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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02181686
Other study ID # CR015
Secondary ID
Status Completed
Phase N/A
First received July 2, 2014
Last updated July 14, 2015
Start date July 2014
Est. completion date June 2015

Study information

Verified date July 2015
Source Biotronik SE & Co. KG
Contact n/a
Is FDA regulated No
Health authority Austria: Federal Office for Safety in Health Care
Study type Observational

Clinical Trial Summary

The objective of this study is to confirm the safety and efficacy of the new Sentus OTW QP LV lead and Iperia ICD family. The study focuses on the safety and efficacy of the QP device system.


Recruitment information / eligibility

Status Completed
Enrollment 152
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient is able to understand the nature of the study and provides written informed consent.

- Patient meets a standard indication for CRT-D (Sentus QP group) or ICD therapy.

- Patient is able and willing to complete the planned follow-up visits at the investigational site.

- Patient accepts the Home Monitoring® concept.

- Age is = 18 years.

- Sentus QP group only: Patient is a candidate for a new (de novo) implant or an upgrade from an existing ICD or pacemaker utilizing a BIOTRONIK Sentus QP lead

Exclusion Criteria:

- Patient has a standard contraindication for CRT-D (Sentus QP group) or ICD therapy.

- Sentus QP group only: Currently implanted with an endocardial or epicardial LV lead or had prior attempt to place a LV lead.

- Sentus QP group only: Cardiac surgery procedure (coronary bypass graft, valve surgery, or ablation) that is planned to occur within 3 months after implantation.

- Patient is expected to receive ventricular assist device or heart transplantation within the next 3 months.

- Patient is pregnant or breastfeeding.

- Life expectancy of less than 3 months

- Participating in another cardiac clinical investigation with active treatment arm.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Austria Landesklinikum St. Poelten
Denmark Aalborg University Hospital Aalborg
Denmark Odense University Hospital Odense
Denmark Aarhus University Hospital Skejby
Finland Jyväskylä Central Hospital Jyväskylä
Germany Herz- und Diabetes Zentrum Bad Oeynhausen
Germany SRH Wald-Klinikum Gera
Germany Medizinische Hochschule Hannover Hannover
Germany UKSH Campus Lübeck Lübeck
Germany Märkische Kliniken Lüdenscheid Lüdenscheid
Germany Kliniken Maria Hilf GmbH Mönchengladbach
Germany Klinikum München-Bogenhausen Munich
Germany Johanniter Krankenhaus Stendal
Germany Schwarzwald-Baar Klinikum Villingen-Schwenningen
Italy Ospedale Pugliese Ciaccio Catanzaro
Latvia Paul Stradins Clinical University Hospital Riga
Netherlands University Medical Center Groningen Groningen
Netherlands Isala Klinieken Zwolle
Singapore National Heart Centre Singapore
Spain Hospital Clinic de Barcelona Barcelona
Switzerland Kantonsspital Lucerne Lucerne
Switzerland Cardiocentro Ticino Lugano
Switzerland Triemlispital Zurich Zurich
United Kingdom Russels Hall Hospital Brighton

Sponsors (1)

Lead Sponsor Collaborator
Biotronik SE & Co. KG

Countries where clinical trial is conducted

Austria,  Denmark,  Finland,  Germany,  Italy,  Latvia,  Netherlands,  Singapore,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Collection of data of interest: Handling of LV lead during implantation 3 months No
Primary Sentus QP LV lead: Serious Adverse Device Effect (SADE) free rate The safety of the LV lead will be evaluated by asking the investigator to record any adverse event. While all adverse events have to be recorded throughout the study, only the number of SADEs possibly or securely related to the LV lead will be the basis for endpoint calculation of the SADE-free rate. 3 months Yes
Primary Iperia ICD family: SADE free rate The safety of the Iperia ICD family will be evaluated by asking the investigator to record any adverse event. While all adverse events have to be recorded throughout the study, only the number of SADEs possibly or securely related to the pacemaker will be the basis for endpoint calculation of the SADE-free rate. 3 months Yes
Secondary LV pacing threshold Lv pacing threshold measured in the final programmed pacing vector 3 months No
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