ETPR: European TauroPace Registry - University of Schleswig-Holstein Prospective Observational Clinical Study

Sponsor

University of Kiel (Other)

Overall Status

Recruiting

CT.gov ID

NCT04735666

Collaborator

University of Luebeck (Other)

2,300

Enrollment

Locations

107.2

Anticipated Duration (Months)

460

Patients Per Site

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

University of Schleswig-Holstein Campus Kiel is sponsoring the European TauroPace Registry, a prospective, multi-centre, international clinical cohort study. This study will evaluate the ability of TauroPace™ CIED irrigation solution to reduce major Cardiac Implantable Electronic Device (CIED) infections in the first three months after any CIED related surgery procedure (following any CIED generator replacement, upgrade, downgrade revision, or de novo implant).

Condition or Disease	Intervention/Treatment	Phase
CIED Related Infection	Device: TauroPace™

Detailed Description

After inclusion of the patient, the CIED related surgical procedure is performed with TauroPace™. After the patient is discharged, follow-up takes place at the participating centre after one, three and twelve months. Endpoints are CIED infection, adverse events and incidents.

Additionally to the follow-up visits, participants will be trained to be aware of the clinical criteria for CIED infection as defined in 5.4. of the current study protocol. Participants will be told to call whenever the slightest signs of the mentioned criteria are observed or in any case of unusual or suspect indisposition. If the call gives indication for CIED infection, adverse events or incidents the participant calling will be examined in the ward by a cardiologist or cardiac surgeon with expertise in rhythm surgery. Decision on presence of CIED infection, adverse event or other incident will be made according to the respective examination results and the clinical criteria defined.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

2300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

European TauroPace Registry - University of Schleswig-Holstein Prospective Observational Clinical Study

Actual Study Start Date :

Feb 22, 2021

Anticipated Primary Completion Date :

Jan 30, 2023

Anticipated Study Completion Date :

Jan 30, 2030

Outcome Measures

Primary Outcome Measures

CIED infections [three months]
CIED infections occurring in an observation period after any CIED related surgery in different CIED using a regimen with surface disinfection of CIEDs.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Use of TauroPace™ is indicated and not contra-indicated according to its current Instructions For Use (IFU)
Participant is eligible for a CIED related surgery procedure.

Exclusion Criteria:

Age<18years
Participant incapable of signing Patient Informed Consent (mentally or physically) or does not sign.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Krankenhaus Landshut Achdorf	Landshut	Bavaria	Germany	84036
2	Helios Klinik Cuxhaven	Cuxhaven	Niedersachsen	Germany	27474
3	Helios Klinik Wesermarsch	Nordenham	Niedersachsen	Germany	26954
4	University Hospital Schleswig-Holstein	Kiel	Schleswig-Holstein	Germany	24105
5	The Great Western Hospital	Swindon	Wiltshire	United Kingdom	SN3 6BB

Sponsors and Collaborators

University of Kiel
University of Luebeck

Investigators

Principal Investigator: Hendrik Bonnemeier, PhD, University of Kiel - Medical Faculty

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prof. Dr. Hendrik Bonnemeier, Coordinating Investigator ETPR, University of Kiel

ClinicalTrials.gov Identifier:

NCT04735666

Other Study ID Numbers:

First Posted:

Feb 3, 2021

Last Update Posted:

Apr 14, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 14, 2022