Cardiac ArrhythmiaBIO|COLLECT-EPNCT05560958
Post-market Clinical Follow-up Data Collection From Procedures With BIOTRONIK EP Products
An observational study of Cardiac Arrhythmia, run by Biotronik SE & Co. KG at 1 site in Germany.
Trial summary
This data collection is designed to provide evidence for the safety, performance, and clinical benefit of BIOTRONIK's EP products. Additionally, residual risks will be monitored and newly emerging risks identified. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrhythmia
- What is being tested?
- BIOTRONIK EP catheters (AlCath, MultiCath, ViaCath), external devices (Qubic RF, Qubic Stim, Qiona) and transseptal sheaths (Senovo bi-flex)
- Type of treatment
- Medical device
- How many people
- 280 participants
- Where
- 1 siteGermany
- Study dates
- 16 Jan 2023to Jul 2030
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients indicated for diagnosis and treatment of intracardiac arrhythmias in an EP lab environment.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Immanuel Klinikum Bernau Herzzentrum Brandenburg
Bernau bei Berlin, Brandenburg, 16321
Christian Butter, Univ.-Prof. Dr. med., +49 (0) 3338-694610, christian.butter@immanuelalbertinen.de
About this study
This data collection is designed to provide evidence for the safety, performance, and clinical benefit of BIOTRONIK's EP products. Additionally, residual risks will be monitored and newly emerging risks identified.
Read the detailed description
In this study, data from routine care will be collected and evaluated to support regulatory post-market clinical follow-up demands under MDR as well as maintenance of the regulatory approval of the BIOTRONIK's EP product portfolio in the CE region. This is a prospective, observational, multi-center, international, open-label, non-randomized study that aims to provide evidence for the clinical safety, performance, and clinical benefit of BIOTRONIK's EP products. The patients participating in the study either receive a diagnostic or therapeutic catheter intervention, which are indicated for temporary transvenous application in patients with cardiac arrhythmias. They will be used in combination with external devices like RF generators, external pacemakers cardiac stimulators and / or irrigation pumps.
- Conditions
- Cardiac Arrhythmia
- Being tested
- BIOTRONIK EP catheters (AlCath, MultiCath, ViaCath), external devices (Qubic RF, Qubic Stim, Qiona) and transseptal sheaths (Senovo bi-flex)
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIOTRONIK EP catheters (AlCath, MultiCath, ViaCath), external devices (Qubic RF, Qubic Stim, Qiona) and transseptal sheaths (Senovo bi-flex)Device
Ablations and diagnostic catheters are indicated for temporary transvenous application in patients with cardiac arrhythmias during electrophysiology study (EPS) or catheter ablation interventions. They will be used in combination with external devices like RF generators, external pacemakers cardiac stimulators and / or irrigation pumps.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Device deficiencies
Device deficiencies for each investigational device type that occur during the EP procedures in patients, users or other persons
Measured: During EP procedure
Rate of Peri-procedural adverse device effects for each investigational device type
Peri-procedural adverse device effects for each investigational device type that occur in all patients until or at the 24-hour follow-up
Measured: Until or at 24-hour follow-up
Rate of Post-procedural adverse device effects
Post-procedural adverse device effects that occur in the AlCath group after the 24-hour follow-up until or at the 3- to 6-month follow-up
Measured: After the 24-hour follow-up until or at the 3- to 6-month follow-up
Percentage of Clinical benefit confirmations per number of use cases
Clinical benefit at the time of procedure for each investigational device type
Measured: At the time of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start16 Jan 2023
- Primary completionJul 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 280 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560958
- Sponsor's protocol ID
- EP035
- Acronym
- BIO|COLLECT-EP
- Status last verified
- Sep 2026
- First submitted
- 27 Sep 2022
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon resonable request by authors or other scientifc reasons, but requires explicit approval by the sponsor.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Clinical Follow-up Data Collection From Procedures With BIOTRONIK EP Products
- ClinicalTrials.gov ID
- NCT05560958
- Acronym / sponsor ID
- BIO|COLLECT-EP / EP035
- Conditions
- Cardiac Arrhythmia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 30 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This data collection is designed to provide evidence for the safety, performance, and clinical benefit of BIOTRONIK's EP products. Additionally, residual risks will be monitored and newly emerging risks identified.
Detailed description
In this study, data from routine care will be collected and evaluated to support regulatory post-market clinical follow-up demands under MDR as well as maintenance of the regulatory approval of the BIOTRONIK's EP product portfolio in the CE region. This is a prospective, observational, multi-center, international, open-label, non-randomized study that aims to provide evidence for the clinical safety, performance, and clinical benefit of BIOTRONIK's EP products. The patients participating in the study either receive a diagnostic or therapeutic catheter intervention, which are indicated for temporary transvenous application in patients with cardiac arrhythmias. They will be used in combination with external devices like RF generators, external pacemakers cardiac stimulators and / or irrigation pumps.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients indicated for diagnosis and treatment of intracardiac arrhythmias in an EP lab environment.
Key inclusion criteria (9 listed)
- 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 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIOTRONIK EP catheters (AlCath, MultiCath, ViaCath), external devices (Qubic RF, Qubic Stim, Qiona) and transseptal sheaths (Senovo bi-flex)Ablations and diagnostic catheters are indicated for temporary transvenous application in patients with cardiac arrhythmias during electrophysiology study (EPS) or catheter ablation interventions. They will be used in combination with external devices like RF generators, external pacemakers cardiac stimulators and / or irrigation pumps. | Device | – |
Primary outcome
Rate of Device deficiencies
Time frame: During EP procedure
Device deficiencies for each investigational device type that occur during the EP procedures in patients, users or other persons
Rate of Peri-procedural adverse device effects for each investigational device type
Time frame: Until or at 24-hour follow-up
Peri-procedural adverse device effects for each investigational device type that occur in all patients until or at the 24-hour follow-up
Rate of Post-procedural adverse device effects
Time frame: After the 24-hour follow-up until or at the 3- to 6-month follow-up
Post-procedural adverse device effects that occur in the AlCath group after the 24-hour follow-up until or at the 3- to 6-month follow-up
Percentage of Clinical benefit confirmations per number of use cases
Time frame: At the time of procedure
Clinical benefit at the time of procedure for each investigational device type
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Yes. Upon resonable request by authors or other scientifc reasons, but requires explicit approval by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrhythmia, run by Biotronik SE & Co. KG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annette Thiem, Dr. (+49 (0) 151 6890 ext. 1303, annette.thiem@biotronik.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Device deficiencies (time frame: During EP procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.