Iperia/Sentus QP Study

Iperia Family / Sentus QP Master Study

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Tachyarrhythmia

• Study Type: Observational
• Enrollment (Actual): 152

Contacts and Locations

Study Locations

• Austria
  • St. Poelten, Austria
    • Landesklinikum
• Denmark
  • Aalborg, Denmark
    • Aalborg University Hospital
  • Odense, Denmark
    • Odense University Hospital
  • Skejby, Denmark
    • Aarhus University Hospital
• Finland
  • Jyväskylä, Finland
    • Jyväskylä Central Hospital
• Germany
  • Bad Oeynhausen, Germany
    • Herz- und Diabetes Zentrum
  • Gera, Germany
    • SRH Wald-Klinikum
  • Hannover, Germany
    • Medizinische Hochschule Hannover
  • Lübeck, Germany
    • UKSH Campus Lübeck
  • Lüdenscheid, Germany
    • Märkische Kliniken Lüdenscheid
  • Munich, Germany
    • Klinikum München-Bogenhausen
  • Mönchengladbach, Germany
    • Kliniken Maria Hilf GmbH
  • Stendal, Germany
    • Johanniter Krankenhaus
  • Villingen-Schwenningen, Germany, 78048
    • Schwarzwald-Baar Klinikum
• Italy
  • Catanzaro, Italy
    • Ospedale Pugliese Ciaccio
• Latvia
  • Riga, Latvia
    • Paul Stradins Clinical University hospital
• Netherlands
  • Groningen, Netherlands
    • University Medical Center Groningen
  • Zwolle, Netherlands
    • Isala Klinieken
• Singapore
  • Singapore, Singapore
    • National Heart Centre
• Spain
  • Barcelona, Spain
    • Hospital Clinic de Barcelona
• Switzerland
  • Lucerne, Switzerland
    • Kantonsspital Lucerne
  • Lugano, Switzerland
    • Cardiocentro Ticino
  • Zurich, Switzerland
    • Triemlispital Zürich
• United Kingdom
  • Brighton, United Kingdom
    • Russels Hall Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LV pacing threshold	Lv pacing threshold measured in the final programmed pacing vector	3 months

Other Outcome Measures

Outcome Measure	Time Frame
Collection of data of interest: Handling of LV lead during implantation	3 months

Collaborators and Investigators

• Sponsor: Biotronik SE & Co. KG
• Investigators: Principal Investigator: Werner Jung, Prof. Dr., Schwarzwald-Baar Klinikum Villingen-Schwenningen, Germany

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: July 2, 2014
• First Submitted That Met QC Criteria: July 2, 2014
• First Posted (Estimate): July 4, 2014

Study Record Updates

• Last Update Posted (Estimate): July 15, 2015
• Last Update Submitted That Met QC Criteria: July 14, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Heart Failure; Iperia ICD family; Sentus QP left ventricular lead; Quadripolar CRT-D system
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Failure; Tachycardia
• Other Study ID Numbers: CR015