Post-market Clinical Follow-up Data Collection From Procedures With BIOTRONIK EP Products
ConditionCardiac Arrhythmia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBiotronik SE & Co. KG
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Indication for diagnostic or therapeutic EP intervention
BIOTRONIK catheter (AlCath, ViaCath, MultiCath, Khelix)
BIOTRONIK external device (Qubic Stim, Qubic RF, Qiona)
BIOTRONIK transseptal sheath (Senovo Bi-Flex)
Disqualifiers
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 population
Patients indicated for diagnosis and treatment of intracardiac arrhythmias in an EP lab environment.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
BIOTRONIK EP catheters (AlCath, MultiCath, ViaCath), external devices (Qubic RF, Qubic Stim, Qiona) and transseptal sheaths (Senovo bi-flex)
DeviceAblations 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Rate of Device deficiencies
Device deficiencies for each investigational device type that occur during the EP procedures in patients, users or other persons
Time frame
During EP procedure2
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
Time frame
Until or at 24-hour follow-up3
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
Time frame
After the 24-hour follow-up until or at the 3- to 6-month follow-up4
Percentage of Clinical benefit confirmations per number of use cases
Clinical benefit at the time of procedure for each investigational device type
Time frame
At the time of procedureOther outcomes
1
Procedure setting (related to used BIOTRONIK EP products and competitor products)
Type of procedure, type of catheter models, recording system, RF ablation generator, irrigation pump, stimulator, 3D system, patient cable
Time frame
Intervention2
Procedural parameters
Fluoroscopy time, Procedure duration, duration of RF energy delivery, date and time of procedure
Time frame
Intervention3
Patient details
demographics, medical history, and concomitant cardiovascular medication
Time frame
Baseline4
Device performance
e.g., successful insertion and advancing of catheter, successful stimulation and recording of intracardiac signals, RF energy application, removal, replacement/substitution of catheter, device used within its intended purpose
Time frame
InterventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov