Heart Failure Clinical Trial
Official title:
BIO|MASTER.Ilivia Family / Plexa
NCT number | NCT02774616 |
Other study ID # | TA111 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2016 |
Est. completion date | March 2018 |
Verified date | July 2018 |
Source | Biotronik SE & Co. KG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 292 |
Est. completion date | March 2018 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Australia | Liverpool Hospital | Liverpool | |
Australia | Nambour General Hospital | Nambour | |
Austria | Universitätsklinikum St. Pölten | St. Pölten | |
Denmark | Odense University Hospital | Odense | |
France | CHU Brest | Brest | |
Germany | Hufeland Klinikum GmbH | Bad Langensalza | |
Germany | HDZ NRW Bad Oeynhausen | Bad Oeynhausen | |
Germany | Städtisches Klinikum Brandenburg GmbH | Brandenburg | |
Germany | Universitätsklinikum Erlangen | Erlangen | |
Germany | Universitätsklinikum Essen | Essen | |
Germany | Universitätsklinikum Freiburg | Freiburg | |
Germany | SRH Wald-Klinikum Gera GmbH | Gera | |
Germany | Westpfalz-Klinikum Kaiserslautern | Kaiserslautern | |
Germany | Hegau-Bodensee-Klinikum Singen | Singen | |
Germany | Universitätsklinikum Würzburg | Würzburg | |
Israel | Chaim Sheba Medical Center | Ramat Gan | |
Israel | Tel Aviv Sourasky Medical Center | Tel Aviv | |
Latvia | Pauls Stradins Clinical University Hospital | Riga | |
Singapore | National Heart Center Singapore | Singapore | |
Spain | Hospital de Bellvitge | Barcelona | |
Spain | Hospital de Donostia | San Sebastian | |
Spain | Hospital Universitario Virgen de Macarena | Sevilla | |
Switzerland | Universitätsspital Basel | Basel | |
Switzerland | Inselspital Bern | Bern | |
Switzerland | Kantonspital Luzern | Luzern |
Lead Sponsor | Collaborator |
---|---|
Biotronik SE & Co. KG |
Australia, Austria, Denmark, France, Germany, Israel, Latvia, Singapore, Spain, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 |
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