NCT05560958

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for all trials

Timeline
49mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Jan 2023Jul 2030

First Submitted

Initial submission to the registry

September 27, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 30, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

January 16, 2023

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

7.5 years

First QC Date

September 27, 2022

Last Update Submit

September 16, 2025

Conditions

Cardiac Arrhythmia

Outcome Measures

Primary Outcomes (4)

  • Rate of Device deficiencies

    Device deficiencies for each investigational device type that occur during the EP procedures in patients, users or other persons

    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

    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

    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

    At the time of procedure

Other Outcomes (4)

  • Procedure setting (related to used BIOTRONIK EP products and competitor products)

    Intervention

  • Procedural parameters

    Intervention

  • Patient details

    Baseline

  • +1 more other outcomes

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Städtisches Krankenhaus Friedrichshafen

Friedrichshafen, 88048, Germany

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Ines Danzke

CONTACT

+49 (0) 151 6890ines.danzke@biotronik.com

Annette Thiem, Dr.

CONTACT

+49 (0) 151 6890annette.thiem@biotronik.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2022

First Posted

September 30, 2022

Study Start

January 16, 2023

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

July 1, 2030

Last Updated

September 17, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Upon resonable request by authors or other scientifc reasons, but requires explicit approval by the sponsor.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
The data will become available with uploading the results to clinical trial.gov. The data will be available as long as the study documents are archived.
Access Criteria
On demand; in case of request by an author or in case of scientific reasons, but requires explicit approval by the sponsor.

Locations

DE(1)