S-ICD Implant Without Defibrillation Testing for Ventricular Arrhythmia

(PRAETORIAN-DFT Trial)

Not currently recruiting at 33 trial locations

Overseen By Reinoud E Knops, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Disqualifiers: Pregnancy, Intracardiac thrombus, Atrial fibrillation, Heart transplant, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether implanting a subcutaneous implantable cardioverter defibrillator (S-ICD) without a defibrillation test is as effective as doing it with the test. S-ICDs treat dangerous heart rhythms without requiring wires in the heart. The study involves two groups: one will receive the device without the test, while the other will undergo the test. Suitable candidates are those who need an ICD (a device to help control irregular heartbeats) and are prepared to have an S-ICD implanted. As an unphased trial, this study offers patients the chance to contribute to important research that could simplify future S-ICD procedures.

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 trial coordinators or your doctor.

What prior data suggests that this S-ICD implantation method is safe?

Research has shown that the S-ICD, a type of heart device, is generally safe for individuals with heart rhythm problems. One study found that 93.4% of these devices and 99.3% of their components functioned without issues, surpassing the 85% safety goal set by researchers.

Another study demonstrated that S-ICDs can reduce the risk of death from an irregular heartbeat by up to 54%. Some individuals required the device to use more power for proper function, which was related to its placement in the body.

Overall, receiving an S-ICD without testing its shock function appears well-tolerated, with few complications. For those considering joining a trial, these findings suggest that the procedure is generally safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The treatment under study, the S-ICD implant without defibrillation testing, is unique because it eliminates the need for defibrillation testing during the implantation procedure. Traditional treatments for ventricular arrhythmias often involve defibrillation testing to ensure the device can effectively manage abnormal heart rhythms, which can be stressful and risky for patients. By skipping this step, the S-ICD implant aims to reduce procedural risks and discomfort while still providing effective protection against dangerous arrhythmias. Researchers are excited about this approach because it has the potential to simplify the procedure, making it safer and more comfortable for patients without compromising on efficacy.

What evidence suggests that S-ICD implantation without defibrillation testing is effective for ventricular arrhythmia?

Research has shown that the subcutaneous implantable cardioverter defibrillator (S-ICD) effectively treats dangerous fast heart rhythms, known as ventricular arrhythmias. The EFFORTLESS registry found that the device successfully delivered shocks 98% of the time over five years. Specifically, 99.5% of patients experienced successful treatment of abnormal heart rhythms when the device was implanted. In this trial, participants will be assigned to one of two groups: one group will undergo S-ICD implantation without defibrillation testing, while the other group will have the implantation with defibrillation testing. The S-ICD is also considered a safe option for individuals who do not require a device to assist with slow heart rates. While it does not aid with slow heart rates or heart failure, it has a strong track record in managing fast, dangerous heart rhythms. ^{1 2 6 7 8}

Who Is on the Research Team?

Reinoud E Knops, MD, PhD

Principal Investigator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need a new subcutaneous implantable cardioverter defibrillator (S-ICD) and meet current guidelines for ICD therapy. They must be able to consent, follow up on visits, pass S-ICD screening, and not have conditions like heart failure devices (LVAD), short life expectancy, pregnancy, intracardiac thrombus or planned heart transplant.

Inclusion Criteria

I am willing and able to attend all follow-up visits.

My doctor agrees I can try the DFT strategy.

Patients must pass S-ICD screening per local routine

Exclusion Criteria

You have a left ventricular assist device (LVAD).

You are expected to have a heart transplant within the next 12 months.

I have atrial fibrillation and am not on blood thinners.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

S-ICD Implantation

Participants undergo S-ICD implantation with or without defibrillation testing

1 day

1 visit (in-person)

Immediate Post-Implant Monitoring

Participants are monitored for complications and device functionality immediately after implantation

24 hours

Follow-up

Participants are monitored for safety, efficacy, and complications related to the S-ICD over an extended period

40 months

What Are the Treatments Tested in This Trial?

Interventions

• S-ICD Implantation

Trial Overview

The study compares two ways of implanting an S-ICD: one with a defibrillation test to check its function and another without the test. The main goal is to see if skipping the test does not lead to more failed first shocks during real arrhythmia episodes.

How Is the Trial Designed?

Group I: S-ICD Implant without defibrillation test Experimental Treatment 1 Intervention

Patients undergoing de novo S-ICD implantation without induction of VF and defibrillation testing post-implant

Group II: S-ICD Implant with defibrillation test Active Control 1 Intervention

Patients undergoing de novo S-ICD implantation including induction of VF and defibrillation testing post-implant

Who Is Running the Clinical Trial?

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Lead Sponsor

Trials

722

Recruited

2,726,000+

Boston Scientific Corporation

Industry Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Published Research Related to This Trial

The implantable cardioverter defibrillator (ICD) has proven to be more effective than traditional anti-arrhythmic therapies in reducing overall and cardiac mortality in patients at high risk for life-threatening arrhythmias, based on several randomized trials.

Recent advancements in ICD technology allow for more accurate detection of dangerous heart rhythms and offer various therapy options, including painless pacing and low-energy cardioversion, making the implantation process simpler and more efficient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The implantable cardioverter defibrillator: technology, indications, and impact on cardiovascular survival. Bhatia, A., Cooley, R., Berger, M., et al.[2004]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12292647/

Insights from the GASP Registry - PMC

Although the S-ICD does not provide pacing for bradycardia or heart failure, it has shown efficacy in treating ventricular arrhythmias while ...

2.

acc.org

acc.org/Latest-in-Cardiology/Journal-Scans/2022/02/09/15/51/Subcutaneous-ICDs-Long-Term

Subcutaneous ICD Long-Term Efficacy and Outcomes

In the EFFORTLESS registry, the S-ICD maintained a high level of shock efficacy of 98% at 5 years. During the follow-up of 5 years, only 2% of ...

3.

heartrhythmjournal.com

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

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

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

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/28797351/

Implant and Midterm Outcomes of the Subcutaneous ...

At implant, 99.5% of patients had a successful conversion of induced ventricular tachycardia or ventricular fibrillation. The 1- and 5-year ...

5.

jacc.org

jacc.org/doi/10.1016/j.jacc.2023.05.057

Subcutaneous ICD in Congenital Heart Disease

The 1-year, 2-year, and 5-year incidences of appropriate S-ICD shocks were 13.0%, 16.8%, and 37.5% in patients with CHD vs 5.2%, 9.1%, and 16.7% ...

6.

jacc.org

jacc.org/doi/10.1016/j.jacc.2023.05.037

Long-Term Safety and Efficacy of the Subcutaneous ...

Complication-free rates were observed in 93.4% for the S-ICD device and 99.3% for the S-ICD lead, rates that exceeded the 85% performance goals.

7.

ahajournals.org

ahajournals.org/doi/10.1161/circulationaha.113.003042

Safety and Efficacy of a Totally Subcutaneous Implantable ...

Randomized, multicenter studies have shown a relative risk reduction in total mortality of up to 54% and an arrhythmic mortality reduction of ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S0735109715007573

2-Year Results From a Pooled Analysis of the IDE Study ...

The S-ICD annual mortality rate of 1.6% and 2-year mortality rate of 3.2% in the pooled data compares favorably with recent ICD trials. With controlled ...