ОЦЕНКА ОТВОДОВ ДЛЯ ДЕФИБРИЛЛЯЦИИ И НАДЕЖНОСТИ (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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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).
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Garran, Австралия, 2605
- LEADR &LEADR LBBAP: Canberra Hospital
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Queensland
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Chermside, Queensland, Австралия, 4032
- LEADR & LEADR LBBAP: The Prince Charles Hospital
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South Australia
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Ashford, South Australia, Австралия, 8032
- LEADR: Ashford Hospital
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Norwood, South Australia, Австралия, 5000
- LEADR & LEADR LBBAP: Royal Adelaide
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Mitterweg
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Krems, Mitterweg, Австрия, 3500
- LEADR: Universitätsklinikum Krems
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Antwerp
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Edegem, Antwerp, Бельгия, 2650
- LEADR LBBAP: Universitair Ziekenhuis Antwerpen
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Bielefeld
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Bielefeld, Bielefeld, Германия, 33604
- LEADR: Klinikum Bielefeld Kardiologie
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Hong Kong, Гонконг
- LEADR & LEADR LBBAP: Queen Mary Hospital
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Lai Chi Kok, Гонконг, 999077
- LEADR: Princess Margaret Hospital
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Copenhagen, Дания, 2100
- LEADR: Rigshospitalet
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L'Hospitalet de Llobregat, Испания
- LEADR: Hospital Universitari Bellvitge
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Valencia, Испания, 46026
- LEADR: Hospital Universitario y Politécnico La Fe
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Granada
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Granada, Granada, Испания, 18014
- LEADR LBBAP: Hospital Universitario Virgen de las Nieves
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Bergamo, Италия, 24127
- LEADR: Azienda Socio Sanitaria Territoriale (ASST) Papa Giovanni XXIII
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Alberta
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Calgary, Alberta, Канада, T2N 4N1
- LEADR: University of Calgary
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Ontario
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Newmarket, Ontario, Канада, L3Y8C3
- LEADR: Southlake Regional Health Centre
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Quebec
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Québec, Quebec, Канада, G1V 4G5
- LEADR & LEADR LBBAP: Institut Universitaire de Cardiologie et de Pneumologie de Quebec
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Chengdu, Китай
- LEADR & LEADR LBBAP: West China Hospital of Sichuan University
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Shanxi
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Taiyuan, Shanxi, Китай, 030000
- LEADR: Shanxi Cardiovascular Hospital
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Kuala Lumpur, Малайзия, 50400
- LEADR & LEADR LBBAP: Institut Jantung Negara - National Heart Institute
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Limburg
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Maastricht, Limburg, Нидерланды
- LEADR LBBAP: Maastricht Universitair Medisch Centrum
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Krakow, Польша
- LEADR LBBAP: Szpital Uniwersytecki w Krakowie
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Carnaxide, Португалия, 2790-134
- LEADR: Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz Cardiology
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Belgrade, Сербия
- LEADR: Klinicki Centar Srbije Pejsmejker centar
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Singapore
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Singapore, Singapore, Сингапур
- LEADR: Ng Teng Fong General Hospital
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London, Соединенное Королевство, W12 0HS
- LEADR & LEADR LBBAP: Imperial College Healthcare NHS Trust - Hammersmith Hospital
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Alabama
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Huntsville, Alabama, Соединенные Штаты, 35801
- LEADR: Heart Center Research
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California
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Torrance, California, Соединенные Штаты, 90505
- LEADR LBBAP: Torrance Memorial Medical Center
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Connecticut
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Hartford, Connecticut, Соединенные Штаты, 06106
- LEADR: Hartford Hospital
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Florida
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Tampa, Florida, Соединенные Штаты, 33606
- LEADR: University of South Florida
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Minnesota
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Minneapolis, Minnesota, Соединенные Штаты, 55407
- LEADR & LEADR LBBAP: Minneapolis Heart Institute Foundation
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Missouri
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Kansas City, Missouri, Соединенные Штаты, 64111
- LEADR: Saint Luke's Mid America Heart Institute
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St Louis, Missouri, Соединенные Штаты, 63110
- LEADR: Washington University School of Medicine
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New Jersey
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Voorhees Township, New Jersey, Соединенные Штаты, 08034
- LEADR: Lourdes Cardiology Services
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New Mexico
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Albuquerque, New Mexico, Соединенные Штаты, 87108
- LEADR: Presbyterian Heart Group
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New York
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Bay Shore, New York, Соединенные Штаты, 11030
- LEADR & LEADR LBBAP: South Shore University Hospital/Northwell Health
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Ohio
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Cincinnati, Ohio, Соединенные Штаты, 45202
- LEADR: TriHealth Hatton Research Institute
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Cincinnati, Ohio, Соединенные Штаты, 45219
- LEADR LBBAP: The Christ Hospital
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Cleveland, Ohio, Соединенные Штаты, 44195
- LEADR: Cleveland Clinic
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Columbus, Ohio, Соединенные Штаты, 43210
- LEADR LBBAP: The Ohio State University Wexner Medical Center
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Pennsylvania
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Allentown, Pennsylvania, Соединенные Штаты, 18103
- LEADR: Lehigh Valley Hospital - Cedar Crest
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Philadelphia, Pennsylvania, Соединенные Штаты, 19104
- LEADR: Hospital of the University of Pennsylvania
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Wilkes-Barre, Pennsylvania, Соединенные Штаты, 18711
- LEADR LBBAP: Geisinger Wyoming Valley Medical Center
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Tennessee
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Nashville, Tennessee, Соединенные Штаты, 37232
- LEADR& LEADR LBBAP: Vanderbilt University medical Center
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Texas
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Austin, Texas, Соединенные Штаты, 78705
- LEADR: Texas Cardiac Arrhythmia Research Foundation
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Fort Worth, Texas, Соединенные Штаты, 76104
- LEADR: Texas Health Fort Worth Hospital
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Virginia
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Charlottesville, Virginia, Соединенные Штаты, 22903
- LEADR & LEADR LBBAP: University of Virginia Medical Center
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Richmond, Virginia, Соединенные Штаты, 23298
- LEADR & LEADR LBBAP: Virginia Commonwealth University Health System
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Wisconsin
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Milwaukee, Wisconsin, Соединенные Штаты, 53215
- LEADR LBBAP: Aurora St. Luke's Hospital
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La Tronche, Франция, 38700
- LEADR: Centre Hospitalier Universitaire de Grenoble - Site Nord
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Montpellier, Франция, 34960
- LEADR LBBAP: OC Santé - Clinique du Millénaire
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Rouen, Франция, 76031
- LEADR: CHU Hôpitaux de Rouen - Hôpital Charles Nicolle
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Fukuoka
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Kitakyushu, Fukuoka, Япония, 802-8555
- LEADR & LEADR LBBAP: Kokura Memorial Hospital
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Osaka
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Suita, Osaka, Япония, 564-8565
- LEADR & LEADR LBBAP: National Cerebral and Cardiovascular Center
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Tokyo
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Shinjuku-Ku, Tokyo, Япония, 162-8666
- LEADR: Tokyo Women's Medical University Hospital
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Нерандомизированный
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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 |
|
Экспериментальный: 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 |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
LEADR: Estimate the Rate of Major Lead Complication-free Rate at 6 Months
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Implant to 3 Months
|
Subjects free of Next Generation ICD lead-related complication at 3 months post-implant. |
Implant to 3 Months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
LEADR: Estimate the Fracture-free Rate of the Next Generation ICD Lead
Временное ограничение: 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
|
Соавторы и исследователи
Следователи
- Главный следователь: George Crossley, MD, Vanderbilt University (LEADR)
- Главный следователь: Pugazhendhi Vijayaraman, MD, Geisinger Medical Center (LEADR LBBAP)
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- MDT19004 / MDT22048
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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