S-ICD Implant Without Defibrillation Testing for Ventricular Arrhythmia

(PRAETORIAN-DFT Trial)

Recruiting at 32 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

965 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will test the hypothesis that implantation of a subcutaneous implantable cardioverter defibrillator (S-ICD) without performing a defibrillation test is non-inferior to S-ICD implant with a defibrillation test with regards to the primary endpoint failed first shock in a spontaneous arrhythmia episode when implant position is confirmed with PRAETORIAN score.

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.

Is the S-ICD implant generally safe for humans?

The S-ICD (subcutaneous implantable cardioverter-defibrillator) is considered generally safe for humans, as it avoids complications related to traditional ICDs (implantable cardioverter-defibrillators) that use leads inside blood vessels. Studies have shown that the S-ICD reduces common complications and is effective in treating life-threatening heart rhythm problems. ^{1 2 3 4 5}

How does the S-ICD Implantation treatment differ from other treatments for ventricular arrhythmia?

The S-ICD Implantation is unique because it is a subcutaneous device that does not require leads to be placed inside the heart or blood vessels, unlike traditional implantable cardioverter-defibrillators (ICDs). This reduces the risk of complications associated with intravascular leads, such as infections or lead dislodgement. ^{6 7 8 9 10}

What data supports the effectiveness of the S-ICD Implantation treatment for ventricular arrhythmia?

The S-ICD (subcutaneous implantable cardioverter-defibrillator) is designed to treat dangerous heart rhythms by delivering a shock to the heart, similar to traditional ICDs (implantable cardioverter defibrillators), which have been shown to reduce the risk of death in patients with life-threatening heart rhythm problems. The EFFORTLESS study is collecting data on the outcomes of patients with S-ICDs, indicating ongoing research into its effectiveness. ^{11 12 13 14 15}

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. Netherlands pubmed.ncbi.nlm.nih.gov

The implantable cardioverter defibrillator: technology, indications, and impact on cardiovascular survival. [2004]

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

Implant and Midterm Outcomes of the Subcutaneous Implantable Cardioverter-Defibrillator Registry: The EFFORTLESS Study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Defibrillation Testing During Defibrillator Implantation. [2020]

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

Suitability for subcutaneous defibrillator implantation: results based on data from routine clinical practice. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Defibrillation testing of the implantable cardioverter defibrillator: when, how, and by whom? [2020]

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

Safety and efficacy of a totally subcutaneous implantable-cardioverter defibrillator. [2022]

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

Subcutaneous implantable cardioverter-defibrillator and defibrillation testing: A propensity-matched pilot study. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

[Journey of the S‑ICD to first-line therapy]. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Is defibrillation testing of ICDs necessary? [2021]

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

Postapproval Study of a Subcutaneous Implantable Cardioverter-Defibrillator System. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Subcutaneous chronic implantable defibrillation systems in humans. [2021]

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

Defibrillation testing is mandatory in patients with subcutaneous implantable cardioverter-defibrillator to confirm appropriate ventricular fibrillation detection. [2018]

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

Use of a discrimination algorithm to reduce inappropriate shocks with a subcutaneous implantable cardioverter-defibrillator. [2016]

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

Subcutaneous implantable cardioverter-defibrillator: First single-center experience with other cardiac implantable electronic devices. [2022]

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

Use and outcomes of subcutaneous implantable cardioverter-defibrillator (ICD) after transvenous ICD extraction: An analysis of current clinical practice and a comparison with transvenous ICD reimplantation. [2020]