Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Heart device safety check: 280 patients monitored

NCT ID NCT05560958

Knowledge-focused 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 study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 09, 2026 · Updated 2 times

Summary

This study is collecting information from 280 people who need a heart rhythm procedure using BIOTRONIK catheters, external devices, or sheaths. The goal is to track how well the devices work and any problems that may happen during or shortly after the procedure. It is a routine safety check, not a test of a new treatment.

What this could mean

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

Active substance
BIOTRONIK EP catheters, external devices, and transseptal sheaths
What this could lead to
If successful, this study will confirm that these devices are safe and work well for treating heart rhythm problems.
What could go wrong
This is an observational data collection, not a test of a new treatment. It may not lead to any new therapies or changes in practice.

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

About 280 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Jul 2030

An estimate. End dates often move.

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 indicated for diagnosis and treatment of intracardiac arrhythmias in an EP lab environment.

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: * Indication for diagnostic or therapeutic EP intervention * EP intervention is planned to involve the use of BIOTRONIK EP products from at least 2 of the 3 following categories: * BIOTRONIK catheter (AlCath, ViaCath, MultiCath, Khelix) * BIOTRONIK external device (Qubic Stim, Qubic RF, Qiona) * BIOTRONIK transseptal sheath (Senovo Bi-Flex) * BIOTRONIK EP product is planned to be used within its intended purpose * Ability to understand the nature of the study * Willingness to provide written informed consent * Ability and willingness to perform all follow-up visits at the study site Exclusion Criteria: * Age less than 18 years * Pregnant or breastfeeding * Prior participation in this study with performed EP procedure * Participation in an interventional clinical investigation in parallel to the BIO\|COLLECT.EP study

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Cardiac arrhythmia are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac ventricular arrhythmias due to cardiac ryanodine receptor calcium release deficiency syndrome

As listed by the trial registrant

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

Cardiac arrhythmia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Immanuel Klinikum Bernau Herzzentrum Brandenburg

    RECRUITING

    Bernau bei Berlin, Brandenburg, 16321, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.