Vedoucí hodnocení pro defibrilaci a spolehlivost (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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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).
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
-
Garran, Austrálie, 2605
- LEADR &LEADR LBBAP: Canberra Hospital
-
-
Queensland
-
Chermside, Queensland, Austrálie, 4032
- LEADR & LEADR LBBAP: The Prince Charles Hospital
-
-
South Australia
-
Ashford, South Australia, Austrálie, 8032
- LEADR: Ashford Hospital
-
Norwood, South Australia, Austrálie, 5000
- LEADR & LEADR LBBAP: Royal Adelaide
-
-
-
-
Antwerp
-
Edegem, Antwerp, Belgie, 2650
- LEADR LBBAP: Universitair Ziekenhuis Antwerpen
-
-
-
-
-
Copenhagen, Dánsko, 2100
- LEADR: Rigshospitalet
-
-
-
-
-
La Tronche, Francie, 38700
- LEADR: Centre Hospitalier Universitaire de Grenoble - Site Nord
-
Montpellier, Francie, 34960
- LEADR LBBAP: OC Santé - Clinique du Millénaire
-
Rouen, Francie, 76031
- LEADR: CHU Hôpitaux de Rouen - Hôpital Charles Nicolle
-
-
-
-
Limburg
-
Maastricht, Limburg, Holandsko
- LEADR LBBAP: Maastricht Universitair Medisch Centrum
-
-
-
-
-
Hong Kong, Hongkong
- LEADR & LEADR LBBAP: Queen Mary Hospital
-
Lai Chi Kok, Hongkong, 999077
- LEADR: Princess Margaret Hospital
-
-
-
-
-
Bergamo, Itálie, 24127
- LEADR: Azienda Socio Sanitaria Territoriale (ASST) Papa Giovanni XXIII
-
-
-
-
Fukuoka
-
Kitakyushu, Fukuoka, Japonsko, 802-8555
- LEADR & LEADR LBBAP: Kokura Memorial Hospital
-
-
Osaka
-
Suita, Osaka, Japonsko, 564-8565
- LEADR & LEADR LBBAP: National Cerebral and Cardiovascular Center
-
-
Tokyo
-
Shinjuku-Ku, Tokyo, Japonsko, 162-8666
- LEADR: Tokyo Women's Medical University Hospital
-
-
-
-
Alberta
-
Calgary, Alberta, Kanada, T2N 4N1
- LEADR: University of Calgary
-
-
Ontario
-
Newmarket, Ontario, Kanada, L3Y8C3
- LEADR: Southlake Regional Health Centre
-
-
Quebec
-
Québec, Quebec, Kanada, G1V 4G5
- LEADR & LEADR LBBAP: Institut Universitaire de Cardiologie et de Pneumologie de Quebec
-
-
-
-
-
Kuala Lumpur, Malajsie, 50400
- LEADR & LEADR LBBAP: Institut Jantung Negara - National Heart Institute
-
-
-
-
Bielefeld
-
Bielefeld, Bielefeld, Německo, 33604
- LEADR: Klinikum Bielefeld Kardiologie
-
-
-
-
-
Krakow, Polsko
- LEADR LBBAP: Szpital Uniwersytecki w Krakowie
-
-
-
-
-
Carnaxide, Portugalsko, 2790-134
- LEADR: Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz Cardiology
-
-
-
-
Mitterweg
-
Krems, Mitterweg, Rakousko, 3500
- LEADR: Universitätsklinikum Krems
-
-
-
-
Singapore
-
Singapore, Singapore, Singapur
- LEADR: Ng Teng Fong General Hospital
-
-
-
-
-
London, Spojené království, W12 0HS
- LEADR & LEADR LBBAP: Imperial College Healthcare NHS Trust - Hammersmith Hospital
-
-
-
-
Alabama
-
Huntsville, Alabama, Spojené státy, 35801
- LEADR: Heart Center Research
-
-
California
-
Torrance, California, Spojené státy, 90505
- LEADR LBBAP: Torrance Memorial Medical Center
-
-
Connecticut
-
Hartford, Connecticut, Spojené státy, 06106
- LEADR: Hartford Hospital
-
-
Florida
-
Tampa, Florida, Spojené státy, 33606
- LEADR: University of South Florida
-
-
Minnesota
-
Minneapolis, Minnesota, Spojené státy, 55407
- LEADR & LEADR LBBAP: Minneapolis Heart Institute Foundation
-
-
Missouri
-
Kansas City, Missouri, Spojené státy, 64111
- LEADR: Saint Luke's Mid America Heart Institute
-
St Louis, Missouri, Spojené státy, 63110
- LEADR: Washington University School of Medicine
-
-
New Jersey
-
Voorhees Township, New Jersey, Spojené státy, 08034
- LEADR: Lourdes Cardiology Services
-
-
New Mexico
-
Albuquerque, New Mexico, Spojené státy, 87108
- LEADR: Presbyterian Heart Group
-
-
New York
-
Bay Shore, New York, Spojené státy, 11030
- LEADR & LEADR LBBAP: South Shore University Hospital/Northwell Health
-
-
Ohio
-
Cincinnati, Ohio, Spojené státy, 45202
- LEADR: TriHealth Hatton Research Institute
-
Cincinnati, Ohio, Spojené státy, 45219
- LEADR LBBAP: The Christ Hospital
-
Cleveland, Ohio, Spojené státy, 44195
- LEADR: Cleveland Clinic
-
Columbus, Ohio, Spojené státy, 43210
- LEADR LBBAP: The Ohio State University Wexner Medical Center
-
-
Pennsylvania
-
Allentown, Pennsylvania, Spojené státy, 18103
- LEADR: Lehigh Valley Hospital - Cedar Crest
-
Philadelphia, Pennsylvania, Spojené státy, 19104
- LEADR: Hospital of the University of Pennsylvania
-
Wilkes-Barre, Pennsylvania, Spojené státy, 18711
- LEADR LBBAP: Geisinger Wyoming Valley Medical Center
-
-
Tennessee
-
Nashville, Tennessee, Spojené státy, 37232
- LEADR& LEADR LBBAP: Vanderbilt University medical Center
-
-
Texas
-
Austin, Texas, Spojené státy, 78705
- LEADR: Texas Cardiac Arrhythmia Research Foundation
-
Fort Worth, Texas, Spojené státy, 76104
- LEADR: Texas Health Fort Worth Hospital
-
-
Virginia
-
Charlottesville, Virginia, Spojené státy, 22903
- LEADR & LEADR LBBAP: University of Virginia Medical Center
-
Richmond, Virginia, Spojené státy, 23298
- LEADR & LEADR LBBAP: Virginia Commonwealth University Health System
-
-
Wisconsin
-
Milwaukee, Wisconsin, Spojené státy, 53215
- LEADR LBBAP: Aurora St. Luke's Hospital
-
-
-
-
-
Belgrade, Srbsko
- LEADR: Klinicki Centar Srbije Pejsmejker centar
-
-
-
-
-
Chengdu, Čína
- LEADR & LEADR LBBAP: West China Hospital of Sichuan University
-
-
Shanxi
-
Taiyuan, Shanxi, Čína, 030000
- LEADR: Shanxi Cardiovascular Hospital
-
-
-
-
-
L'Hospitalet de Llobregat, Španělsko
- LEADR: Hospital Universitari Bellvitge
-
Valencia, Španělsko, 46026
- LEADR: Hospital Universitario y Politécnico La Fe
-
-
Granada
-
Granada, Granada, Španělsko, 18014
- LEADR LBBAP: Hospital Universitario Virgen de las Nieves
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
LEADR Inclusion Criteria:
-
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)
-
Subject has, per local law and requirements, the minimum age for autonomously signing an ICF (minimum age of 18 years)
-
Subject is willing to undergo implant defibrillation testing if requested.
-
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:
-
Subject is unwilling or unable to personally provide Informed Consent.
-
Subject has contraindications for standard RV transvenous lead placement (e.g., mechanical right heart valve).
-
Subject is contraindicated for ≤1 mg dexamethasone acetate.
-
Subject has a life expectancy of less than 12 months
-
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
-
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.
-
Subject with any exclusion criteria as required by local law (e.g., age or other).
-
Pregnant women or breastfeeding women, or women of childbearing potential and who are not on a reliable form of birth regulation method or abstinence
-
Subject with an existing pacemaker (including transcatheter pacing system), ICD, or CRT device or leads
-
Subject with any evidence of active infection or undergoing treatment for an infection
-
Recent (or planned) cardiac surgery or stenting less than 1 month before implant
-
End stage renal disease
-
Subjects with NYHA IV classification
-
Subjects with a transplanted heart
-
Subjects with previously extracted leads
-
Subjects with Left Ventricular Assist Device
LEADR LBBAP Inclusion Criteria:
-
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)
-
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.
-
Subject provides written authorization and/or consent per institution and geographical requirements.
-
Subject is geographically stable and willing and able to complete the study procedures and visits for the duration of the follow-up
-
Subject is willing to undergo implant defibrillation testing if requested
LEADR LBBAP Exclusion Criteria:
-
Subject has contraindication for screw-in active fixation transvenous lead placement (e.g., mechanical right heart valve)
-
Subject is contraindicated for ≤1 mg dexamethasone acetate
-
Subject has a life expectancy of less than 12 months
-
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
-
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
-
Subject is pregnant or breastfeeding, or subject is of childbearing potential and not on a reliable form of birth regulation method or abstinence
-
Subject with an existing pacemaker (including transvenous and transcatheter pacing system), ICD (transvenous) or CRT-D (transvenous) device or leads
-
Subject with previous subcutaneous ICD (S-ICD), extravascular ICD (EV ICD) or Implantable Cardiac Monitor explanted within 30 days before implant
-
Subject with any evidence of active bacterial infection or undergoing treatment for a bacterial infection within the last 30 days
-
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
-
Subjects with end stage renal disease
-
Subjects with NYHA IV classification
-
Subjects with a transplanted heart or on the waiting list for a heart transplant
-
Subjects with previously extracted leads
-
Subjects with Left Ventricular Assist Device
-
Subjects that are vulnerable adults
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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 |
|
Experimentální: 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 |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
LEADR: Estimate the Rate of Major Lead Complication-free Rate at 6 Months
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Implant to 3 Months
|
Subjects free of Next Generation ICD lead-related complication at 3 months post-implant. |
Implant to 3 Months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
LEADR: Estimate the Fracture-free Rate of the Next Generation ICD Lead
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: George Crossley, MD, Vanderbilt University (LEADR)
- Vrchní vyšetřovatel: Pugazhendhi Vijayaraman, MD, Geisinger Medical Center (LEADR LBBAP)
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- MDT19004 / MDT22048
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .