Iperia/Sentus QP Study

Completed

• Conditions: Heart Failure; Tachyarrhythmia

• Registration Number: NCT02181686
• Lead Sponsor: Biotronik SE & Co. KG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-02
• Study First Submitted QC: 2014-07-02
• Study First Posted: 2014-07-04
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-14
• Last Update Posted: 2015-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Iperia ICD family: SADE free rate	3 months	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.
Sentus QP LV lead: Serious Adverse Device Effect (SADE) free rate	3 months	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.

Secondary Outcome Measures

Name	Time	Method
LV pacing threshold	3 months	Lv pacing threshold measured in the final programmed pacing vector

Trial Locations

Locations (24)

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Jyväskylä Central Hospital; 🇫🇮 Jyväskylä, Finland

Aarhus University Hospital; 🇩🇰 Skejby, Denmark

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

Klinikum München-Bogenhausen; 🇩🇪 Munich, Germany

Kliniken Maria Hilf GmbH; 🇩🇪 Mönchengladbach, Germany

Schwarzwald-Baar Klinikum; 🇩🇪 Villingen-Schwenningen, Germany

Ospedale Pugliese Ciaccio; 🇮🇹 Catanzaro, Italy

Isala Klinieken; 🇳🇱 Zwolle, Netherlands

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain

Kantonsspital Lucerne; 🇨🇭 Lucerne, Switzerland

Russels Hall Hospital; 🇬🇧 Brighton, United Kingdom

Triemlispital Zurich; 🇨🇭 Zurich, Switzerland

Landesklinikum; 🇦🇹 St. Poelten, Austria

Paul Stradins Clinical University Hospital; 🇱🇻 Riga, Latvia

National Heart Centre; 🇸🇬 Singapore, Singapore

Cardiocentro Ticino; 🇨🇭 Lugano, Switzerland

Odense University Hospital; 🇩🇰 Odense, Denmark

Johanniter Krankenhaus; 🇩🇪 Stendal, Germany