Heart FailureNCT02774616

BIO|MASTER.Ilivia Family / Plexa

A study testing Ilivia ICD Family and Plexa ICD lead in people with Heart Failure and Tachyarrhythmia, run by Biotronik SE & Co. KG at 25 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Heart Failure, Tachyarrhythmia
What is being tested?: Ilivia ICD Family and Plexa ICD lead
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 292 participants
Where: 25 sitesin 10 countries
Study dates: Jun 2016to Mar 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

25 sites in 10 countries.

Country

City, postcode or hospital

25 sites in 10 countries

Germany10 sites

Hufeland Klinikum GmbH
Bad Langensalza
HDZ NRW Bad Oeynhausen
Bad Oeynhausen
Städtisches Klinikum Brandenburg GmbH
Brandenburg
Universitätsklinikum Erlangen
Erlangen
Universitätsklinikum Essen
Essen
Universitätsklinikum Freiburg
Freiburg im Breisgau
SRH Wald-Klinikum Gera GmbH
Gera
Westpfalz-Klinikum Kaiserslautern
Kaiserslautern
Hegau-Bodensee-Klinikum Singen
Singen
Universitätsklinikum Würzburg
Würzburg

Other trials in Germany

Spain3 sites

Hospital de Bellvitge
Barcelona
Hospital de Donostia
Donostia / San Sebastian
Hospital Universitario Virgen de Macarena
Seville

Other trials in Spain

Switzerland3 sites

Universitätsspital Basel
Basel
Inselspital Bern
Bern
Kantonspital Luzern
Lucerne

Other trials in Switzerland

Australia2 sites

Liverpool Hospital
Liverpool
Nambour General Hospital
Nambour

Other trials in Australia

Israel2 sites

Chaim Sheba Medical Center
Ramat Gan
Tel Aviv Sourasky Medical Center
Tel Aviv

Other trials in Israel

Austria1 site

Universitätsklinikum St. Pölten
Sankt Pölten

Other trials in Austria

Denmark1 site

Odense University Hospital
Odense

Other trials in Denmark

France1 site

CHU Brest
Brest

Other trials in France

Latvia1 site

Pauls Stradins Clinical University Hospital
Riga

Other trials in Latvia

Singapore1 site

National Heart Center Singapore
Singapore

Other trials in Singapore

About this study

Conditions: Heart Failure, Tachyarrhythmia
Being tested: Ilivia ICD Family, Plexa ICD lead
Medical subject headings: Heart Failure, Tachycardia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ilivia ICD FamilyDevice
pre-defined device programming, measurements and follow-up schedule
Plexa ICD leadDevice
predefined follow-up schedule

Study groups in NCT02774616
Study group	Role	What they receive
Ilivia ICD Family	Other	Implant of the new Ilivia ICD Family. Device measurements, pre-defined programming and Adverse Event Reporting Receives: Device: Ilivia ICD Family
Plexa ICD lead	Other	Implant of the new Plexa ICD lead. Device measurements and Adverse Event Reporting Receives: Device: Plexa ICD lead
Ilivia ICD and Plexa lead	Other	Implant of the new Ilivia ICD Family and the new Plexa lead. Device measurements, pre-defined programming and Adverse Event Reporting Receives: Device: Ilivia ICD Family; Device: Plexa ICD lead

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 6 months

Secondary outcomes (3)

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
Measured: 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
Measured: 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
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2016Mar 2018

First posted17 May 2016 (estimated)
Study startJun 2016
Primary completionDec 2017
Study completionMar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Heart FailureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 292 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02774616
Sponsor's protocol ID: TA111
Status last verified: Jul 2018
First submitted: 13 May 2016
Last updated: 22 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
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REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
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All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: BIO|MASTER.Ilivia Family / Plexa
ClinicalTrials.gov ID: NCT02774616
Acronym / sponsor ID: TA111
Conditions: Heart Failure, Tachyarrhythmia
Study type: Interventional
Recruitment status: Completed
Enrolment: 292 participants (actual)
Lead sponsor: Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
Study start: Jun 2016 (actual)
Primary completion: Dec 2017 (actual)
Study completion: Mar 2018 (actual)
First posted: 17 May 2016 (estimated)
Results: Posted 26 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Ilivia ICD Family	Other	Device: Ilivia ICD FamilyImplant of the new Ilivia ICD Family. Device measurements, pre-defined programming and Adverse Event Reporting
Plexa ICD lead	Other	Device: Plexa ICD leadImplant of the new Plexa ICD lead. Device measurements and Adverse Event Reporting
Ilivia ICD and Plexa lead	Other	Device: Ilivia ICD Family, Device: Plexa ICD leadImplant of the new Ilivia ICD Family and the new Plexa lead. Device measurements, pre-defined programming and Adverse Event Reporting

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ilivia ICD Familypre-defined device programming, measurements and follow-up schedule	Device	Ilivia ICD Family, Ilivia ICD and Plexa lead
Plexa ICD leadpredefined follow-up schedule	Device	Ilivia ICD and Plexa lead, Plexa ICD lead

Primary outcome

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
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

3 secondary outcomes

Percentage of Patients With Successful Fast Ventricular Arrhythmia Conversion by ATP One-shot at 6-month Follow-up
Time frame: 6 months
Rate of Appropriate Right Ventricular Sensing at 3-month Follow-up
Time frame: 3 months
Rate of Appropriate Right Ventricular Pacing at the 3 Months Follow-up
Time frame: 3 months

Results and safety

Results posted to the registry on 26 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ilivia ICD Family	95	80
Plexa ICD Lead	167	156
Ilivia ICD and Plexa ICD Lead	16	13

Primary outcome: Ilivia Family Related SADE-free Rate Through 3 Months

Time frame: 3 months. Count of participants. Unit: Participants

Measure	Ilivia Arm n = 92	Ilivia ICD and Plexa ICD Lead n = 12
Value	91	12

Ilivia Arm: p = 0.0004, exact binomial

Population analysed: These are all patients who either had a primary endpoint or who had reached 3 months of follow-up, or both.

Primary outcome: Plexa Related SADE-free Rate Through 6 Months

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Plexa Arm n = 136	Ilivia ICD and Plexa ICD Lead n = 13
Value	133	12

Plexa Arm: p = 0.0019, exact binomial

Population analysed: These are all patients who either had an endpoint or who reached 6 months of follow-up.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ilivia ICD Family	48 of 111 (43.2%)	52 of 111 (46.8%)	6 of 111
Plexa ICD Lead	56 of 183 (30.6%)	49 of 183 (26.8%)	6 of 183

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Heart Failure

Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Active, not recruitingObservational study
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
RecruitingPhase 3
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Acute Heart Failure
Recruiting
Renal Denervation in Patients With Atrial Fibrillation and Hypertension
Atrial Fibrillation (Paroxysmal), Hypertension
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christian Sticherling, Prof. Dr. study chair

Universitätsspital Basel

25 sites in 10 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Ilivia ICD Family and Plexa ICD lead in people with Heart Failure and Tachyarrhythmia, run by Biotronik SE & Co. KG at 25 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Germany, Spain, Switzerland, Australia, Israel and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ilivia Family Related SADE-free Rate Through 3 Months (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02774616.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2019.