BIO|MASTER.Ilivia Family / Plexa

May 10, 2019 updated by: Biotronik SE & Co. KG
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
292

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
        • Universitatsklinikum 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ilivia Family Related SADE-free Rate Through 3 Months
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Patients With Successful Fast Ventricular Arrhythmia Conversion by ATP One-shot at 6-month Follow-up
Time Frame: 6 months
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
Time Frame: 3 months
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
Time Frame: 3 months
The investigator is asked whether the pacing function of the Pleaxa lead in the right ventricle is appropriate
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biotronik SE & Co. KG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Christian Sticherling, Prof. Dr., Universitätsspital Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TA111

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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