제세동 및 신뢰성에 대한 리드 평가(LEADR)
The LEADR study is designed to assess the safety and efficacy of the Next Generation ICD lead.
The LEADR LBBAP study is being conducted under the existing US FDA Investigational Device Exemption (IDE) for the Next Generation ICD Lead and is designed to confirm the safety and defibrillation efficacy of the Next Generation ICD Lead when placed in the LBBAP location in ICD and LOT-CRT patient population.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
The LEADR and LEADR LBBAP studies will enroll subjects who are indicated to receive an implantable single or dual chamber ICD, or CRT-D, and who meet all of the inclusion criteria and none of the exclusion criteria. Subjects will receive an investigational Next Generation ICD Lead. Subjects in the LEADR study will be followed for at least 18 months following Next Generation ICD Lead implantation in a septal (non-LBBAP) or apical implant location. Enrollment in the LEADR study has been completed (675 subjects enrolled). Subjects in the LEADR LBBAP study will be followed for at least 3 months (ICD-indicated subjects) or 6 months (CRT-indicated subjects) following Next Generation ICD Lead implantation in an LBBAP implant location. Enrollment in the LEADR LBBAP study has been completed (332 subjects enrolled).
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
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Limburg
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Maastricht, Limburg, 네덜란드
- LEADR LBBAP: Maastricht Universitair Medisch Centrum
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Copenhagen, 덴마크, 2100
- LEADR: Rigshospitalet
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Bielefeld
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Bielefeld, Bielefeld, 독일, 33604
- LEADR: Klinikum Bielefeld Kardiologie
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Kuala Lumpur, 말레이시아, 50400
- LEADR & LEADR LBBAP: Institut Jantung Negara - National Heart Institute
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Alabama
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Huntsville, Alabama, 미국, 35801
- LEADR: Heart Center Research
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California
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Torrance, California, 미국, 90505
- LEADR LBBAP: Torrance Memorial Medical Center
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Connecticut
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Hartford, Connecticut, 미국, 06106
- LEADR: Hartford Hospital
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Florida
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Tampa, Florida, 미국, 33606
- LEADR: University of South Florida
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Minnesota
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Minneapolis, Minnesota, 미국, 55407
- LEADR & LEADR LBBAP: Minneapolis Heart Institute Foundation
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Missouri
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Kansas City, Missouri, 미국, 64111
- LEADR: Saint Luke's Mid America Heart Institute
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St Louis, Missouri, 미국, 63110
- LEADR: Washington University School of Medicine
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New Jersey
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Voorhees Township, New Jersey, 미국, 08034
- LEADR: Lourdes Cardiology Services
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New Mexico
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Albuquerque, New Mexico, 미국, 87108
- LEADR: Presbyterian Heart Group
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New York
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Bay Shore, New York, 미국, 11030
- LEADR & LEADR LBBAP: South Shore University Hospital/Northwell Health
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Ohio
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Cincinnati, Ohio, 미국, 45202
- LEADR: TriHealth Hatton Research Institute
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Cincinnati, Ohio, 미국, 45219
- LEADR LBBAP: The Christ Hospital
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Cleveland, Ohio, 미국, 44195
- LEADR: Cleveland Clinic
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Columbus, Ohio, 미국, 43210
- LEADR LBBAP: The Ohio State University Wexner Medical Center
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Pennsylvania
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Allentown, Pennsylvania, 미국, 18103
- LEADR: Lehigh Valley Hospital - Cedar Crest
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Philadelphia, Pennsylvania, 미국, 19104
- LEADR: Hospital of the University of Pennsylvania
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Wilkes-Barre, Pennsylvania, 미국, 18711
- LEADR LBBAP: Geisinger Wyoming Valley Medical Center
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Tennessee
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Nashville, Tennessee, 미국, 37232
- LEADR& LEADR LBBAP: Vanderbilt University medical Center
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Texas
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Austin, Texas, 미국, 78705
- LEADR: Texas Cardiac Arrhythmia Research Foundation
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Fort Worth, Texas, 미국, 76104
- LEADR: Texas Health Fort Worth Hospital
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Virginia
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Charlottesville, Virginia, 미국, 22903
- LEADR & LEADR LBBAP: University of Virginia Medical Center
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Richmond, Virginia, 미국, 23298
- LEADR & LEADR LBBAP: Virginia Commonwealth University Health System
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Wisconsin
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Milwaukee, Wisconsin, 미국, 53215
- LEADR LBBAP: Aurora St. Luke's Hospital
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Antwerp
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Edegem, Antwerp, 벨기에, 2650
- LEADR LBBAP: Universitair Ziekenhuis Antwerpen
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Belgrade, 세르비아
- LEADR: Klinicki Centar Srbije Pejsmejker centar
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L'Hospitalet de Llobregat, 스페인
- LEADR: Hospital Universitari Bellvitge
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Valencia, 스페인, 46026
- LEADR: Hospital Universitario y Politécnico La Fe
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Granada
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Granada, Granada, 스페인, 18014
- LEADR LBBAP: Hospital Universitario Virgen de las Nieves
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Singapore
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Singapore, Singapore, 싱가포르
- LEADR: Ng Teng Fong General Hospital
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London, 영국, W12 0HS
- LEADR & LEADR LBBAP: Imperial College Healthcare NHS Trust - Hammersmith Hospital
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Mitterweg
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Krems, Mitterweg, 오스트리아, 3500
- LEADR: Universitätsklinikum Krems
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Bergamo, 이탈리아, 24127
- LEADR: Azienda Socio Sanitaria Territoriale (ASST) Papa Giovanni XXIII
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Fukuoka
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Kitakyushu, Fukuoka, 일본, 802-8555
- LEADR & LEADR LBBAP: Kokura Memorial Hospital
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Osaka
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Suita, Osaka, 일본, 564-8565
- LEADR & LEADR LBBAP: National Cerebral and Cardiovascular Center
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Tokyo
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Shinjuku-Ku, Tokyo, 일본, 162-8666
- LEADR: Tokyo Women's Medical University Hospital
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Chengdu, 중국
- LEADR & LEADR LBBAP: West China Hospital of Sichuan University
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Shanxi
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Taiyuan, Shanxi, 중국, 030000
- LEADR: Shanxi Cardiovascular Hospital
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Alberta
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Calgary, Alberta, 캐나다, T2N 4N1
- LEADR: University of Calgary
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Ontario
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Newmarket, Ontario, 캐나다, L3Y8C3
- LEADR: Southlake Regional Health Centre
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Quebec
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Québec, Quebec, 캐나다, G1V 4G5
- LEADR & LEADR LBBAP: Institut Universitaire de Cardiologie et de Pneumologie de Quebec
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Carnaxide, 포르투갈, 2790-134
- LEADR: Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz Cardiology
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Krakow, 폴란드
- LEADR LBBAP: Szpital Uniwersytecki w Krakowie
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La Tronche, 프랑스, 38700
- LEADR: Centre Hospitalier Universitaire de Grenoble - Site Nord
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Montpellier, 프랑스, 34960
- LEADR LBBAP: OC Santé - Clinique du Millénaire
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Rouen, 프랑스, 76031
- LEADR: CHU Hôpitaux de Rouen - Hôpital Charles Nicolle
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Garran, 호주, 2605
- LEADR &LEADR LBBAP: Canberra Hospital
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Queensland
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Chermside, Queensland, 호주, 4032
- LEADR & LEADR LBBAP: The Prince Charles Hospital
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South Australia
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Ashford, South Australia, 호주, 8032
- LEADR: Ashford Hospital
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Norwood, South Australia, 호주, 5000
- LEADR & LEADR LBBAP: Royal Adelaide
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Hong Kong, 홍콩
- LEADR & LEADR LBBAP: Queen Mary Hospital
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Lai Chi Kok, 홍콩, 999077
- LEADR: Princess Margaret Hospital
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
LEADR Inclusion Criteria:
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Subject meets current clinical practice guidelines for implantation of ICD or CRT-D and will undergo one of the following:
- de novo Medtronic CRT-D system implant
- de novo Medtronic ICD system implant (single or dual chamber)
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Subject has, per local law and requirements, the minimum age for autonomously signing an ICF (minimum age of 18 years)
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Subject is willing to undergo implant defibrillation testing if requested.
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Subject is geographically stable and willing and able to complete the study procedures and visits for the duration of the follow-up.
LEADR Exclusion Criteria:
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Subject is unwilling or unable to personally provide Informed Consent.
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Subject has contraindications for standard RV transvenous lead placement (e.g., mechanical right heart valve).
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Subject is contraindicated for ≤1 mg dexamethasone acetate.
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Subject has a life expectancy of less than 12 months
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For subject undergoing defibrillation testing the following medical conditions exclude them:
- Pre-existing or suspected pneumothorax during implant
- Current intracardiac left atrial or left ventricular (LV) thrombus
- Severe aortic stenosis
- Severe proximal three-vessel or left main coronary artery disease without revascularization
- Unstable angina
- Ejection Fraction less than 25%
- Recent stroke or transient ischemic attack (within the last 6 months)
- Known inadequate external defibrillation
- Any other known medical condition not listed that precludes their participation in the opinion of the investigator
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Subject is enrolled or planning to enroll in a concurrent clinical study that may confound the results of this study, without documented pre-approval from a Medtronic study manager.
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Subject with any exclusion criteria as required by local law (e.g., age or other).
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Pregnant women or breastfeeding women, or women of childbearing potential and who are not on a reliable form of birth regulation method or abstinence
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Subject with an existing pacemaker (including transcatheter pacing system), ICD, or CRT device or leads
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Subject with any evidence of active infection or undergoing treatment for an infection
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Recent (or planned) cardiac surgery or stenting less than 1 month before implant
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End stage renal disease
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Subjects with NYHA IV classification
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Subjects with a transplanted heart
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Subjects with previously extracted leads
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Subjects with Left Ventricular Assist Device
LEADR LBBAP Inclusion Criteria:
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Subject meets current local clinical practice guidelines for implantation of ICD (single or dual chamber) or CRT-D system and will undergo one of the following:
a) De novo Medtronic ICD system implant (single or dual chamber) or b) De novo Medtronic CRT-D system implant and is intended to also undergo LV lead implant (for patients indicated for CRT-D according to locally approved indications/indications)
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Subject is 12 years of age or older and also is greater than 30 kg in weight at time of enrollment, has cardiac anatomy conducive to RV coil placement, and is allowed to participate in study per local law and requirements. Subjects from 12 years of age until adult also have a separate indication for pacing or CRT or are anticipated to develop one.
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Subject provides written authorization and/or consent per institution and geographical requirements.
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Subject is geographically stable and willing and able to complete the study procedures and visits for the duration of the follow-up
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Subject is willing to undergo implant defibrillation testing if requested
LEADR LBBAP Exclusion Criteria:
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Subject has contraindication for screw-in active fixation transvenous lead placement (e.g., mechanical right heart valve)
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Subject is contraindicated for ≤1 mg dexamethasone acetate
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Subject has a life expectancy of less than 12 months
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For subject undergoing defibrillation testing the following medical conditions exclude them:
- Pre-existing or suspected pneumothorax
- Current intracardiac left atrial or LV thrombus
- Severe aortic stenosis
- Severe proximal three-vessel or left main coronary artery disease without revascularization
- Unstable angina
- Recent stroke or transient ischemic attack (within the last 6 months)
- Known inadequate external defibrillation
- Any other known medical condition not listed that precludes their participation in the opinion of the investigator
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Subject is enrolled or planning to enroll in a concurrent clinical study that may confound the results of this study, without documented pre-approval from a Medtronic study manager
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Subject is pregnant or breastfeeding, or subject is of childbearing potential and not on a reliable form of birth regulation method or abstinence
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Subject with an existing pacemaker (including transvenous and transcatheter pacing system), ICD (transvenous) or CRT-D (transvenous) device or leads
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Subject with previous subcutaneous ICD (S-ICD), extravascular ICD (EV ICD) or Implantable Cardiac Monitor explanted within 30 days before implant
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Subject with any evidence of active bacterial infection or undergoing treatment for a bacterial infection within the last 30 days
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Recent (or planned) cardiovascular intervention within 30 days before or after implant, such as cardiac surgery, cardiac ablation, Percutaneous Coronary Intervention (PCI), or temporary cardiac pacing for >12 hours
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Subjects with end stage renal disease
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Subjects with NYHA IV classification
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Subjects with a transplanted heart or on the waiting list for a heart transplant
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Subjects with previously extracted leads
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Subjects with Left Ventricular Assist Device
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Subjects that are vulnerable adults
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Intervention/Treatment (LEADR)
Patients will be implanted with a Next Generation ICD Lead and undergo required electrical testing |
Required electrical testing for pacing, sensing, impedance and defibrillation will be completed |
|
실험적: Intervention/Treatment (LEADR LBBAP)
Patients will be implanted with a Next Generation ICD Lead in the LBBAP location and undergo required electrical testing |
Required electrical testing for pacing, sensing, impedance and defibrillation will be completed |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
LEADR: Estimate the Rate of Major Lead Complication-free Rate at 6 Months
기간: Implant to 6 Months
|
Subjects free of Next Generation ICD lead-related complication at 6 months post-implant. |
Implant to 6 Months
|
|
LEADR: Percentage of Subjects Successfully Defibrillated at Implant With the Next Generation ICD Lead
기간: Day 1
|
Defibrillation testing will be completed in a subset of subjects at implant. |
Day 1
|
|
LEADR LBBAP: Percentage of Subjects Successfully Defibrillated at Implant With the Next Generation ICD Lead
기간: Day 1
|
Defibrillation testing will be completed with the Next Generation ICD Lead in the LBBAP location in a subset of subjects at implant. |
Day 1
|
|
LEADR LBBAP: The Lead-related Major Complication Rate at 3-months
기간: Implant to 3 Months
|
Subjects free of Next Generation ICD lead-related complication at 3 months post-implant. |
Implant to 3 Months
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
LEADR: Estimate the Fracture-free Rate of the Next Generation ICD Lead
기간: up to 18 months
|
Subjects will be assessed at certain time points for Next Generation ICD lead fracture related to the Next Generation ICD lead. |
up to 18 months
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: George Crossley, MD, Vanderbilt University (LEADR)
- 수석 연구원: Pugazhendhi Vijayaraman, MD, Geisinger Medical Center (LEADR LBBAP)
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- MDT19004 / MDT22048
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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. .