Defibrillator Lead for Rapid Heartbeat
Recruiting in Palo Alto (17 mi)
+122 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Must not be taking: Dexamethasone
Disqualifiers: Infection, Recent surgery, Heart transplant, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor to get a clear answer.
What data supports the effectiveness of the treatment Next Generation ICD lead?
The research indicates that newer ICD leads, like the Next Generation ICD lead, have been developed to improve long-term reliability and reduce complications associated with lead failure. These advancements in design and technology aim to enhance the safety and effectiveness of ICD therapy in preventing sudden cardiac arrest.
12345Is the Defibrillator Lead for Rapid Heartbeat generally safe for humans?
Some defibrillator leads, like the Medtronic Sprint Fidelis and St. Jude Medical Riata, have shown increased failure rates, leading to patient harm. It's important to monitor patients with these leads closely and ensure that any new lead designs are thoroughly tested for long-term safety.
12567How is the Next Generation ICD lead treatment different from other treatments for rapid heartbeat?
The Next Generation ICD lead is unique because it is a small-diameter, lumenless, catheter-delivered defibrillator lead designed to improve long-term reliability, addressing the common issue of lead failure in traditional ICD systems.
12589Eligibility Criteria
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.Inclusion Criteria
I can travel for study visits and follow all study procedures.
I am willing to have a defibrillator test if needed.
I am legally old enough to consent to medical treatment.
+2 more
Exclusion Criteria
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
I have had a stroke or a transient ischemic attack in the last 6 months.
People who have had previous removal of medical leads.
+21 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Implantation and Initial Testing
Participants receive the Next Generation ICD Lead and undergo required electrical testing
Day 1
1 visit (in-person)
Follow-up (LEADR LBBAP)
Participants are monitored for lead-related complications and defibrillation efficacy
3 months
Regular visits as per protocol
Follow-up (LEADR)
Participants are monitored for lead-related complications and fracture-free rate
18 months
Regular visits as per protocol
Extended Follow-up
Participants are monitored for long-term safety and lead performance
up to 24 months
Participant Groups
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.
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
Next Generation ICD lead is already approved in United States for the following indications:
🇺🇸 Approved in United States as Next Generation ICD lead for:
- Life-threatening ventricular arrhythmias
- Cardiac resynchronization therapy
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
LEADR & LEADR LBBAP: Minneapolis Heart Institute FoundationMinneapolis, MN
LEADR LBBAP: Torrance Memorial Medical CenterTorrance, CA
LEADR: Hartford HospitalHartford, CT
LEADR & LEADR LBBAP: South Shore University Hospital/Northwell HealthBay Shore, NY
More Trial Locations
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Who Is Running the Clinical Trial?
Medtronic Cardiac Rhythm and Heart FailureLead Sponsor
References
Rationale and design of the Lead Evaluation for Defibrillation and Reliability study: Safety and efficacy of a novel ICD lead design. [2023]Implantable cardioverter defibrillators (ICD) are indicated for primary and secondary prevention of sudden cardiac arrest. Despite enhancements in design and technologies, the ICD lead is the most vulnerable component of the ICD system and failure of ICD leads remains a significant clinical problem. A novel, small-diameter, lumenless, catheter-delivered, defibrillator lead was developed with the aim to improve long-term reliability.
Sprint Fidelis implantable cardioverter-defibrillators lead patient management and survival: Single center study. [2018]Over the last several years significant rises in the use of implanted cardioverter-defibrillators (ICD) have also resulted in a number of associated complications. This number includes lead failure. Sprint Fidelis (SF) ICD lead is regarded as a lead with elevated failure risk. Every center acting in accordance with the guidelines should observe patients more thoroughly especially with recalled leads and run a registry of their follow-up. The aim of this research was to present follow-up of the patients with SF leads (types 6948, 6949) from a single implantation center.
[Initial clinical results with a novel implantable cardioverter-defibrillator: a prospective evaluation in 3 Swiss university hospitals]. [2006]The most important technical improvements of implantable cardioverter-defibrillators (ICD) of the latest generation comprise more sophisticated antitachycardia pacing options, stored intracardiac electrograms and biphasic shock capabilities which virtually always allow ICD implantation without thoracotomy. The present study summarizes the first clinical experience with these new devices. In 37 consecutive symptomatic (near sudden death 17, syncope 16, pre-syncope 4) patients aged 56 +/- 10 years with refractory ventricular arrhythmias (presenting arrhythmia: ventricular fibrillation 14, ventricular tachycardia 22, not documented 1), an ICD (Jewel PCD 7219, Medtronic) was implanted. Coronary artery disease was present in 21, dilated cardiomyopathy in 5, valvular heart disease in 2 and various conditions in 8 patients; the mean left ventricular ejection fraction was 43 +/- 18%. In 29 patients (78%), the ICD was inserted in a pectoral and in 8 (22%) in an abdominal position. A non-thoracotomy lead (NTL) configuration was successfully implanted in 36/37 patients (97%) (purely transvenous systems in 30, in combination with subcutaneous patch electrode in 6). Surgical complications comprised one pneumothorax, one hemorrhage and one death due to sepsis; during a mean follow-up of 5 +/- 3 months, another patient died of heart failure and 2 revisions (5.4%) for lead problems (1 connector, 1 SQ-patch) became necessary. In 23/37 patients (62%), the ICD was activated after 74 +/- 89 days post implant. 22 of these 23 patients (96%) received one or more appropriate shocks (9 +/- 22 shocks per patient). The actuarial survival was 95% at 6 months. In the present study, an ICD of the newest generation was successfully implanted without thoracotomy in > or = 97% and with purely transvenous systems in > or = 84%. Compared to older systems, this has made the implantation procedure remarkably easier and will most likely lead to a further reduction in mortality and morbidity. Despite the relatively short follow-up, the high incidence of appropriate ICD utilization underscores the high recurrence rate of arrhythmias in this population and suggests that the ICD may be very effective in preventing unnecessary rehospitalizations.
Implantable cardioverter-defibrillator lead failure: how weak is the link? [2008]The implantable cardioverter-defibrillator (ICD) has been shown to decrease the risk of sudden cardiac death in patients when used for primary and secondary prevention. These devices are being used more frequently as indications for primary prevention broaden, and attention has become increasingly focused on complications caused by lead failure. A report using data from a large registry revealed that the cumulative incidence of lead malfunction that necessitated surgical revision of the ICD lead system was 2.5% over 5 years. A strategy to deal with failed leads by the implantation of new pace-sense leads or high-voltage leads resulted in a 20% malfunction recurrence rate at 5 years. Defibrillator leads have been termed the 'weakest link' in the ICD system. Further efforts from manufacturers, regulators, and implanting physicians are required to understand and address the causes of lead failure.
[ICD leads]. [2018]Implantable cardioverter-defibrillator (ICD) leads have to fulfill particular requirements: safe pacing and sensing, detection, and termination of ventricular tachyarrhythmias, if necessary by (multiple) high-energy shocks. At the same time, their implantation has to be simple, they need to provide excellent long-term stability and they must be completely and safely extractable. Numerous technical developments have enabled currently available ICD leads to fulfill these expectations to a high extent. However, some changes of lead design, materials, and manufacturing processes have led to increased lead failure, especially in two lead models (Medtronic Sprint Fidelis®, St. Jude Medical Riata®). The high rate of lead failure was identified only several years after market release, in part because there are no appropriate registries of ICD leads. This review presents background and developments of ICD lead technology and their association with the clinical usage of ICD therapy. To also benefit patients with only slightly-to-moderately increased risk of ventricular tachyarrhythmia, optimum ICD therapy requires optimal leads and sufficiently experienced implanters.
Performance of the St. Jude Medical Riata leads. [2022]Recent attention has been focused on the performance of high-voltage implantable cardioverter-defibrillator (ICD) leads. Lead-related adverse events can be caused by several factors, including patient characteristics, concomitant therapies, implantation technique, access site, and lead design. Few studies have included the number of patients and the follow-up duration necessary to characterize accurately the lead performance and the incidence of lead-related adverse events.
Active Surveillance of the Implantable Cardioverter-Defibrillator Registry for Defibrillator Lead Failures. [2021]Several defibrillator leads have been recalled due to early lead failure leading to significant patient harm. Confirming the safety of contemporary defibrillator leads is essential to optimizing treatment for patients receiving implantable cardioverter-defibrillators (ICDs). We therefore sought to assess the comparative long-term safety of the 4 most commonly implanted ICD leads within the National Cardiovascular Data Registry ICD Registry.
Optimal management of Riata leads with no known electrical abnormalities or externalization: a decision analysis. [2015]Riata and Riata ST implantable cardioverter-defibrillator (ICD) leads (St. Jude Medical, Sylmar, CA, USA) can develop conductor cable externalization and/or electrical failure. Optimal management of these leads remains unknown.
The efficacy of the LinoxSmart DX ICD lead from a single center experience. [2020]Label="PURPOSE" NlmCategory="OBJECTIVE">The Biotronik LinoxSmart DX implanted cardioverter defibrillator (ICD) lead is a novel VDD lead with the advantage of integrated atrial sensing dipole combined with a special augmentation and filtering mechanisms. We sought to determine the efficacy of the Biotronik LinoxSmart DX ICD lead.