Clinical trial NCT04863664: Lead EvaluAtion for Defibrillation and Reliability (LEADR) / Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP)
Official title: Lead EvaluAtion for Defibrillation and Reliability (LEADR) / Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tachyarrhythmia
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2021-04-28
Enrollment: 998
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 (323 subjects enrolled).

Eligibility criteria: 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

Primary outcomes:
measure: LEADR: Estimate the rate of major Lead complication-free rate at 6 months
timeFrame: Implant to 6 Months
measure: LEADR: Percentage of subjects successfully defibrillated at implant with the Next Generation ICD lead
timeFrame: Day 1
measure: LEADR LBBAP: Percentage of subjects successfully defibrillated at implant with the Next Generation ICD lead
timeFrame: Day 1
measure: LEADR LBBAP: The lead-related major complication rate at 3-months
timeFrame: Implant to 3 Months
Secondary outcomes:
measure: LEADR: Estimate the fracture-free rate of the Next Generation ICD lead
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: LEADR: Heart Center Research
state: Alabama
city: Torrance
country: United States
facility: LEADR LBBAP: Torrance Memorial Medical Center
state: California
city: Hartford
country: United States
facility: LEADR: Hartford Hospital
state: Connecticut
city: Tampa
country: United States
facility: LEADR: University of South Florida
state: Florida
city: Minneapolis
country: United States
facility: LEADR & LEADR LBBAP: Minneapolis Heart Institute Foundation
state: Minnesota
city: Kansas City
country: United States
facility: LEADR: Saint Luke's Mid America Heart Institute
state: Missouri
city: Saint Louis
country: United States
facility: LEADR: Washington University School of Medicine
state: Missouri
city: Voorhees
country: United States
facility: LEADR: Lourdes Cardiology Services
state: New Jersey
city: Albuquerque
country: United States
facility: LEADR: Presbyterian Heart Group
state: New Mexico
city: Bay Shore
country: United States
facility: LEADR & LEADR LBBAP: South Shore University Hospital/Northwell Health
state: New York
city: Cincinnati
country: United States
facility: LEADR: TriHealth Hatton Research Institute
state: Ohio
city: Cincinnati
country: United States
facility: LEADR LBBAP: The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: LEADR: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: LEADR LBBAP: The Ohio State University Wexner Medical Center
state: Ohio
city: Allentown
country: United States
facility: LEADR: Lehigh Valley Hospital - Cedar Crest
state: Pennsylvania
city: Philadelphia
country: United States
facility: LEADR: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Wilkes Barre
country: United States
facility: LEADR LBBAP: Geisinger Wyoming Valley Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: LEADR& LEADR LBBAP: Vanderbilt University medical Center
state: Tennessee
city: Austin
country: United States
facility: LEADR: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Fort Worth
country: United States
facility: LEADR: Texas Health Fort Worth Hospital
state: Texas
city: Charlottesville
country: United States
facility: LEADR & LEADR LBBAP: University of Virginia Medical Center
state: Virginia
city: Richmond
country: United States
facility: LEADR & LEADR LBBAP: Virginia Commonwealth University Health System
state: Virginia
city: Milwaukee
country: United States
facility: LEADR LBBAP: Aurora St. Luke's Hospital
state: Wisconsin
city: Chermside
country: Australia
facility: LEADR & LEADR LBBAP: The Prince Charles Hospital
state: Queensland
city: Ashford
country: Australia
facility: LEADR: Ashford Hospital
state: South Australia
city: Norwood
country: Australia
facility: LEADR & LEADR LBBAP: Royal Adelaide
state: South Australia
city: Garran
country: Australia
facility: LEADR &LEADR LBBAP: Canberra Hospital
city: Krems
country: Austria
facility: LEADR: Universitätsklinikum Krems
state: Mitterweg
city: Edegem
country: Belgium
facility: LEADR LBBAP: Universitair Ziekenhuis Antwerpen
state: Antwerp
city: Calgary
country: Canada
facility: LEADR: University of Calgary
state: Alberta
city: Newmarket
country: Canada
facility: LEADR: Southlake Regional Health Centre
state: Ontario
city: Québec City
country: Canada
facility: LEADR & LEADR LBBAP: Institut Universitaire de Cardiologie et de Pneumologie de Quebec
state: Quebec
city: Taiyuan
country: China
facility: LEADR: Shanxi Cardiovascular Hospital
state: Shanxi
city: Chengdu
country: China
facility: LEADR & LEADR LBBAP: West China Hospital of Sichuan University
city: Copenhagen
country: Denmark
facility: LEADR: Rigshospitalet
city: La Tronche
country: France
facility: LEADR: Centre Hospitalier Universitaire de Grenoble - Site Nord
city: Montpellier
country: France
facility: LEADR LBBAP: OC Santé - Clinique du Millénaire
city: Rouen
country: France
facility: LEADR: CHU Hôpitaux de Rouen - Hôpital Charles Nicolle
city: Bielefeld
country: Germany
facility: LEADR: Klinikum Bielefeld Kardiologie
city: Hong Kong
country: Hong Kong
facility: LEADR & LEADR LBBAP: Queen Mary Hospital
city: Lai Chi Kok
country: Hong Kong
facility: LEADR: Princess Margaret Hospital
city: Bergamo
country: Italy
facility: LEADR: Azienda Socio Sanitaria Territoriale (ASST) Papa Giovanni XXIII
city: Kitakyushu
country: Japan
facility: LEADR & LEADR LBBAP: Kokura Memorial Hospital
state: Fukuoka
city: Suita
country: Japan
facility: LEADR & LEADR LBBAP: National Cerebral and Cardiovascular Center
state: Osaka
city: Shinjuku-Ku
country: Japan
facility: LEADR: Tokyo Women's Medical University Hospital
state: Tokyo
city: Kuala Lumpur
country: Malaysia
facility: LEADR & LEADR LBBAP: Institut Jantung Negara - National Heart Institute
city: Maastricht
country: Netherlands
facility: LEADR LBBAP: Maastricht Universitair Medisch Centrum
state: Limburg
city: Kraków
country: Poland
facility: LEADR LBBAP: Szpital Uniwersytecki w Krakowie
city: Carnaxide
country: Portugal
facility: LEADR: Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz Cardiology
city: Belgrad
country: Serbia
facility: LEADR: Klinicki Centar Srbije Pejsmejker centar
city: Singapore
country: Singapore
facility: LEADR: Ng Teng Fong General Hospital
city: Granada
country: Spain
facility: LEADR LBBAP: Hospital Universitario Virgen de las Nieves
city: L'Hospitalet De Llobregat
country: Spain
facility: LEADR: Hospital Universitari Bellvitge
city: Valencia
country: Spain
facility: LEADR: Hospital Universitario y Politécnico La Fe
city: London
country: United Kingdom
facility: LEADR & LEADR LBBAP: Imperial College Healthcare NHS Trust - Hammersmith Hospital
Study officials:
affiliation: Vanderbilt University (LEADR)
name: George Crossley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Geisinger Medical Center (LEADR LBBAP)
name: Pugazhendhi Vijayaraman, MD
role: PRINCIPAL_INVESTIGATOR
References: