BIO|MASTER.Ilivia Family / Plexa

Heart Failure Clinical Trial

Official title:

BIO|MASTER.Ilivia Family / Plexa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02774616
• Other study ID #: TA111
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Heart Failure
• Tachyarrhythmia
• Tachycardia

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