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Which heart device lead lasts longest in kids? study aims to find out

NCT ID NCT00335036

Disease control Sponsor: Charles Berul 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at two types of implantable cardioverter defibrillator (ICD) leads in children and patients with congenital heart disease. The goal was to see which lead type lasts longer without breaking and is easier to remove if needed. The trial was terminated early, so results are limited.

What this could mean

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

Active substance
implantable cardioverter defibrillator (ICD) leads
What this could lead to
If successful, this study could help doctors choose better ICD leads for children and heart disease patients, reducing the need for risky removal procedures.
What could go wrong
The study was terminated early, so results may be incomplete. It is also observational in nature, so it cannot prove that one lead type is definitively better.

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

748 people

The number who actually took part.

Start date

Jun 2006

Finished

Jan 2009

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

1 year to 55 years

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 will be eligible for study enrollment at the time of implantation of a new ICD and transvenous ICD lead. * All patients under the age of 21 years at the time of initial ICD implantation, or those patients with congenital heart disease and an indication for ICD implantation are eligible for participation. Exclusion Criteria: * Patients who have existing ICD leads in place. * Patients with expected survival less than 1 year. * Patients who cannot be expected to participate in follow-up visits. * Patients receiving an epicardial or subcutaneous ICD (without transvenous ICD lead).

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Conditions

The condition(s) this trial relates to.

cardiomyopathy congenital heart disease Death, Sudden, Cardiac long QT syndrome ventricular fibrillation ventricular tachycardia

As listed by the trial registrant

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

Cardiomyopathy Congenital heart disease Long QT syndrome Ventricular fibrillation Ventricular tachycardia

Contacts and locations

Locations

  • Children's Hospital Boston

    Boston, Massachusetts, 02115, United States

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