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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02774616
Other study ID # TA111
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2016
Est. completion date March 2018

Study information

Verified date July 2018
Source Biotronik SE & Co. KG
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Post-Market Clinical Follow-up of the new Ilivia ICD Family and the new Plexa right ventricular lead to fulfill requirements by the notified body and to support regulatory approval outside of the CE region


Recruitment information / eligibility

Status Completed
Enrollment 292
Est. completion date March 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Standard indication for ICD or CRT-D therapy according to clinical practice

- De novo implantation or upgrade/exchange (group A only) from existing ICD, CRT-D or pacemaker implant

- Patient is able to understand the nature of the clinical investigation and provides written informed consent

- Patient is able and willing to complete all routine study visits at the investigational site

- Patient accepts Home Monitoring concept

- Age = 18 years

Exclusion Criteria:

- Contraindication to ICD or CRT-D therapy, respectively

- For CRT-D patients in group A only: physician not willing to activate MultiPole Pacing in the patient

- Cardiac surgical procedure planned within 6 months after implantation (including also interventional procedures like ablation, valve replacement etc.). Procedures to occur during or prior to implantation are not exclusionary.

- Expected to receive heart transplant or ventricular assist device within 6 months

- Life expectancy less than 6 months

- Participation in any other interventional clinical investigation

- Pregnant or breastfeeding at time of enrollment

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Ilivia ICD Family
pre-defined device programming, measurements and follow-up schedule
Plexa ICD lead
predefined follow-up schedule

Locations

Country Name City State
Australia Liverpool Hospital Liverpool
Australia Nambour General Hospital Nambour
Austria Universitätsklinikum St. Pölten St. Pölten
Denmark Odense University Hospital Odense
France CHU Brest Brest
Germany Hufeland Klinikum GmbH Bad Langensalza
Germany HDZ NRW Bad Oeynhausen Bad Oeynhausen
Germany Städtisches Klinikum Brandenburg GmbH Brandenburg
Germany Universitätsklinikum Erlangen Erlangen
Germany Universitätsklinikum Essen Essen
Germany Universitätsklinikum Freiburg Freiburg
Germany SRH Wald-Klinikum Gera GmbH Gera
Germany Westpfalz-Klinikum Kaiserslautern Kaiserslautern
Germany Hegau-Bodensee-Klinikum Singen Singen
Germany Universitätsklinikum Würzburg Würzburg
Israel Chaim Sheba Medical Center Ramat Gan
Israel Tel Aviv Sourasky Medical Center Tel Aviv
Latvia Pauls Stradins Clinical University Hospital Riga
Singapore National Heart Center Singapore Singapore
Spain Hospital de Bellvitge Barcelona
Spain Hospital de Donostia San Sebastian
Spain Hospital Universitario Virgen de Macarena Sevilla
Switzerland Universitätsspital Basel Basel
Switzerland Inselspital Bern Bern
Switzerland Kantonspital Luzern Luzern

Sponsors (1)

Lead Sponsor Collaborator
Biotronik SE & Co. KG

Countries where clinical trial is conducted

Australia,  Austria,  Denmark,  France,  Germany,  Israel,  Latvia,  Singapore,  Spain,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ilivia Family Related SADE-free Rate Through 3 Months This endpoint measures the percentage of patients without serious adverse device effect (SADE) related to the ICD device 3 months
Primary Plexa Related SADE-free Rate Through 6 Months This endpoint measures the percentage of patients without serious adverse device effect (SADE) related to the "Plexa" lead 6 months
Secondary Percentage of Patients With Successful Fast Ventricular Arrhythmia Conversion by ATP One-shot at 6-month Follow-up Of all patients with spontaneous ventricular arrhythmia detected in the VF zone, and treated by "ATP-one-shot", the percentage of patients with at least one successful termination will be determined 6 months
Secondary Rate of Appropriate Right Ventricular Sensing at 3-month Follow-up The investigator is asked whether the sensing function of the Pleaxa lead in the right ventricle is appropriate 3 months
Secondary Rate of Appropriate Right Ventricular Pacing at the 3 Months Follow-up The investigator is asked whether the pacing function of the Pleaxa lead in the right ventricle is appropriate 3 months
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