Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
152 participants
OBSERVATIONAL
2014-07-31
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Sentus QP group
Patients with standard indication for CRT-D therapy who will be implanted with Sentus QP LV lead and the BIOTRONIK HF-T QP device.
No interventions assigned to this group
VR-T/DR-T group
Patients with standard indication for ICD therapy who will be implanted with either single chamber ICD or dual chamber ICD of the Iperia ICD family
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Biotronik SE & Co. KG
INDUSTRY
Responsible Party
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Principal Investigators
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Werner Jung, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Schwarzwald-Baar Klinikum Villingen-Schwenningen, Germany
Locations
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Landesklinikum
Sankt Pölten, , Austria
Aalborg University Hospital
Aalborg, , Denmark
Odense University Hospital
Odense, , Denmark
Aarhus University Hospital
Skejby, , Denmark
Jyväskylä Central Hospital
Jyväskylä, , Finland
Herz- und Diabetes Zentrum
Bad Oeynhausen, , Germany
SRH Wald-Klinikum
Gera, , Germany
Medizinische Hochschule Hannover
Hanover, , 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, , Germany
Ospedale Pugliese Ciaccio
Catanzaro, , Italy
Paul Stradins Clinical University Hospital
Riga, , Latvia
University Medical Center Groningen
Groningen, , Netherlands
Isala Klinieken
Zwolle, , Netherlands
National Heart Centre
Singapore, , Singapore
Hospital Clinic de Barcelona
Barcelona, , Spain
Kantonsspital Lucerne
Lucerne, , Switzerland
Cardiocentro Ticino
Lugano, , Switzerland
Triemlispital Zurich
Zurich, , Switzerland
Russels Hall Hospital
Brighton, , United Kingdom
Countries
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Other Identifiers
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CR015
Identifier Type: -
Identifier Source: org_study_id
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