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BIO|MASTER.Ilivia Family / Plexa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02774616
Recruitment Status : Completed
First Posted : May 17, 2016
Results First Posted : March 26, 2019
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG

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

Condition or disease Intervention/treatment Phase
Heart Failure Tachyarrhythmia Device: Ilivia ICD Family Device: Plexa ICD lead Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 292 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: BIO|MASTER.Ilivia Family / Plexa
Actual Study Start Date : June 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : March 2018

Arm Intervention/treatment
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

Plexa ICD lead
Implant of the new Plexa ICD lead. Device measurements and Adverse Event Reporting
Device: Plexa ICD lead
predefined follow-up schedule

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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02774616


Locations
Show Show 25 study locations
Sponsors and Collaborators
Biotronik SE & Co. KG
Investigators
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Study Chair: Christian Sticherling, Prof. Dr. Universitätsspital Basel
  Study Documents (Full-Text)

Documents provided by Biotronik SE & Co. KG:
Study Protocol  [PDF] November 14, 2016
Statistical Analysis Plan  [PDF] August 30, 2017

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Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT02774616    
Other Study ID Numbers: TA111
First Posted: May 17, 2016    Key Record Dates
Results First Posted: March 26, 2019
Last Update Posted: May 22, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Tachycardia
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes