Post-market Clinical Follow-up Data Collection From Procedures With BIOTRONIK EP Products
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiac Arrhythmia
- Sponsor
- Biotronik SE & Co. KG
- Enrollment
- 280
- Locations
- 1
- Primary Endpoint
- Rate of Device deficiencies
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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
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
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