Leadevaluering for defibrillering og pålitelighet (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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Garran, Australia, 2605
- LEADR &LEADR LBBAP: Canberra Hospital
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Queensland
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Chermside, Queensland, Australia, 4032
- LEADR & LEADR LBBAP: The Prince Charles Hospital
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South Australia
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Ashford, South Australia, Australia, 8032
- LEADR: Ashford Hospital
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Norwood, South Australia, Australia, 5000
- LEADR & LEADR LBBAP: Royal Adelaide
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Antwerp
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Edegem, Antwerp, Belgia, 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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Copenhagen, Danmark, 2100
- LEADR: Rigshospitalet
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Alabama
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Huntsville, Alabama, Forente stater, 35801
- LEADR: Heart Center Research
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California
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Torrance, California, Forente stater, 90505
- LEADR LBBAP: Torrance Memorial Medical Center
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Connecticut
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Hartford, Connecticut, Forente stater, 06106
- LEADR: Hartford Hospital
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Florida
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Tampa, Florida, Forente stater, 33606
- LEADR: University of South Florida
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55407
- LEADR & LEADR LBBAP: Minneapolis Heart Institute Foundation
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Missouri
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Kansas City, Missouri, Forente stater, 64111
- LEADR: Saint Luke's Mid America Heart Institute
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St Louis, Missouri, Forente stater, 63110
- LEADR: Washington University School of Medicine
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New Jersey
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Voorhees Township, New Jersey, Forente stater, 08034
- LEADR: Lourdes Cardiology Services
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New Mexico
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Albuquerque, New Mexico, Forente stater, 87108
- LEADR: Presbyterian Heart Group
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New York
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Bay Shore, New York, Forente stater, 11030
- LEADR & LEADR LBBAP: South Shore University Hospital/Northwell Health
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Ohio
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Cincinnati, Ohio, Forente stater, 45202
- LEADR: TriHealth Hatton Research Institute
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Cincinnati, Ohio, Forente stater, 45219
- LEADR LBBAP: The Christ Hospital
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Cleveland, Ohio, Forente stater, 44195
- LEADR: Cleveland Clinic
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Columbus, Ohio, Forente stater, 43210
- LEADR LBBAP: The Ohio State University Wexner Medical Center
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Pennsylvania
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Allentown, Pennsylvania, Forente stater, 18103
- LEADR: Lehigh Valley Hospital - Cedar Crest
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Philadelphia, Pennsylvania, Forente stater, 19104
- LEADR: Hospital of the University of Pennsylvania
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Wilkes-Barre, Pennsylvania, Forente stater, 18711
- LEADR LBBAP: Geisinger Wyoming Valley Medical Center
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Tennessee
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Nashville, Tennessee, Forente stater, 37232
- LEADR& LEADR LBBAP: Vanderbilt University medical Center
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Texas
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Austin, Texas, Forente stater, 78705
- LEADR: Texas Cardiac Arrhythmia Research Foundation
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Fort Worth, Texas, Forente stater, 76104
- LEADR: Texas Health Fort Worth Hospital
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Virginia
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Charlottesville, Virginia, Forente stater, 22903
- LEADR & LEADR LBBAP: University of Virginia Medical Center
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Richmond, Virginia, Forente stater, 23298
- LEADR & LEADR LBBAP: Virginia Commonwealth University Health System
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Wisconsin
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Milwaukee, Wisconsin, Forente stater, 53215
- LEADR LBBAP: Aurora St. Luke's Hospital
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La Tronche, Frankrike, 38700
- LEADR: Centre Hospitalier Universitaire de Grenoble - Site Nord
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Montpellier, Frankrike, 34960
- LEADR LBBAP: OC Santé - Clinique du Millénaire
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Rouen, Frankrike, 76031
- LEADR: CHU Hôpitaux de Rouen - Hôpital Charles Nicolle
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Hong Kong, Hong Kong
- LEADR & LEADR LBBAP: Queen Mary Hospital
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Lai Chi Kok, Hong Kong, 999077
- LEADR: Princess Margaret Hospital
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Bergamo, Italia, 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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Chengdu, Kina
- LEADR & LEADR LBBAP: West China Hospital of Sichuan University
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Shanxi
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Taiyuan, Shanxi, Kina, 030000
- LEADR: Shanxi Cardiovascular Hospital
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Kuala Lumpur, Malaysia, 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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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, Serbia
- 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, Spania
- LEADR: Hospital Universitari Bellvitge
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Valencia, Spania, 46026
- LEADR: Hospital Universitario y Politécnico La Fe
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Granada
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Granada, Granada, Spania, 18014
- LEADR LBBAP: Hospital Universitario Virgen de las Nieves
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London, Storbritannia, W12 0HS
- LEADR & LEADR LBBAP: Imperial College Healthcare NHS Trust - Hammersmith Hospital
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Bielefeld
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Bielefeld, Bielefeld, Tyskland, 33604
- LEADR: Klinikum Bielefeld Kardiologie
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Mitterweg
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Krems, Mitterweg, Østerrike, 3500
- LEADR: Universitätsklinikum Krems
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 |
|
Eksperimentell: 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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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LEADR: Estimate the Rate of Major Lead Complication-free Rate at 6 Months
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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LEADR: Estimate the Fracture-free Rate of the Next Generation ICD Lead
Tidsramme: 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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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: George Crossley, MD, Vanderbilt University (LEADR)
- Hovedetterforsker: Pugazhendhi Vijayaraman, MD, Geisinger Medical Center (LEADR LBBAP)
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MDT19004 / MDT22048
Plan for individuelle deltakerdata (IPD)
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Legemiddel- og utstyrsinformasjon, studiedokumenter
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