Clinical trial NCT02181686: Iperia/Sentus QP Study
Official title: Iperia Family / Sentus QP Master Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Tachyarrhythmia
Keywords: Heart Failure
Iperia ICD family
Sentus QP left ventricular lead
Quadripolar CRT-D system
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2014-07-04
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient collective consists mainly of heart failure patients with CRT-D indication according to current guidelines. In addition 50 patients with an indication for single or dual chamber ICD will be enrolled in the study. The investigator will select patients who are appropriate for particiation from his general patient population.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Sentus QP LV lead: Serious Adverse Device Effect (SADE) free rate
timeFrame: 3 months
measure: Iperia ICD family: SADE free rate
timeFrame: 3 months
Secondary outcomes:
measure: LV pacing threshold
timeFrame: 3 months
Other outcomes:
measure: Collection of data of interest: Handling of LV lead during implantation
timeFrame: 3 months
Locations:
city: St. Poelten
country: Austria
facility: Landesklinikum
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Skejby
country: Denmark
facility: Aarhus University Hospital
city: Jyväskylä
country: Finland
facility: Jyväskylä Central Hospital
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabetes Zentrum
city: Gera
country: Germany
facility: SRH Wald-Klinikum
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Lübeck
country: Germany
facility: UKSH Campus Lübeck
city: Lüdenscheid
country: Germany
facility: Märkische Kliniken Lüdenscheid
city: Munich
country: Germany
facility: Klinikum München-Bogenhausen
city: Mönchengladbach
country: Germany
facility: Kliniken Maria Hilf GmbH
city: Stendal
country: Germany
facility: Johanniter Krankenhaus
city: Villingen-Schwenningen
country: Germany
facility: Schwarzwald-Baar Klinikum
city: Catanzaro
country: Italy
facility: Ospedale Pugliese Ciaccio
city: Riga
country: Latvia
facility: Paul Stradins Clinical University Hospital
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Zwolle
country: Netherlands
facility: Isala Klinieken
city: Singapore
country: Singapore
facility: National Heart Centre
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Lucerne
country: Switzerland
facility: Kantonsspital Lucerne
city: Lugano
country: Switzerland
facility: Cardiocentro Ticino
city: Zurich
country: Switzerland
facility: Triemlispital Zurich
city: Brighton
country: United Kingdom
facility: Russels Hall Hospital
Study officials:
affiliation: Schwarzwald-Baar Klinikum Villingen-Schwenningen, Germany
name: Werner Jung, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: