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Single-Lead ICD that spots hidden heart rhythm problems

NCT ID NCT04869527

Disease control Sponsor: Biotronik SE & Co. KG 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This trial tests a special implantable cardioverter-defibrillator (ICD) that uses a single lead to sense both heart chambers, aiming to detect atrial fibrillation and other arrhythmias early. It includes 56 people who need a single-chamber ICD and are in normal sinus rhythm at the start. The device automatically sends data to a remote monitoring center, which may help doctors manage heart conditions sooner.

What this could mean

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

Active substance
BIOTRONIK ICD with DX Technology
What this could lead to
If successful, this approach could improve early detection of atrial fibrillation and reduce complications in people with single-chamber ICDs.
What could go wrong
This is a small, early-stage study with 56 participants, so results may not apply to all patients. The device may not detect all arrhythmias or could have technical issues.

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.

Participants

56 people

The number who actually took part.

Started

Nov 2021

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Patients requiring an ICD implant

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: 1. Indication for implanting of a single chamber ICD (primary or secondary prevention) according to current guidelines; 2. Sustained sinus rhythm as the current prevalent atrial rhythm; 3. Planned de novo implantation with a BIOTRONIK single chamber DX ICD system; 4. Patient is able to understand the nature of study and to provide written informed consent; 5. Patient is willing and able to perform all follow up visits at the study site; 6. Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept. Exclusion Criteria: 1. Age \< 18 years 2. Any limitation to contractual capability; 3. Female patients who are pregnant or breast feeding or planning pregnancy during the course of the study; 4. Known active malignant disease or recovered from malignant disease within 2 years prior to enrollment; 5. Life expectancy \< 2 years; 6. Patient is participating in any other interventional clinical investigation.

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac cardiac rhythm disease

As listed by the trial registrant

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

Arrhythmias, cardiac

Contacts and locations

Locations

  • BIOTRONIK Coml Médica LTDA

    São Paulo, 01533-000, Brazil

  • Santa Casa de Misericórdia de Porto Alegre - Brugada Institute

    Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

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