Iperia/Sentus QP Study

Heart Failure Clinical Trial

Official title:

Iperia Family / Sentus QP Master Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02181686
• Other study ID #: CR015
• 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

• Heart Failure
• Tachyarrhythmia

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