Clinical trial NCT05560958: Post-market Clinical Follow-up Data Collection From Procedures With BIOTRONIK EP Products
Official title: Post-market Clinical Follow-up Data Collection From Procedures With BIOTRONIK EP Products
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Arrhythmia
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2022-09-30
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients indicated for diagnosis and treatment of intracardiac arrhythmias in an EP lab environment.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Device deficiencies
timeFrame: During EP procedure
measure: Rate of Peri-procedural adverse device effects for each investigational device type
timeFrame: Until or at 24-hour follow-up
measure: Rate of Post-procedural adverse device effects
timeFrame: After the 24-hour follow-up until or at the 3- to 6-month follow-up
measure: Percentage of Clinical benefit confirmations per number of use cases
timeFrame: At the time of procedure
Secondary outcomes:
Other outcomes:
measure: Procedure setting (related to used BIOTRONIK EP products and competitor products)
timeFrame: Intervention
measure: Procedural parameters
timeFrame: Intervention
measure: Patient details
timeFrame: Baseline
measure: Device performance
timeFrame: Intervention
Locations:
city: Friedrichshafen
country: Germany
facility: Städtisches Krankenhaus Friedrichshafen
Study officials:
References: