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Can we safely skip the shock test during heart device implant?

NCT ID NCT03495297

Knowledge-focused Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether it's safe to skip the defibrillation test when implanting a subcutaneous implantable cardioverter-defibrillator (S-ICD). The test involves purposely triggering a dangerous heart rhythm to make sure the device can stop it. About 965 people took part. The goal was to see if skipping the test leads to more failed shocks when the device is needed later.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
procedure: subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation with or without defibrillation testing
What this could lead to
If skipping the defibrillation test proves safe, future S-ICD implants could be simpler, faster, and less painful for patients.
What could go wrong
This is a completed study, but skipping the test might still miss some device issues. Results may not apply to all patients or devices.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

965 people

The number who actually took part.

Started

May 2018

Finished

Apr 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients who meet current guidelines for ICD therapy and intent to undergo a de novo implant procedure for an S-ICD * Patients must pass S-ICD screening per local routine * Patients over 18 years of age, willing and capable to give informed consent * Patients must be willing and capable of complying to follow up visits * Patient must be eligible for either DFT strategy per physician discretion Exclusion Criteria: * Patient with a life expectancy shorter than 12 months due to any medical condition * Patients known to be pregnant * Patients with intracardiac thrombus * Patients with atrial fibrillation without appropriate anticoagulation * Patients likely to undergo heart transplant within 12 months * Patients with LVAD * Patients with other contra-indications for DFT per physician's discretion

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Conditions

The condition(s) this trial relates to.

cardiac rhythm disease ventricular tachycardia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ventricular arrythmia

Contacts and locations

Locations

  • Academic Medical Center Amsterdam

    Amsterdam, Netherlands

  • Adventh Health System

    Orlando, Florida, 32803, United States

  • Albert Schweitzer Ziekenhuis

    Dordrecht, Netherlands

  • Asklepios Kliniken

    Hamburg, Germany

  • Barts Health NHS Trust of the Royal London Hospital

    London, EC1A 7BE, United Kingdom

  • Basildon and Thurrock Univerity Hospital NHS Foundation Trust

    Basildon, United Kingdom

  • Blackpool Victoria Hospital NHS Foundation Trust

    Blackpool, United Kingdom

  • Canisius Wilhelmina Ziekenhuis

    Nijmegen, Netherlands

  • Catharina Ziekenhuis

    Eindhoven, Netherlands

  • CorVita Science Foundation

    Chicago, Illinois, 60605, United States

  • Emory University Hospital

    Atlanta, Georgia, 30322, United States

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631, United States

  • Erlanger Health System

    Chattanooga, Tennessee, 37403, United States

  • Flevoziekenhuis

    Almere Stad, Netherlands

  • Heart and Chest Hospital NHS Foundation Trust

    Liverpool, United Kingdom

  • Icahn School of Medicine at Mount Sinaï

    New York, New York, 10029, United States

  • Isala Klinieken

    Zwolle, Netherlands

  • Manchester Heart Center, Manchester Royal Infirmary

    Manchester, M13 9WL, United Kingdom

  • Medisch Centrum Leeuwarden

    Leeuwarden, Netherlands

  • Mount Sinai Beth Israel

    New York, New York, 10003, United States

  • OLVG

    Amsterdam, Netherlands

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 7LE, United Kingdom

  • Royal Papworth Hospital NHS Foundation Trust

    Cambridge, United Kingdom

  • Sheffield Teaching Hospitals NHS Foundation Trust, Northern General Hospital

    Sheffield, United Kingdom

  • Spaarne Gasthuis

    Haarlem, Netherlands

  • St Antonius Ziekenhuis

    Nieuwegein, Netherlands

  • The Royal Wolverhampton NHS Trust, the New Cross Hospital

    Wolverhampton, United Kingdom

  • UMCG

    Groningen, Netherlands

  • Universitätsklinikum Mannheim

    Mannheim, Germany

  • Universitätsklinikum Schleswig-Holstein

    Kiel, Germany

  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck

    Lübeck, Germany

  • Universitätsklinikum Würzburg

    Würzburg, Germany

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