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BIO|COLLECT-EP: Post-market Clinical Follow-up Data Collection From Procedures With BIOTRONIK EP Products

Sponsor
Biotronik SE & Co. KG (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05560958
Collaborator
(none)
280
Enrollment
1
Location
30.1
Anticipated Duration (Months)
9.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: BIOTRONIK EP catheters (AlCath, MultiCath, ViaCath), external devices (Qubic RF, Qubic Stim, Qiona) and transseptal sheaths (Senovo bi-flex)

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
280 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Post-market Clinical Follow-up Data Collection From Procedures With BIOTRONIK EP Products
Actual Study Start Date :
Oct 28, 2022
Anticipated Primary Completion Date :
Apr 30, 2025
Anticipated Study Completion Date :
Apr 30, 2025

Outcome Measures

Primary Outcome Measures

  1. Rate of Device deficiencies [During EP procedure]

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

  2. Rate of Peri-procedural adverse device effects for each investigational device type [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

  3. Rate of Post-procedural adverse device effects [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

  4. Percentage of Clinical benefit confirmations per number of use cases [At the time of procedure]

    Clinical benefit at the time of procedure for each investigational device type

Other Outcome Measures

  1. Procedure setting (related to used BIOTRONIK EP products and competitor products) [Intervention]

    Type of procedure, type of catheter models, recording system, RF ablation generator, irrigation pump, stimulator, 3D system, patient cable

  2. Procedural parameters [Intervention]

    Fluoroscopy time, Procedure duration, duration of RF energy delivery, date and time of procedure

  3. Patient details [Baseline]

    demographics, medical history, and concomitant cardiovascular medication

  4. Device performance [Intervention]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Städtisches Krankenhaus Friedrichshafen Friedrichshafen Germany 88048

Sponsors and Collaborators

  • Biotronik SE & Co. KG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT05560958
Other Study ID Numbers:
  • EP035
First Posted:
Sep 30, 2022
Last Update Posted:
Dec 16, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Arrhythmias, Cardiac

Study Results

No Results Posted as of Dec 16, 2022