Lead EvaluAtion for Defibrillation and Reliability (LEADR) / Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP)

Tachyarrhythmia Clinical Trial

Official title:

Lead EvaluAtion for Defibrillation and Reliability (LEADR) / Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04863664
• Other study ID #: MDT19004 / MDT22048
• Status: Recruiting
• Phase: N/A
• Start date: June 21, 2021
• Est. completion date: November 30, 2027

Study information

• Verified date: April 2024
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: Samantha Ly
• Phone: 857-324-3390
• Email: samantha.ly[@]medtronic.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 975
• Est. completion date: November 30, 2027
• Est. primary completion date: August 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tachyarrhythmia
• Tachycardia

Intervention

Device:
• Defibrillation (RV Implant)
Required electrical testing for pacing, sensing, impedance and defibrillation will be completed
• Defibrillation (LBBAP Implant)
Required electrical testing for pacing, sensing, impedance and defibrillation will be completed

Locations

Country	Name	City	State
Australia	LEADR: Ashford Hospital	Ashford	South Australia
Australia	LEADR: The Prince Charles Hospital	Chermside	Queensland
Australia	LEADR: Canberra Hospital	Garran
Australia	LEADR: Royal Adelaide	Norwood	South Australia
Austria	LEADR: Universitätsklinikum Krems	Krems	Mitterweg
Canada	LEADR: University of Calgary	Calgary	Alberta
Canada	LEADR: Southlake Regional Health Centre	Newmarket	Ontario
Canada	LEADR: Institut Universitaire de Cardiologie et de Pneumologie de Quebec	Québec City	Quebec
China	LEADR: West China Hospital of Sichuan University	Chengdu
China	LEADR: Shanxi Cardiovascular Hospital	Taiyuan	Shanxi
Denmark	LEADR: Rigshospitalet	Copenhagen
France	LEADR: Centre Hospitalier Universitaire de Grenoble - Site Nord	La Tronche
France	LEADR: CHU Hôpitaux de Rouen - Hôpital Charles Nicolle	Rouen
Germany	LEADR: Klinikum Bielefeld Kardiologie	Bielefeld
Hong Kong	LEADR: Queen Mary Hospital	Hong Kong
Hong Kong	LEADR: Princess Margaret Hospital	Lai Chi Kok
Italy	LEADR: Azienda Socio Sanitaria Territoriale (ASST) Papa Giovanni XXIII	Bergamo
Japan	LEADR: Kokura Memorial Hospital	Kitakyushu	Fukuoka
Japan	LEADR: Tokyo Women's Medical University Hospital	Shinjuku-Ku	Tokyo
Japan	LEADR: National Cerebral and Cardiovascular Center	Suita	Osaka
Malaysia	LEADR: Institut Jantung Negara - National Heart Institute	Kuala Lumpur
Portugal	LEADR: Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz Cardiology	Carnaxide
Serbia	LEADR: Klinicki Centar Srbije Pejsmejker centar	Belgrad
Singapore	LEADR: Ng Teng Fong General Hospital	Singapore
Spain	LEADR: Hospital Universitari Bellvitge	L'Hospitalet De Llobregat
Spain	LEADR: Hospital Universitario y Politécnico La Fe	Valencia
United Kingdom	LEADR: Imperial College Healthcare NHS Trust - Hammersmith Hospital	London
United States	LEADR: Presbyterian Heart Group	Albuquerque	New Mexico
United States	LEADR: Lehigh Valley Hospital - Cedar Crest	Allentown	Pennsylvania
United States	LEADR: Texas Cardiac Arrhythmia Research Foundation	Austin	Texas
United States	LEADR: South Shore University Hospital	Bay Shore	New York
United States	LEADR: University of Virginia Medical Center	Charlottesville	Virginia
United States	LEADR: TriHealth Hatton Research Institute	Cincinnati	Ohio
United States	LEADR: Cleveland Clinic	Cleveland	Ohio
United States	LEADR LBBAP: The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	LEADR: Texas Health Fort Worth Hospital	Fort Worth	Texas
United States	LEADR: Hartford Hospital	Hartford	Connecticut
United States	LEADR: Heart Center Research	Huntsville	Alabama
United States	LEADR: Saint Luke's Mid America Heart Institute	Kansas City	Missouri
United States	LEADR & LEADR LBBAP: Minneapolis Heart Institute Foundation	Minneapolis	Minnesota
United States	LEADR: Vanderbilt University medical Center	Nashville	Tennessee
United States	LEADR: Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	LEADR: The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	LEADR: Virginia Commonwealth University Health System	Richmond	Virginia
United States	LEADR: Washington University School of Medicine	Saint Louis	Missouri
United States	LEADR: University of South Florida	Tampa	Florida
United States	LEADR: Lourdes Cardiology Services	Voorhees	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  China,  Denmark,  France,  Germany,  Hong Kong,  Italy,  Japan,  Malaysia,  Portugal,  Serbia,  Singapore,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LEADR: Estimate the rate of major Lead complication-free rate at 6 months	Subjects free of Next Generation ICD lead-related complication at 6 months post-implant.	Implant to 6 Months
Primary	LEADR: Percentage of subjects successfully defibrillated at implant with the Next Generation ICD lead	Defibrillation testing will be completed in a subset of subjects at implant.	Day 1
Primary	LEADR LBBAP: Percentage of subjects successfully defibrillated at implant with the Next Generation ICD lead	Defibrillation testing will be completed with the Next Generation ICD Lead in the LBBAP location in a subset of subjects at implant.	Day 1
Primary	LEADR LBBAP: The lead-related major complication rate at 3-months	Subjects free of Next Generation ICD lead-related complication at 3 months post-implant.	Implant to 3 Months
Secondary	LEADR: Estimate the fracture-free rate of the Next Generation ICD lead	Subjects will be assessed at certain time points for Next Generation ICD lead fracture related to the Next Generation ICD lead.	up to 24 months