrolled in the study)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Laminar Device
Participants will be treated with the Laminar Left Atrial Appendage Closure System. |
Treatment with the Laminar Left Atrial Appendage Closure System. |
|
활성 비교기: Control left atrial appendage closure (LAAC)
Participants will be treated with a commercially-available LAAC device. |
Treatment with a WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
All-Cause Mortality
기간: Up to 12 months
|
Composite rate of all-cause mortality will be reported. |
Up to 12 months
|
|
Number of Participants With Major Bleeding According to the Bleeding Academic Research Consortium (BARC) Type III or V
기간: Up to 12 months
|
The number of participants with major bleeding, according to the BARC type III or V, will be reported. Type III
Type V
|
Up to 12 months
|
|
Number of Participants With Pericardial Effusion Requiring Drainage
기간: Up to 12 months
|
Participants with pericardial effusion requiring drainage will be reported. Pericardial effusion is defined as 1) Clinically non-relevant: requiring no intervention, treated pharmacologically and 2) Clinically relevant: treated with therapeutic intervention (pericardiocentesis, surgical intervention, blood transfusion) and/or result in shock or death. |
Up to 12 months
|
|
Number of Participants With Device Embolization
기간: Up to 12 months
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Participants with device embolization will be reported. Device embolization is defined as movement of a medical device to an unintended location within the body with resulting obstruction of an organ or vessel. |
Up to 12 months
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Number of Participants With Device or Procedure-Related Events Requiring Open Cardiac Surgery or Major Endovascular Intervention
기간: Up to 12 Months
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Participants with device or procedure-related events requiring open cardiac surgery or major endovascular intervention will be reported. |
Up to 12 Months
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Number of Participants Reporting Ischemic Stroke or Systemic Embolism
기간: Up to 18 Months
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Participant reporting ischemic stroke or systemic embolism will be reported. Systemic embolism is defined as acute vascular insufficiency or occlusion of the extremities or any non-CNS organ associated with clinical, imaging, surgical/autopsy evidence of arterial occlusion in the absence of other likely mechanism (example; trauma, atherosclerosis, or instrumentation). |
Up to 18 Months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants With Peri-Device Flow
기간: Up to 12 Months
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Peri-Device flow is defined as >= 3 mm in width which communicates beyond the device into the body of the left atrial appendage) per transesophageal echocardiogram (TEE) evaluated by independent core laboratory. |
Up to 12 Months
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Rate of Device-Related Thrombosis
기간: Up to 12 Months
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Device related thrombosis is defined as density attached to the implanted LAAC device in echocardiographic or computer tomography imaging. |
Up to 12 Months
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Saibal Kar, MD, Los Robles Health System
- 수석 연구원: Devi Nair, MD, St. Bernards Heart and Vascular Center
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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