Defibrillator Lead for Rapid Heartbeat

Recruiting at 123 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

998 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

Is 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. ^{1 2 5 6 7}

How 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. ^{1 2 5 8 9}

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.

Research Team

George Crossley, MD

Principal Investigator

Vanderbilt University (LEADR)

Pugazhendhi Vijayaraman, MD

Principal Investigator

Geisinger Medical Center (LEADR LBBAP)

Eligibility 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.

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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]

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]

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]

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 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]

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]

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]

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]

References

1. United States 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. [2023]

2. Poland pubmed.ncbi.nlm.nih.gov

Sprint Fidelis implantable cardioverter-defibrillators lead patient management and survival: Single center study. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

[Initial clinical results with a novel implantable cardioverter-defibrillator: a prospective evaluation in 3 Swiss university hospitals]. [2006]

4. England pubmed.ncbi.nlm.nih.gov

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

5. Germany pubmed.ncbi.nlm.nih.gov

[ICD leads]. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Performance of the St. Jude Medical Riata leads. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Active Surveillance of the Implantable Cardioverter-Defibrillator Registry for Defibrillator Lead Failures. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Optimal management of Riata leads with no known electrical abnormalities or externalization: a decision analysis. [2015]

9. Netherlands pubmed.ncbi.nlm.nih.gov

The efficacy of the LinoxSmart DX ICD lead from a single center experience. [2020]