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Post-market Clinical Follow-up Data Collection From Procedures With BIOTRONIK EP Products

RECRUITINGSponsored by Biotronik SE & Co. KG
Actively Recruiting
SponsorBiotronik SE & Co. KG
Started2023-01-16
Est. completion2030-07
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05560958

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

Cardiac ArrhythmiaHeart Disease

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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