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ICD Lead
Defibrillator Lead for Rapid Heartbeat
N/A
Recruiting
Led By George Crossley, MD
Research Sponsored by Medtronic Cardiac Rhythm and Heart Failure
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject will undergo de novo Medtronic CRT-D system implant or de novo Medtronic ICD system implant (single or dual chamber)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
Study Summary
This trial will test a new type of heart defibrillator lead to see if it is safe and effective.
Who is the study for?
The LEADR trial is for individuals who need an ICD or CRT-D implant as per clinical guidelines, are willing to undergo defibrillation testing if needed, can attend follow-up visits, and can legally consent. Excluded are those with life expectancy under a year, certain heart conditions like severe aortic stenosis or ejection fraction <25%, existing pacemakers/ICDs/CRTs, recent cardiac procedures, end-stage renal disease, active infections or severe coronary artery disease without revascularization.Check my eligibility
What is being tested?
This study tests the safety and effectiveness of the Next Generation ICD lead in patients with tachyarrhythmias. Participants will receive either a new Medtronic CRT-D system implant or a new Medtronic ICD system (single/dual chamber) and may be asked to undergo defibrillation testing.See study design
What are the potential side effects?
While not explicitly listed in the provided information, typical side effects of defibrillation testing could include discomfort at the implant site, bruising or bleeding where the leads are placed, risk of infection at the incision site for device placement and potential complications from irregular heart rhythms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a new Medtronic CRT-D or ICD implant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
LEADR LBBAP: Percentage of subjects successfully defibrillated at implant with the Next Generation ICD lead
LEADR LBBAP: The lead-related major complication rate at 3-months
LEADR: Estimate the rate of major Lead complication-free rate at 6 months
+1 moreSecondary outcome measures
LEADR: Estimate the fracture-free rate of the Next Generation ICD lead
Trial Design
2Treatment groups
Experimental Treatment
Group I: Intervention/Treatment (LEADR)Experimental Treatment1 Intervention
Patients will be implanted with a Next Generation ICD Lead and undergo required electrical testing
Group II: Intervention/Treatment (LEADR LBBAP)Experimental Treatment1 Intervention
Patients will be implanted with a Next Generation ICD Lead in the LBBAP location and undergo required electrical testing
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Who is running the clinical trial?
Medtronic Cardiac Rhythm and Heart FailureLead Sponsor
198 Previous Clinical Trials
127,955 Total Patients Enrolled
1 Trials studying Tachyarrhythmias
2,770 Patients Enrolled for Tachyarrhythmias
George Crossley, MDPrincipal InvestigatorVanderbilt University (LEADR)
1 Previous Clinical Trials
175 Total Patients Enrolled
Pugazhendhi Vijayaraman, MDPrincipal InvestigatorGeisinger Medical Center (LEADR LBBAP)
3 Previous Clinical Trials
190 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can travel for study visits and follow all study procedures.I have had a stroke or a transient ischemic attack in the last 6 months.People who have had previous removal of medical leads.I am having a test for my heart's rhythm due to chest pain.I am willing to have a defibrillator test if needed.I had (or will have) heart surgery or stenting less than a month ago.I am legally old enough to consent to medical treatment.I am unable or unwilling to give my consent for participation.My kidneys are in the final stage of failure.I am scheduled for a new Medtronic CRT-D or ICD implant.I have had a heart transplant.I am not pregnant, breastfeeding, or able to become pregnant without birth control.I have severe narrowing of my heart's aortic valve and need a defibrillation test.I cannot take dexamethasone acetate at doses of 1 mg or less.You are currently undergoing a test for heart rhythm with a blood clot in your left atrium or left ventricle.I am having a defibrillator test and might have a collapsed lung.My heart pumps less blood than normal.You are not expected to live for more than 12 months.You have a pacemaker, ICD, or CRT device already implanted in your body.You have a medical condition that the doctor thinks makes it unsafe for you to participate in the defibrillation testing.I am currently fighting an infection or being treated for one.You are having a test to check if your defibrillator works properly and it has been found that it does not work well.I have severe heart artery disease without treatment, undergoing a specific heart test.You have a left ventricular assist device.I have severe heart failure symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention/Treatment (LEADR LBBAP)
- Group 2: Intervention/Treatment (LEADR)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
At how many different research institutions is this project being overseen?
"To make travelling as easy as possible for potential participants, the team conducting this clinical trial selected 22 locations which are situated in or near major cities such as Austin, Fort Worth and Tampa."
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