[미국 FDA의 승인 또는 허가를 받지 않은 기기의 시험] (OMNY-AF)
The purpose of this study is to demonstrate the safety and 12-month effectiveness of the BWI OMNYPULSE™ pulsed field ablation (PFA) platform for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF), an irregular heart rate that causes abnormal blood flow.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Arizona
-
Phoenix, Arizona, 미국, 85018
- Phoenix Cardiovascular Research Group
-
-
California
-
Burlingame, California, 미국, 94010
- Mills Peninsula Health Services
-
Larkspur, California, 미국, 94939
- Cardiovascular Associates of Marin
-
Newport Beach, California, 미국, 92663
- Hoag Memorial Hospital
-
San Diego, California, 미국, 92123
- San Diego Cardiac Center
-
-
Colorado
-
Aurora, Colorado, 미국, 80045
- University of Colorado
-
-
Connecticut
-
Hartford, Connecticut, 미국, 06102
- Hartford Hospital
-
-
Florida
-
Jacksonville, Florida, 미국, 32204
- Ascension St. Vincent's
-
Jacksonville, Florida, 미국, 32207
- Baptist Health Research Institute
-
Miami, Florida, 미국, 33133
- HCA Florida Mercy Hospital
-
Naples, Florida, 미국, 34102
- NCH Healthcare
-
Orlando, Florida, 미국, 32803
- Advent Health Orlando
-
-
Georgia
-
Atlanta, Georgia, 미국, 30342
- Emory Saint Joseph's Hospital
-
Atlanta, Georgia, 미국, 30309
- Piedmont Healthcare
-
Atlanta, Georgia, 미국, 30342
- Northside Hospital
-
Savannah, Georgia, 미국, 31404
- Memorial Health University Medical Center
-
-
Illinois
-
Glenview, Illinois, 미국, 60026
- NorthShore University Medical Center
-
-
Maryland
-
Baltimore, Maryland, 미국, 21287
- Johns Hopkins
-
-
Massachusetts
-
Boston, Massachusetts, 미국, 02114
- Massachusetts General
-
Boston, Massachusetts, 미국, 02115
- Brigham And Women's Hospital
-
-
Michigan
-
Royal Oak, Michigan, 미국, 48073
- Beaumont Health Systems
-
-
Minnesota
-
Minneapolis, Minnesota, 미국, 55414
- Minneapolis Heart Institute
-
-
New Jersey
-
Morristown, New Jersey, 미국, 07960
- Morristown Medical Center
-
-
New Mexico
-
Albuquerque, New Mexico, 미국, 87102
- New Mexico Heart Institute
-
-
New York
-
New York, New York, 미국, 10029
- Mount Sinai School of Medicine
-
New York, New York, 미국, 10075
- Lenox Hill Hospital
-
New York, New York, 미국, 10065
- New York Presbyterian - Weill Cornell Medical Ctr
-
Roslyn, New York, 미국, 11576
- St Francis Hospital
-
The Bronx, New York, 미국, 10467
- Montefiore Medical Center
-
-
North Carolina
-
Raleigh, North Carolina, 미국, 27610
- WakeMed Heart & Vascular
-
-
Ohio
-
Cleveland, Ohio, 미국, 44195
- Cleveland Clinic
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, 미국, 19104
- University of Pennsylvania Health System
-
York, Pennsylvania, 미국, 17403
- York Hospital
-
-
Texas
-
Austin, Texas, 미국, 78705
- Texas Cardiac Arrhythmia Research Foundation
-
Houston, Texas, 미국, 77030
- Texas Heart Institute
-
-
Utah
-
Murray, Utah, 미국, 84107
- Intermountain Medical Center
-
-
Virginia
-
Falls Church, Virginia, 미국, 22042
- Inova Fairfax Medical Campus- Inova Heart and Vascular Institute
-
Norfolk, Virginia, 미국, 23507
- Sentara Norfolk General Hospital
-
Richmond, Virginia, 미국, 23298
- Virginia Commonwealth University
-
-
-
-
-
Adelaide, 호주, 5000
- Royal Adelaide Hospital
-
Parkville, 호주, 03052
- Royal Melbourne Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
-
Diagnosed with symptomatic paroxysmal AF with:
- At least two symptomatic AF episodes within last six months from enrollment
- At least one electrocardiographically documented AF episode within twelve months prior to enrollment
-
Failed at least one Class I or Class III antiarrhythmic drug
-
Willing and capable to provide consent
-
Able and willing to comply with all pre-, post- and follow-up testing and requirements
Exclusion Criteria:
- Previously diagnosed with persistent AF (greater than [>] 7 days in duration)
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
- Previous surgical or catheter ablation for AF
- Patients known to require ablation outside the PV ostia and outside the CTI region.
- Documented severe dilatation of the left atrium (LAD>50 mm) antero-posterior diameter on imaging within 6 months prior to enrollment
- Documented left atrium (LA) thrombus by imaging within 48 hours of the procedure
- Documented severely compromised left ventricular ejection fraction (LVEF <40%) by imaging within 6 months prior to enrollment
- Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV
- History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
- Documented thromboembolic event (including transient ischemic attack or TIA) within the past 6 months
- Previous Percutaneous Coronary Intervention (PCI)/ myocardial infarction [MI] within the past 2 months
- Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months
- Valvular cardiac surgical/percutaneous procedure
- Unstable angina within 6 months
- Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months
- Significant pulmonary disease or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
- Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
- Prior diagnosis of pulmonary vein stenosis
- Pre-existing hemi diaphragmatic paralysis
- Acute illness, active systemic infection, or sepsis
- Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation
- Severe mitral regurgitation
- Presence of an implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device (other than coronary stents) that may interfere with the PF energy field)
- Presence of a condition that precludes vascular access
- Current enrollment in an investigational study evaluating another device or drug
- Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation
- Life expectancy less than 12 months
- Presenting contra-indications for the devices used in the study, as indicated in the respective Instructions for Use (IFU)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Pulsed Field (PF) Ablation System
Participants with PAF will undergo pulsed field ablation procedure with the OMNYPULSE™ catheter in combination with TRUPULSE™ generator for PVI and to deliver pulsed field (PF) energy for treatment of atrial fibrillation. Study participants will be followed for 12 months after the study index procedure. |
OMNYPULSE™ Catheter and TRUPULSE™ Generator will be used for PF ablation. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants with Primary Adverse Events (PAEs)
기간: 7 days post-procedure
|
Number of participants with PAEs (within 7 days following the ablation procedure unless otherwise indicated) will be reported. PAEs will include the following adverse events: esophageal perforating complications (atrio-esophageal fistula, esophago-pericardial fistula), phrenic nerve paralysis (permanent), cardiac tamponade/perforation, pulmonary vein stenosis (PVS), device or procedure related death, stroke/cerebrovascular accident (CVA), major vascular access complication/bleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency) and vagal nerve injury/gastroparesis. |
7 days post-procedure
|
|
Number of Participants Reporting Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT] or Atrial Flutter [AFL] of Unknown Origin) Episodes
기간: Day 91 to Day 365 post-procedure
|
Number of participants reporting freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (AF, AT, or AFL of unknown origin) episodes of >= 30 seconds based on sponsor provided transtelephonic monitoring (TTM) or holter device or continuous on standard 12-lead electrocardiogram (ECG) data during the effectiveness evaluation period will be reported. |
Day 91 to Day 365 post-procedure
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score
기간: Baseline, Month 12
|
The AFEQT uses a questionnaire to evaluate symptoms, daily activities and treatment concerns participants have related to atrial fibrillation. An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" difficult to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). A positive change in score corresponds to improvement in AF symptoms. |
Baseline, Month 12
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Biosense Webster, Inc. Clinical Trial, Biosense Webster, Inc.
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
이 연구와 관련된 용어
기타 연구 ID 번호
- BWI202303
- BWI202303 (기타 식별자: Biosense Webster, Inc.)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .