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

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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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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), 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)

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.

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.

Subject has contraindication for screw-in active fixation transvenous lead placement (e.g., mechanical right heart valve).

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.

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Eligibility

Age eligible for study : 12 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2021-06-21

Primary completion: 2025-07-31

Study completion finish: 2027-11-30

Study type

TREATMENT

Phase

Trial ID

NCT04863664

Intervention or treatment

DEVICE: Defibrillation (RV Implant)

DEVICE: Defibrillation (LBBAP Implant)

Conditions

• Tachyarrhythmia

Condition: Tachyarrhythmia
DEVICE: Defibrillation (RV Implant) and other drugs
Chermside, Queensland, Australia and more
Sponsor: Medtronic Cardiac Rhythm and Heart Failure

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Find a site

Closest Location:

LEADR & LEADR LBBAP: The Prince Charles Hospital

Research sites nearby

Select from list below to view details:

LEADR & LEADR LBBAP: The Prince Charles Hospital
Chermside, Queensland, Australia
LEADR: Ashford Hospital
Ashford, South Australia, Australia
LEADR: Royal Adelaide
Norwood, South Australia, Australia
LEADR &LEADR LBBAP: Canberra Hospital
Garran, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Intervention/Treatment (LEADR) Patients will be implanted with a Next Generation ICD Lead and undergo required electrical testing	DEVICE: Defibrillation (RV Implant) Required electrical testing for pacing, sensing, impedance and defibrillation will be completed
EXPERIMENTAL: Intervention/Treatment (LEADR LBBAP) Patients will be implanted with a Next Generation ICD Lead in the LBBAP location and undergo required electrical testing	DEVICE: Defibrillation (LBBAP Implant) Required electrical testing for pacing, sensing, impedance and defibrillation will be completed

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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
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
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
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 outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
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

Frequently Asked Questions

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References

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