Leadevaluatie voor defibrillatie en betrouwbaarheid (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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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).
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Garran, Australië, 2605
- LEADR &LEADR LBBAP: Canberra Hospital
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Queensland
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Chermside, Queensland, Australië, 4032
- LEADR & LEADR LBBAP: The Prince Charles Hospital
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South Australia
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Ashford, South Australia, Australië, 8032
- LEADR: Ashford Hospital
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Norwood, South Australia, Australië, 5000
- LEADR & LEADR LBBAP: Royal Adelaide
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Antwerp
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Edegem, Antwerp, België, 2650
- LEADR LBBAP: Universitair Ziekenhuis Antwerpen
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Alberta
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Calgary, Alberta, Canada, T2N 4N1
- LEADR: University of Calgary
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Ontario
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Newmarket, Ontario, Canada, L3Y8C3
- LEADR: Southlake Regional Health Centre
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Quebec
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Québec, Quebec, Canada, G1V 4G5
- LEADR & LEADR LBBAP: Institut Universitaire de Cardiologie et de Pneumologie de Quebec
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Chengdu, China
- LEADR & LEADR LBBAP: West China Hospital of Sichuan University
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Shanxi
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Taiyuan, Shanxi, China, 030000
- LEADR: Shanxi Cardiovascular Hospital
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Copenhagen, Denemarken, 2100
- LEADR: Rigshospitalet
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Bielefeld
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Bielefeld, Bielefeld, Duitsland, 33604
- LEADR: Klinikum Bielefeld Kardiologie
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La Tronche, Frankrijk, 38700
- LEADR: Centre Hospitalier Universitaire de Grenoble - Site Nord
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Montpellier, Frankrijk, 34960
- LEADR LBBAP: OC Santé - Clinique du Millénaire
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Rouen, Frankrijk, 76031
- LEADR: CHU Hôpitaux de Rouen - Hôpital Charles Nicolle
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Hong Kong, Hongkong
- LEADR & LEADR LBBAP: Queen Mary Hospital
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Lai Chi Kok, Hongkong, 999077
- LEADR: Princess Margaret Hospital
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Bergamo, Italië, 24127
- LEADR: Azienda Socio Sanitaria Territoriale (ASST) Papa Giovanni XXIII
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Fukuoka
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Kitakyushu, Fukuoka, Japan, 802-8555
- LEADR & LEADR LBBAP: Kokura Memorial Hospital
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Osaka
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Suita, Osaka, Japan, 564-8565
- LEADR & LEADR LBBAP: National Cerebral and Cardiovascular Center
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Tokyo
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Shinjuku-Ku, Tokyo, Japan, 162-8666
- LEADR: Tokyo Women's Medical University Hospital
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Kuala Lumpur, Maleisië, 50400
- LEADR & LEADR LBBAP: Institut Jantung Negara - National Heart Institute
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Limburg
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Maastricht, Limburg, Nederland
- LEADR LBBAP: Maastricht Universitair Medisch Centrum
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Mitterweg
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Krems, Mitterweg, Oostenrijk, 3500
- LEADR: Universitätsklinikum Krems
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Krakow, Polen
- LEADR LBBAP: Szpital Uniwersytecki w Krakowie
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Carnaxide, Portugal, 2790-134
- LEADR: Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz Cardiology
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Belgrade, Servië
- LEADR: Klinicki Centar Srbije Pejsmejker centar
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Singapore
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Singapore, Singapore, Singapore
- LEADR: Ng Teng Fong General Hospital
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L'Hospitalet de Llobregat, Spanje
- LEADR: Hospital Universitari Bellvitge
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Valencia, Spanje, 46026
- LEADR: Hospital Universitario y Politécnico La Fe
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Granada
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Granada, Granada, Spanje, 18014
- LEADR LBBAP: Hospital Universitario Virgen de las Nieves
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London, Verenigd Koninkrijk, W12 0HS
- LEADR & LEADR LBBAP: Imperial College Healthcare NHS Trust - Hammersmith Hospital
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Alabama
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Huntsville, Alabama, Verenigde Staten, 35801
- LEADR: Heart Center Research
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California
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Torrance, California, Verenigde Staten, 90505
- LEADR LBBAP: Torrance Memorial Medical Center
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Connecticut
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Hartford, Connecticut, Verenigde Staten, 06106
- LEADR: Hartford Hospital
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Florida
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Tampa, Florida, Verenigde Staten, 33606
- LEADR: University of South Florida
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Minnesota
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Minneapolis, Minnesota, Verenigde Staten, 55407
- LEADR & LEADR LBBAP: Minneapolis Heart Institute Foundation
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Missouri
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Kansas City, Missouri, Verenigde Staten, 64111
- LEADR: Saint Luke's Mid America Heart Institute
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St Louis, Missouri, Verenigde Staten, 63110
- LEADR: Washington University School of Medicine
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New Jersey
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Voorhees Township, New Jersey, Verenigde Staten, 08034
- LEADR: Lourdes Cardiology Services
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New Mexico
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Albuquerque, New Mexico, Verenigde Staten, 87108
- LEADR: Presbyterian Heart Group
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New York
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Bay Shore, New York, Verenigde Staten, 11030
- LEADR & LEADR LBBAP: South Shore University Hospital/Northwell Health
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Ohio
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Cincinnati, Ohio, Verenigde Staten, 45202
- LEADR: TriHealth Hatton Research Institute
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Cincinnati, Ohio, Verenigde Staten, 45219
- LEADR LBBAP: The Christ Hospital
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Cleveland, Ohio, Verenigde Staten, 44195
- LEADR: Cleveland Clinic
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Columbus, Ohio, Verenigde Staten, 43210
- LEADR LBBAP: The Ohio State University Wexner Medical Center
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Pennsylvania
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Allentown, Pennsylvania, Verenigde Staten, 18103
- LEADR: Lehigh Valley Hospital - Cedar Crest
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Philadelphia, Pennsylvania, Verenigde Staten, 19104
- LEADR: Hospital of the University of Pennsylvania
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Wilkes-Barre, Pennsylvania, Verenigde Staten, 18711
- LEADR LBBAP: Geisinger Wyoming Valley Medical Center
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Tennessee
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Nashville, Tennessee, Verenigde Staten, 37232
- LEADR& LEADR LBBAP: Vanderbilt University medical Center
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Texas
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Austin, Texas, Verenigde Staten, 78705
- LEADR: Texas Cardiac Arrhythmia Research Foundation
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Fort Worth, Texas, Verenigde Staten, 76104
- LEADR: Texas Health Fort Worth Hospital
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Virginia
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Charlottesville, Virginia, Verenigde Staten, 22903
- LEADR & LEADR LBBAP: University of Virginia Medical Center
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Richmond, Virginia, Verenigde Staten, 23298
- LEADR & LEADR LBBAP: Virginia Commonwealth University Health System
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Wisconsin
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Milwaukee, Wisconsin, Verenigde Staten, 53215
- LEADR LBBAP: Aurora St. Luke's Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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 |
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Experimenteel: 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 |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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LEADR: Estimate the Rate of Major Lead Complication-free Rate at 6 Months
Tijdsspanne: Implant to 6 Months
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Subjects free of Next Generation ICD lead-related complication at 6 months post-implant. |
Implant to 6 Months
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LEADR: Percentage of Subjects Successfully Defibrillated at Implant With the Next Generation ICD Lead
Tijdsspanne: Day 1
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Defibrillation testing will be completed in a subset of subjects at implant. |
Day 1
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LEADR LBBAP: Percentage of Subjects Successfully Defibrillated at Implant With the Next Generation ICD Lead
Tijdsspanne: Day 1
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Defibrillation testing will be completed with the Next Generation ICD Lead in the LBBAP location in a subset of subjects at implant. |
Day 1
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LEADR LBBAP: The Lead-related Major Complication Rate at 3-months
Tijdsspanne: Implant to 3 Months
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Subjects free of Next Generation ICD lead-related complication at 3 months post-implant. |
Implant to 3 Months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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LEADR: Estimate the Fracture-free Rate of the Next Generation ICD Lead
Tijdsspanne: up to 18 months
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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
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: George Crossley, MD, Vanderbilt University (LEADR)
- Hoofdonderzoeker: Pugazhendhi Vijayaraman, MD, Geisinger Medical Center (LEADR LBBAP)
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- MDT19004 / MDT22048
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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