BIO|MASTER.Ilivia Family / Plexa

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

Study Overview

• Status: Completed
• Conditions: Heart Failure; Tachyarrhythmia
• Intervention / Treatment: Device: Ilivia ICD Family; Device: Plexa ICD lead

• Study Type: Interventional
• Enrollment (Actual): 292
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Ilivia ICD Family; Implant of the new Ilivia ICD Family. Device measurements, pre-defined programming and Adverse Event Reporting	Device: Ilivia ICD Family; pre-defined device programming, measurements and follow-up schedule
Other: Plexa ICD lead; Implant of the new Plexa ICD lead. Device measurements and Adverse Event Reporting	Device: Plexa ICD lead; predefined follow-up schedule
Other: Ilivia ICD and Plexa lead; Implant of the new Ilivia ICD Family and the new Plexa lead. Device measurements, pre-defined programming and Adverse Event Reporting	Device: Ilivia ICD Family; pre-defined device programming, measurements and follow-up schedule; Device: Plexa ICD lead; predefined follow-up schedule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Biotronik SE & Co. KG
• Investigators: Study Chair: Christian Sticherling, Prof. Dr., Universitätsspital Basel

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: May 13, 2016
• First Submitted That Met QC Criteria: May 16, 2016
• First Posted (Estimate): May 17, 2016

Study Record Updates

• Last Update Posted (Actual): May 22, 2019
• Last Update Submitted That Met QC Criteria: May 10, 2019
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia
• Other Study ID Numbers: TA111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO