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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04863664




Registration number
NCT04863664
Ethics application status
Date submitted
21/04/2021
Date registered
28/04/2021
Date last updated
23/05/2024

Titles & IDs
Public title
Lead EvaluAtion for Defibrillation and Reliability (LEADR) / Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP)
Scientific title
Lead EvaluAtion for Defibrillation and Reliability (LEADR) / Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP)
Secondary ID [1] 0 0
MDT19004 / MDT22048
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tachyarrhythmia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Defibrillation (RV Implant)
Treatment: Devices - Defibrillation (LBBAP Implant)

Experimental: Intervention/Treatment (LEADR) - Patients will be implanted with a Next Generation ICD Lead and undergo required electrical testing

Experimental: Intervention/Treatment (LEADR LBBAP) - Patients will be implanted with a Next Generation ICD Lead in the LBBAP location and undergo required electrical testing


Treatment: Devices: Defibrillation (RV Implant)
Required electrical testing for pacing, sensing, impedance and defibrillation will be completed

Treatment: Devices: Defibrillation (LBBAP Implant)
Required electrical testing for pacing, sensing, impedance and defibrillation will be completed
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
LEADR: Estimate the rate of major Lead complication-free rate at 6 months
Timepoint [1] 0 0
Implant to 6 Months
Primary outcome [2] 0 0
LEADR: Percentage of subjects successfully defibrillated at implant with the Next Generation ICD lead
Timepoint [2] 0 0
Day 1
Primary outcome [3] 0 0
LEADR LBBAP: Percentage of subjects successfully defibrillated at implant with the Next Generation ICD lead
Timepoint [3] 0 0
Day 1
Primary outcome [4] 0 0
LEADR LBBAP: The lead-related major complication rate at 3-months
Timepoint [4] 0 0
Implant to 3 Months
Secondary outcome [1] 0 0
LEADR: Estimate the fracture-free rate of the Next Generation ICD lead
Timepoint [1] 0 0
up to 24 months

Eligibility
Key inclusion criteria
LEADR

- 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
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/11/2027
Actual
Sample size
Target
975
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA
Recruitment hospital [1] 0 0
LEADR & LEADR LBBAP: The Prince Charles Hospital - Chermside
Recruitment hospital [2] 0 0
LEADR: Ashford Hospital - Ashford
Recruitment hospital [3] 0 0
LEADR: Royal Adelaide - Norwood
Recruitment hospital [4] 0 0
LEADR: Canberra Hospital - Garran
Recruitment postcode(s) [1] 0 0
4032 - Chermside
Recruitment postcode(s) [2] 0 0
8032 - Ashford
Recruitment postcode(s) [3] 0 0
5000 - Norwood
Recruitment postcode(s) [4] 0 0
2605 - Garran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
New Mexico
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
Austria
State/province [14] 0 0
Mitterweg
Country [15] 0 0
Canada
State/province [15] 0 0
Alberta
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
China
State/province [18] 0 0
Shanxi
Country [19] 0 0
China
State/province [19] 0 0
Chengdu
Country [20] 0 0
Denmark
State/province [20] 0 0
Copenhagen
Country [21] 0 0
France
State/province [21] 0 0
La Tronche
Country [22] 0 0
France
State/province [22] 0 0
Rouen
Country [23] 0 0
Germany
State/province [23] 0 0
Bielefeld
Country [24] 0 0
Hong Kong
State/province [24] 0 0
Hong Kong
Country [25] 0 0
Hong Kong
State/province [25] 0 0
Lai Chi Kok
Country [26] 0 0
Italy
State/province [26] 0 0
Bergamo
Country [27] 0 0
Japan
State/province [27] 0 0
Fukuoka
Country [28] 0 0
Japan
State/province [28] 0 0
Osaka
Country [29] 0 0
Japan
State/province [29] 0 0
Tokyo
Country [30] 0 0
Malaysia
State/province [30] 0 0
Kuala Lumpur
Country [31] 0 0
Portugal
State/province [31] 0 0
Carnaxide
Country [32] 0 0
Serbia
State/province [32] 0 0
Belgrad
Country [33] 0 0
Singapore
State/province [33] 0 0
Singapore
Country [34] 0 0
Spain
State/province [34] 0 0
L'Hospitalet De Llobregat
Country [35] 0 0
Spain
State/province [35] 0 0
Valencia
Country [36] 0 0
United Kingdom
State/province [36] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medtronic Cardiac Rhythm and Heart Failure
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04863664
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
George Crossley, MD
Address 0 0
Vanderbilt University (LEADR)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Samantha Ly
Address 0 0
Country 0 0
Phone 0 0
857-324-3390
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04863664