Heart Failure Clinical Trial
Official title:
Iperia Family / Sentus QP Master Study
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 |
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.
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. |
Observational Model: Case-Only, Time Perspective: Prospective
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 |
Lead Sponsor | Collaborator |
---|---|
Biotronik SE & Co. KG |
Austria, Denmark, Finland, Germany, Italy, Latvia, Netherlands, Singapore, Spain, Switzerland, United Kingdom,
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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