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BIO|MASTER.Ilivia Family / Plexa

Primary Purpose

Heart Failure, Tachyarrhythmia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Ilivia ICD Family
Plexa ICD lead
Sponsored by
Biotronik SE & Co. KG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Liverpool Hospital
  • Nambour General Hospital
  • Universitätsklinikum St. Pölten
  • Odense University Hospital
  • CHU Brest
  • Hufeland Klinikum GmbH
  • HDZ NRW Bad Oeynhausen
  • Städtisches Klinikum Brandenburg GmbH
  • Universitätsklinikum Erlangen
  • Universitätsklinikum Essen
  • Universitätsklinikum Freiburg
  • SRH Wald-Klinikum Gera GmbH
  • Westpfalz-Klinikum Kaiserslautern
  • Hegau-Bodensee-Klinikum Singen
  • Universitätsklinikum Würzburg
  • Chaim Sheba Medical Center
  • Tel Aviv Sourasky Medical Center
  • Pauls Stradins Clinical University Hospital
  • National Heart Center Singapore
  • Hospital de Bellvitge
  • Hospital de Donostia
  • Hospital Universitario Virgen de Macarena
  • Universitätsspital Basel
  • Inselspital Bern
  • Kantonspital Luzern

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Ilivia ICD Family

Plexa ICD lead

Ilivia ICD and Plexa lead

Arm Description

Implant of the new Ilivia ICD Family. Device measurements, pre-defined programming and Adverse Event Reporting

Implant of the new Plexa ICD lead. Device measurements and Adverse Event Reporting

Implant of the new Ilivia ICD Family and the new Plexa lead. Device measurements, pre-defined programming and Adverse Event Reporting

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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
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

Full Information

First Posted
May 13, 2016
Last Updated
May 10, 2019
Sponsor
Biotronik SE & Co. KG
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1. Study Identification

Unique Protocol Identification Number
NCT02774616
Brief Title
BIO|MASTER.Ilivia Family / Plexa
Official Title
BIO|MASTER.Ilivia Family / Plexa
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotronik SE & Co. KG

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Tachyarrhythmia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
292 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ilivia ICD Family
Arm Type
Other
Arm Description
Implant of the new Ilivia ICD Family. Device measurements, pre-defined programming and Adverse Event Reporting
Arm Title
Plexa ICD lead
Arm Type
Other
Arm Description
Implant of the new Plexa ICD lead. Device measurements and Adverse Event Reporting
Arm Title
Ilivia ICD and Plexa lead
Arm Type
Other
Arm Description
Implant of the new Ilivia ICD Family and the new Plexa lead. Device measurements, pre-defined programming and Adverse Event Reporting
Intervention Type
Device
Intervention Name(s)
Ilivia ICD Family
Intervention Description
pre-defined device programming, measurements and follow-up schedule
Intervention Type
Device
Intervention Name(s)
Plexa ICD lead
Intervention Description
predefined follow-up schedule
Primary Outcome Measure Information:
Title
Ilivia Family Related SADE-free Rate Through 3 Months
Description
This endpoint measures the percentage of patients without serious adverse device effect (SADE) related to the ICD device
Time Frame
3 months
Title
Plexa Related SADE-free Rate Through 6 Months
Description
This endpoint measures the percentage of patients without serious adverse device effect (SADE) related to the "Plexa" lead
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Percentage of Patients With Successful Fast Ventricular Arrhythmia Conversion by ATP One-shot at 6-month Follow-up
Description
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
Time Frame
6 months
Title
Rate of Appropriate Right Ventricular Sensing at 3-month Follow-up
Description
The investigator is asked whether the sensing function of the Pleaxa lead in the right ventricle is appropriate
Time Frame
3 months
Title
Rate of Appropriate Right Ventricular Pacing at the 3 Months Follow-up
Description
The investigator is asked whether the pacing function of the Pleaxa lead in the right ventricle is appropriate
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Sticherling, Prof. Dr.
Organizational Affiliation
Universitätsspital Basel
Official's Role
Study Chair
Facility Information:
Facility Name
Liverpool Hospital
City
Liverpool
Country
Australia
Facility Name
Nambour General Hospital
City
Nambour
Country
Australia
Facility Name
Universitätsklinikum St. Pölten
City
St. Pölten
Country
Austria
Facility Name
Odense University Hospital
City
Odense
Country
Denmark
Facility Name
CHU Brest
City
Brest
Country
France
Facility Name
Hufeland Klinikum GmbH
City
Bad Langensalza
Country
Germany
Facility Name
HDZ NRW Bad Oeynhausen
City
Bad Oeynhausen
Country
Germany
Facility Name
Städtisches Klinikum Brandenburg GmbH
City
Brandenburg
Country
Germany
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
Country
Germany
Facility Name
Universitätsklinikum Freiburg
City
Freiburg
Country
Germany
Facility Name
SRH Wald-Klinikum Gera GmbH
City
Gera
Country
Germany
Facility Name
Westpfalz-Klinikum Kaiserslautern
City
Kaiserslautern
Country
Germany
Facility Name
Hegau-Bodensee-Klinikum Singen
City
Singen
Country
Germany
Facility Name
Universitätsklinikum Würzburg
City
Würzburg
Country
Germany
Facility Name
Chaim Sheba Medical Center
City
Ramat Gan
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
Country
Israel
Facility Name
Pauls Stradins Clinical University Hospital
City
Riga
Country
Latvia
Facility Name
National Heart Center Singapore
City
Singapore
Country
Singapore
Facility Name
Hospital de Bellvitge
City
Barcelona
Country
Spain
Facility Name
Hospital de Donostia
City
San Sebastian
Country
Spain
Facility Name
Hospital Universitario Virgen de Macarena
City
Sevilla
Country
Spain
Facility Name
Universitätsspital Basel
City
Basel
Country
Switzerland
Facility Name
Inselspital Bern
City
Bern
Country
Switzerland
Facility Name
Kantonspital Luzern
City
Luzern
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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BIO|MASTER.Ilivia Family / Plexa

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