Defibrillator Lead for Rapid Heartbeat

No longer recruiting at 129 trial locations

Overseen By Katrien Vandersteegen

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Must not be taking: Dexamethasone

Disqualifiers: Infection, Recent surgery, Heart transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new defibrillator lead, the Next Generation ICD lead, to determine its safety and effectiveness for individuals with specific heart conditions. It evaluates the lead's performance when placed in the heart, particularly for those requiring an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy (CRT). Suitable candidates include those needing or receiving a new Medtronic ICD or CRT-D system and willing to undergo testing during the procedure. As an unphased trial, this study allows patients to contribute to the development of innovative heart treatments.

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 prior data suggests that this device is safe for patients with rapid heartbeat?

Research has shown that ICDs (implantable cardioverter-defibrillators), which include wires called leads, are generally safe, with a yearly lead failure rate of about 0.5%. This means that out of 200 devices, about one might experience an issue each year.

However, some problems can occur. One study found 23 cases where the lead or device moved, potentially requiring adjustments or repairs. Another report mentioned three deaths, attributed to other health issues, not the device itself.

The Next Generation ICD lead undergoes thorough testing to ensure safety. While some risks exist, efforts focus on reducing them and improving device performance. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Next Generation ICD Lead because it offers potential improvements in treating rapid heartbeats. Unlike traditional ICD leads, this new lead is designed to be implanted in the left bundle branch area (LBBAP), which may enhance electrical conduction efficiency and reduce complications. This method aims to improve patient outcomes by offering a more targeted approach to heart rhythm management, potentially leading to better synchronization of heartbeats and fewer side effects.

What evidence suggests that the Next Generation ICD lead is effective for rapid heartbeat?

Research shows that the Next Generation ICD lead effectively delivers electrical shocks to prevent dangerous heart rhythms. Studies have found that this lead successfully stops rapid heartbeats in over 88% of patients. In this trial, some participants will have the lead placed in the LBBAP location, where early results appear promising. Successful placement with good heart monitoring and pacing was achieved in 75% of patients, leading to improved heart rhythms. Overall, these studies suggest that the new ICD lead design effectively manages and treats rapid heartbeats. ^{1 5 6 7 8}

Who Is on the Research Team?

George Crossley, MD

Principal Investigator

Vanderbilt University (LEADR)

Pugazhendhi Vijayaraman, MD

Principal Investigator

Geisinger Medical Center (LEADR LBBAP)

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Next Generation ICD lead

Trial Overview

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.

How Is the Trial Designed?

Group I: Intervention/Treatment (LEADR) Experimental Treatment 1 Intervention

Patients will be implanted with a Next Generation ICD Lead and undergo required electrical testing

Group II: Intervention/Treatment (LEADR LBBAP) Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Medtronic Cardiac Rhythm and Heart Failure

Lead Sponsor

Trials

206

Recruited

137,000+

Geoff Martha

Medtronic Cardiac Rhythm and Heart Failure

Chief Executive Officer since 2020

MBA from University of Minnesota

Dr. Kweli Thompson

Medtronic Cardiac Rhythm and Heart Failure

Chief Medical Officer since 2022

MD from Harvard Medical School

Published Research Related to This Trial

In a study of 37 patients with refractory ventricular arrhythmias, the latest generation of implantable cardioverter-defibrillators (ICDs) was successfully implanted without thoracotomy in 97% of cases, demonstrating a significant improvement in the ease of the procedure.

During a mean follow-up of 5 months, 62% of patients had their ICDs activated, with 96% receiving appropriate shocks, indicating the ICD's effectiveness in managing life-threatening arrhythmias and potentially reducing hospital readmissions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Initial clinical results with a novel implantable cardioverter-defibrillator: a prospective evaluation in 3 Swiss university hospitals]. Osswald, S., Candinas, R., Fuhrer, J.[2006]

Recent advancements in implantable cardioverter-defibrillator (ICD) lead technology have improved their safety and efficacy in detecting and treating life-threatening heart rhythms, but some designs have led to increased lead failures, particularly in the Medtronic Sprint Fidelis® and St. Jude Medical Riata® models.

The review highlights the need for better registries to track lead performance and emphasizes that optimal ICD therapy depends on using reliable leads and having experienced medical professionals for implantation, especially for patients at risk of ventricular tachyarrhythmias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[ICD leads]. Israel, CW., Sheta, MK.[2018]

In a study using a Markov model to evaluate lead management strategies for Riata and Riata ST ICD leads, capping a malfunctioning lead while implanting a new one showed the highest average life expectancy at 134.5 months, closely followed by lead extraction at 134.0 months.

The analysis indicated that there is no benefit to routine fluoroscopic screening for lead externalization, and when considering risks, lead extraction is preferred if the risk of nonarrhythmic death from leaving a lead in place exceeds 0.05% per year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal management of Riata leads with no known electrical abnormalities or externalization: a decision analysis. Pokorney, SD., Zhou, K., Matchar, DB., et al.[2015]

A study of 374,132 patients receiving implantable cardioverter-defibrillators (ICDs) found that the four most commonly implanted high-energy leads had excellent long-term safety, with lead failure rates ranging from 97.7% to 98.9% freedom from failure at 5 years.

No significant differences in lead survival rates were observed among the four leads, indicating that contemporary ICD leads are safe and effective for patients, with no safety alerts triggered during the study period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active Surveillance of the Implantable Cardioverter-Defibrillator Registry for Defibrillator Lead Failures. Resnic, FS., Majithia, A., Dhruva, SS., et al.[2021]

The use of implantable cardioverter-defibrillators (ICDs) significantly reduces the risk of sudden cardiac death, but complications from lead failures are becoming a growing concern as their use increases for primary prevention.

Data from a large registry indicated a 2.5% incidence of lead malfunction requiring surgical revision over 5 years, with a 20% recurrence rate of malfunction after replacement, highlighting the need for improved lead design and monitoring to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implantable cardioverter-defibrillator lead failure: how weak is the link? Brinker, JA.[2008]

In a study involving 7,497 patients with St. Jude Medical Riata ICD leads followed for a median of 22 months, the incidence of lead-related adverse events was found to be very low, with conductor fracture at 0.09%, insulation damage at 0.13%, dislodgement at 0.88%, and perforation at 0.31%.

These results suggest that lead-related complications requiring revision, extraction, or replacement are rare, indicating a favorable safety profile for Riata ICD leads over the follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of the St. Jude Medical Riata leads. Epstein, AE., Baker, JH., Beau, SL., et al.[2022]

In a study of 36 patients with Sprint Fidelis (SF) ICD leads followed for an average of 76 months, 38.9% of patients died, but none of the deaths were linked to lead failure, indicating a level of safety in the management of these patients.

Lead failure was identified in 5 cases (13.9%), with symptoms including inappropriate shocks and loss of stimulation; however, the implementation of management guidelines for SF leads was effective, as 4 out of 5 failed leads were successfully replaced.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sprint Fidelis implantable cardioverter-defibrillators lead patient management and survival: Single center study. Grabowski, M., Rokicki, JK., Gajda, S., et al.[2018]

The LEADR study is evaluating a new, small-diameter, lumenless defibrillator lead designed to improve long-term reliability and reduce the risk of lead failure, a common issue with traditional ICD leads.

This multi-center clinical study will involve between 500 to 900 patients over a minimum of 18 months, using innovative Bayesian methods and virtual patient data to assess the safety and efficacy of the new lead design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and design of the Lead Evaluation for Defibrillation and Reliability study: Safety and efficacy of a novel ICD lead design. Crossley, GH., Sanders, P., De Filippo, P., et al.[2023]

In a study of 73 patients implanted with the Biotronik LinoxSmart DX ICD lead, the mean P wave amplitude improved significantly over one year, indicating enhanced atrial sensing capabilities.

However, the rate of appropriate atrial sensing decreased from 100% at implantation to 89% after 12 months, suggesting a need for further research to assess the long-term reliability of this device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of the LinoxSmart DX ICD lead from a single center experience. Marai, I., Milman, A., Diamante, R., et al.[2020]

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/pii/S2405500X25005298

Contemporary Implantable Cardioverter-Defibrillator Benefit

Secondary prevention ICD-indicated patients had a higher 10-year cumulative incidence of first appropriate shock (41% vs 32%), ATP (51% vs 40%), ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10107290/

Safety and efficacy of a novel ICD lead design - PubMed Central

The primary efficacy objective is to demonstrate that defibrillation efficacy exceeds a threshold of 88% in a subset of patients. The defibrillation endpoint ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04863664

Lead EvaluAtion for Defibrillation and Reliability (LEADR ...

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 ...

4.

heartrhythmjournal.com

heartrhythmjournal.com/article/S1547-5271(24)02741-3/fulltext

Where do we stand, and what will the future hold?

Conclusion. During the past 15 years, S-ICD therapy has proved to be an effective and safe alternative for patients without pacing indications, ...

5.

academic.oup.com

academic.oup.com/europace/article/27/3/euaf044/8047336

Evaluation of a second-generation intercostal extravascular ...

We report 3-month safety and performance outcomes with a second-generation intercostal EV-ICD lead paired with standard, commercially available ICD pulse ...

6.

ahajournals.org

ahajournals.org/doi/10.1161/01.cir.98.7.663

Adverse Events With Transvenous Implantable ...

The second most common adverse event was lead/ICD-can dislodgment, which was observed in 23 instances; 1 patient experienced dislodgment twice. The electrode ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666501824002290

Remarkably high and accelerating failure rate of a widely ...

Generally, ICD systems including electrodes are considered to be safe, with an accepted annual lead failure rate of 0.5%.

8.

accessdata.fda.gov

accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=22911866&pc=DXY

MAUDE Adverse Event Report: MEDTRONIC, INC ...

There were three patient deaths; two died of heart failure and one due to bacteremia caused by a lead infection.There were six patients who ...